“Despite the recent advancements in treatment, individuals living with sickle cell disease continue to face significant challenges when receiving care. Inadequate knowledge of the disease among health care professionals, lack of research, and poor care coordination, among a few, lead to significant disparities in health outcomes,” said Mary Brown, President and CEO, Sickle Cell Disease Foundation. “We thank our partners, the Center for Inherited Blood Disorders and The Hills Tandem, for their steadfast commitment to this effort and look forward to our collaboration with the FDA to develop analytics and software approaches that will prioritize patients’ real-world experiences. Our collective goal is to improve quality of care and advance personalized medicine for all underserved communities affected by complex chronic and rare diseases through the emerging field of AI/ML health analytics.”

It is anticipated that the collaboration between the FDA and SCDF will lay the groundwork for best practices in the safe and effective use of AI and ML approaches for the development of novel digitally-derived endpoints. By analyzing longitudinal, de-identified patient-generated health data (i.e. granular biometric and self-reported symptoms data), socio-environmental data, and health information, collected from Institutional Review Board-approved studies led by SCDF in partnership with the Center for Inherited Blood Disorders (CIBD) and The Hills Tandem, the collaboration will develop a framework and software solutions to deploy on the data to help predict outcomes from lived experiences data. In addition, the research may provide insight into the use of real-world data to better design post-approval studies and labeling.

“At the FDA, patients are at the heart of everything we do. It is critical that patient input is incorporated into medical product development and throughout the Total Product Life Cycle,” said Vinay Pai, Ph.D., M.B.A., Digital Health Specialist in the Digital Health Center of Excellence at the U.S. Food and Drug Administration. “Collaborating with SCDF will help us to better understand and measure what matters most to patients and advance health equity, with the goal of improving the lives of those living with sickle cell and other rare diseases.”

About the Sickle Cell Disease Foundation

The Sickle Cell Disease Foundation (SCDF) was incorporated in 1957 and is the first and oldest Sickle Cell Disease community-based organization of its kind in the nation. As the only organization in California approved to provide Hemoglobin-Trait Counseling Services and direct the Sickle Cell Educator/Counselor Certification Training Course, SCDF provides life-enhancing education, services and programs for individuals living with Sickle Cell Disease. SCDF broadens public awareness, delivers effective advocacy initiatives, and promotes innovative therapies to ultimately find a cure. Learn more by visiting www.scdfc.org.

About the U.S. Food and Drug Administration

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetic, dietary supplements, products that give off electronic radiation, and regulating tobacco products. Learn more about the FDA Center for Devices and Radiological Health by visiting https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health.

Contacts

Naty Alvarez

(916) 826-7855

naty@perrycom.com

CHICAGO–(BUSINESS WIRE)–ASCO Annual Meeting – Massive Bio, a renowned leader in AI-driven oncology solutions and Mika Health, the premier oncology digital therapeutic platform, today announced a partnership to significantly expand patient access to psycho oncology services, next-generation sequencing (NGS) biomarker testing, and clinical trials. This collaboration will expand free patient access to Mika’s Digital Therapeutic to treat oncology specific fatigue, anxiety and depression as well as accelerate early access to the right on-market or investigative treatment and appropriate testing at the right time through Massive Bio’s platform.

“Patients who are waiting to find and access a clinical trial or on-market treatment that is effective in treating their cancer face tremendous challenges in their physical and mental health. Comprehensive NGS biomarker testing can greatly reduce that wait time by identifying targeted therapies for which they are eligible but is grossly under-utilized,” said Dr. Gandolf Finke CEO and Founder of Mika Health. “We’re thrilled to partner with Massive Bio to help more patients have more treatment options faster through improved access to genomic testing and matching to clinical trials that could save their lives – and to improve their experiences as they search for and access those treatments.”

The partnership is two-way. Patients receiving treatment on Mika’s personalized oncology Digital Therapeutic will have the ability to opt into Massive Bio’s AI-enabled clinical trial matching and NGS biomarker testing eligibility engine. Additionally, Massive Bio will make available Mika’s Digital Therapy to their cancer patient registry of hundreds of thousands of patients, expanding free access to digital psycho oncology services to treat fatigue, anxiety, and depression, a prevalent concern among those waiting to find the right treatments.

Dr. Selin Kurnaz, PhD, Co-Founder and CEO of Massive Bio, remarked “Our partnership marks a significant leap towards global personalized cancer care at a time when too many patients are struggling to find effective treatments. By combining our AI expertise with Mika Health’s comprehensive Digital Therapy, we can significantly enhance cancer patient outcomes and experiences with the expanded access to innovative therapies and direly needed patient support. This collaboration not only addresses the immediate needs of patients but also bridges critical gaps in mental and physical health care during their treatment journey.”

Mark Slaughter, Chief Strategy & Growth Officer at Mika Health, added, “As cancer treatments become more sophisticated and personalized, patients are increasingly unable to identify and access the targeted therapy and psycho-oncological support they need. By combining forces with Massive Bio, Mika Health aims to close the access gap, raise the pervasiveness of standard of care quality, and accelerate time to the right treatment for patients.”

Mika Health’s digital therapeutic supports patients through AI-powered personalized psychotherapy, symptom management, side effect interception, and educational resources. By leveraging data-driven insights, the app helps patients manage their cancer journey more effectively at home, and prepares them for consultations and enhancing communication with healthcare providers. This comprehensive approach reduces cancer-related distress and improves overall patient well-being, making it an invaluable tool for both patients and healthcare professionals.

Massive Bio’s advanced AI technology streamlines the clinical trial enrollment process, providing hundreds of thousands of patients with more opportunities to participate in groundbreaking treatments. With over 14,000 actively recruiting interventional clinical trials, Massive Bio ensures that patients have access to the most current and relevant trials for their specific conditions. This partnership will enhance patient matching efficiency, reduce manual effort, and ultimately improve treatment options and outcomes for cancer patients.

Despite evidence that NGS biomarker testing dictates survivorship, in the United States and Europe, evidence of its underutilization is well-documented. For example, less than 50% of lung cancer patients for whom the testing is a standard of care receive it.₁ The collaboration between Massive Bio and Mika Health will also benefit the research both companies are performing with pharmaceutical companies and patient advocacy groups, by providing real-world data and insights into patient experiences and treatment outcomes. This data can inform the development of new therapies, improve patient support services and access, and improve clinical trial design, ultimately leading to more effective cancer treatments and better patient care.

Dr. Arturo Loaiza-Bonilla, MD MSEd, Co-Founder and Chief Medical Officer of Massive Bio, emphasized, “Integrating Mika Health’s digital therapy with our AI system will empower both patients and oncologists with support that patients desperately need as they seek personalized and accessible treatments. This collaboration also expands awareness and utilization of biomarker and genomic testing when appropriate, optimizing chances of identifying effective therapies and clinical trials, benefiting all stakeholders involved in cancer care.”

About Massive Bio:

Massive Bio’s vision is to cover entire Pharma value chain with disruptive solutions to improve entire ecosystem from drug development to commercialization. Massive Bio is a unique tech-enabled big data platform with multiple use cases — addressing all friction points in end-to-end patient journey, enabling access to advanced treatment options for patients and optimizing drug commercialization for pharma. Utilizing AI to enhance equitable access and precision targeting for clinical trial matching, drug matching, and drug development, Massive Bio is committed to breaking down barriers in clinical trial enrollment, fostering value-based oncology decisions, and facilitating data-driven cancer treatment. Serving over four dozen pharmaceutical companies, contract research organizations, and hospital networks, Massive Bio has earned recognition from the National Cancer Institute with an SBIR contract, and it is founding member of CancerX Moonshot. Founded in 2015 by a team of clinical, technology, and M&A executives, Massive Bio boasts a global presence with nearly 100 people across 12 countries. For further details, please visit www.massivebio.com, https://askfiona.ai, https://drarturo.ai or interact with us on our social media channels.

About Mika Health

Mika is an app-based platform aimed at providing targeted and comprehensive support to people with cancer using digital technology. Through scientifically proven methods and techniques of therapy management, the Digital Therapeutics (DTx) helps patients to actively participate in their treatment and regain more quality of life – with daily symptom monitoring, psychologically oriented coaching courses, and AI-supported, personalized recommendations. To achieve this, Mika combines innovative machine learning technologies with a multimedia knowledge database of rigorously verified content, such as nutritional tips, exercise routines, or mindfulness training.

Fosanis, the Digital Health company behind Mika, was founded in Berlin in 2017 by Dr. Gandolf Finke and Dr. Jan Simon Raue and completed a Series-A financing round of more than 10 million euros in 2022. After tens of thousands of patients in Germany and the UK have already used the free DTx platform alongside their cancer therapy, the fifty-strong team of experts continues to expand its growth in the global HealthTech market. More information at www.mika.health.

₁ Robert NJ, et al. Biomarker tissue journey among patients (pts) with untreated metastatic non-small cell lung cancer (mNSCLC) in the U.S. Oncology Network community practices. ASCO 2021 Meeting Abstract. Available online at: https://meetinglibrary.asco.org/record/197070/abstract. Accessed on October 28, 2021.

Contacts

Media:

Massive Bio
Erkan Terzi
Chief Marketing Officer
+1 844 627 7246
pr@massivebio.com

Mika Health/ Fosanis GmbH
Shira Derasmo
+1 917 280 2497
shira@cuttlefishpr.com

Justus Meyer
+49 177 2908232
press@mika.health

CHICAGO–(BUSINESS WIRE)–Today, at the American Society for Clinical Oncology (ASCO) annual meeting, Mika Health, a global digital therapeutics developer specializing in meeting the needs of cancer patients, and Cancer Support Community (CSC), a recognized leader in cancer patient support and navigation, announced a partnership that will expand access to mental health and other vital support for patients and caregivers receiving cancer treatments. The organizations will debut the only AI-enabled evidence-based oncologic digital therapeutic that is completely free to patients and caregivers in the United States. The app-based platform was previously available only in Europe.

“Many patients have unidentified mental health challenges or are unable to access the support they seek. Figuring out which cancer and cancer treatment symptoms require additional medical interventions can be difficult, particularly with regards to depression, anxiety or other mental health challenges that can present with commonly dismissed experiences such as fatigue, lack of sleep, and decreased appetite,” said Dr. Gandolf Finke, founder and Managing Director of Mika Health. “Through this landmark partnership with the esteemed Cancer Support Community, we’re thrilled to bring patients and caregivers in North America anytime, anywhere access to our personalized AI-enabled support at a crucial time when the need for mental health care is at an all-time high.”

Mika helps patients understand their condition and reduce distress by staying on track with therapy by:

• Intercepting side effects and symptoms to enable clinical interventions
• Reducing impact of disease-related anxiety, stress, and depression
• Feeling more in control with insightful education, exercises, and advice on nutrition, emotional well-being and stress-reduction
• Orchestrating therapy for patients along their treatment continuum; medication adherence, appointment coordination, diagnostics, and more

The tool, which is certified for its quality and safety as a medical device in the EU, can be personalized to specific cancers and treatments to provide a personalized support experience. Mika is continuously co-developed and trusted by patients and their families, as well as clinicians all over the world.

“Through our patient experience research and work supporting hundreds of thousands of people impacted with cancer every year, we know that many people struggle to access the mental health support that they need and want,” said CSC CEO Sally Werner. “Our prior experience piloting app-based mental health interventions showed reductions in anxiety and depression so we are excited to partner with Mika in bringing their AI-enabled evidence-based digital therapeutic to people coping with the challenges that come with a cancer diagnosis,” Werner added. “We are thrilled to work alongside an innovative leader in digital therapeutics whose commitment to improving cancer patients’ access to care aligns so strongly with ours.”

About Mental Health and Cancer

One in three people treated for cancer in hospitals have a mental health condition such as depression or anxiety and those who received chemotherapy, radiation or surgery have the highest cumulative burden of psychiatric disorders¹. The good news is, people who receive support have fewer symptoms of depression and often see improvement in their physical health, are more likely to follow through with medical care and have a better quality of life with longer survival times². Ninety percent of studies show cost reduction following psychosocial intervention³.

However, in a survey of 600 cancer patients in the U.S. conducted by CSC, 60% of respondents never received a physician referral for a mental health screening and two in five cancer patients who asked for mental health support did not receive it, reporting access issues including financial barriers to treatment and telehealth, long appointment wait times, and difficulty getting an appointment. Most cancer patients report wanting support to help reduce distress and improve emotional well-being, such as exercise (66%) and nutrition programs (61%).⁴

About the Partnership

Mika and CSC will collaborate across several core areas:

• Access to Mika for patients, caregivers, and clinicians served at CSC’s nearly 200 network partner locations, and through other healthcare partnerships
• Co-development of multilingual and multicultural patient experience components to enhance health equity, inclusion, and diversity, and leverage CSC’s Patient Reported Outcomes (PRO) validated screener and digital assessments
• Co-development of a multilingual and multicultural caregiver experience with Patient Reported Outcomes (PRO) validated screener and digital assessments
• Joint Data Science and Clinical Research into psychosocial patient behaviors and treatments to improve patient and caregiver quality of life and mitigate distress, depression, anxiety, and fatigue. Additionally, the organizations will collaborate on research into complex therapy support platforms like CAR-T Cell Therapy and Radioligand Therapy

About Cancer Support Community

The Cancer Support Community is a global nonprofit that uplifts and strengthens people impacted by cancer. We are dedicated to fostering a community where people find connection, compassion, and knowledge. We provide professionally led support and navigation services, along with social connections and award-winning education — when, where and how impacted individuals prefer throughout their cancer experience. These resources are available at over 190 Cancer Support Community, Gilda’s Club, and healthcare partner locations as well as online and over the phone — all at no cost. We amplify the voices of those impacted by cancer through research and advocacy and create solutions that break down barriers to care and close the healthcare gap for communities whose members are disproportionately affected by cancer.

About Mika Health

Mika Health is an app-based platform aimed at providing targeted and comprehensive support to people with cancer using digital technology. Through scientifically proven methods and techniques of therapy management, the Digital Therapeutics (DTx) helps patients to actively participate in their treatment and regain more quality of life – with daily symptom monitoring, psychologically oriented coaching courses, and AI-supported, personalized recommendations. To achieve this, Mika combines innovative machine learning technologies with a multimedia knowledge database of rigorously verified content, such as nutritional tips, exercise routines, or mindfulness training.

Fosanis, the Digital Health company behind Mika, was founded in Berlin in 2017 by Dr. Gandolf Finke and Dr. Jan Simon Raue and completed a Series-A financing round of more than 10 million euros in 2022. After tens of thousands of patients in Germany and the UK have already used the free DTx platform alongside their cancer therapy, the fifty-strong team of experts continues to expand its growth in the global HealthTech market. More information at us.mika.health.

Editor’s Note:

We are pleased to arrange interviews or background talks with Mika and/or Cancer Support Community.

______________________________

¹ Chang, W.H., Lai, A.G. Cumulative burden of psychiatric disorders and self-harm across 26 adult cancers. Nat Med (2022). https://doi.org/10.1038/s41591-022-01740-3
² https://www.mhanational.org/cancer-and-mental-health
³ Mausbach BT, Decastro G, Schwab RB, Tiamson-Kassab M, Irwin SA. Healthcare use and costs in adult cancer patients with anxiety and depression. Depress Anxiety. 2020 Sep;37(9):908-915. doi: 10.1002/da.23059. Epub 2020 Jun 2. PMID: 32485033; PMCID: PMC7484454.

⁴ https://www.cancerandmentalhealth.com/wp-content/uploads/2024/02/Cancer-and-Mental-Health-Report.pdf

Contacts

Press:

Mika Health
Shira Derasmo
+1-917-280-2497
shira@cuttlefishpr.com

Cancer Support Community
Nathalie Casthely
+1-917-572-4517
ncasthely@cancersupportcommunity.org

NATICK, Mass.–(BUSINESS WIRE)–$ALUR #Allurion—Allurion Technologies, Inc. (NYSE: ALUR), a company dedicated to ending obesity, today announced the expansion of its Artificial Intelligence (AI)-powered weight loss coach, Coach Iris, to support patients prescribed GLP-1s and other anti-obesity medications and the first commercial agreements for its Virtual Care Suite (VCS) in the United States. With this update to Coach Iris, patients now have access to 24/7 personalized coaching and guidance specific to GLP-1s and other anti-obesity medications, such as treatment duration, side effects, and consequences of stopping their treatment. They can also engage with Coach Iris for tailored meal plans, recipes, exercise routines, stress management techniques, and motivational insights.

Coach Iris is part of the VCS, a dynamic weight-loss management suite powered by AI and featuring remote patient monitoring, predictive analytics, telehealth, and care team collaboration. The VCS is available to healthcare professionals offering GLP-1 and other anti-obesity medication therapy, bariatric surgery, and weight loss devices.

“I have seen firsthand how difficult it is for providers to offer best-in-class care for patients living with obesity. It demands close follow-up and lifestyle modification coaching at scale for sustained results,” said Dr. Shantanu Gaur, Founder and CEO of Allurion. “We believe VCS and, specifically, Coach Iris, can help ease this burden for them. We are excited to now work with our U.S. clinical partners to help them achieve better, more sustainable weight loss outcomes for their patients.”

Dr. Christopher McGowan, a triple board-certified physician in internal medicine, gastroenterology, and obesity medicine based in North Carolina and founder of True You Weight Loss, chose to integrate VCS and Coach Iris into his treatment algorithm. “As part of a clinical team of weight loss experts that provides minimally invasive and non-surgical weight loss options, we have a diverse patient population that requires personalized care and attention,” said Dr. McGowan. “Allurion’s Virtual Care Suite equips us with digital capabilities to provide even deeper, personalized care for our patients.”

According to a recent study by Blue Cross Blue Shield, 58% of patients discontinue use of GLP-1s before reaching a clinically meaningful health benefit, and 30% of patients discontinued use of the medications within the first month. Those who saw their doctor more often were more likely to continue the treatment, emphasizing the need for greater care management.

Dr. Alexander Shapsis, a triple board-certified physician and President of Atlantic Gastroenterology and EndoSlim Clinic based in New York, chose VCS, in part, to support his GLP-1 patients. “GLP-1s and other anti-obesity treatments demonstrate the most effective results when they are integrated into a holistic weight loss program,” said Dr. Shapsis. “This requires seamless communication between the provider and patients. We chose Allurion’s VCS and its remote patient monitoring technology because the platform was built specifically for weight loss clinics and properly supports the needs of my staff and patients.”

In an Allurion study, 87% of providers who used the VCS reported increased patient accountability, 88% reported increased efficiencies in their practice, and 82% reported increased patient engagement. “We are committed to adopting innovative technologies that enhance patient care. We immediately saw the immense value of Coach Iris and how it will help our patients stay engaged throughout their weight loss journey,” said Paul Barros, Co-Founder and CEO of Pivot Weight Loss. “This multi-purposed, digital tool works in tandem with our bariatric-trained dieticians, ensuring a blend of expert guidance and AI technology.”

“Weight loss clinics in the United States are experiencing explosive growth due to high patient demand for a number of therapies, including GLP-1s,” said Brian Conyer, VP of Digital Health at Allurion. “As a result, we believe there is a significant opportunity for our digital products and AI-powered technology to help clinics and providers meet the demand, maintain positive patient outcomes, and continue to grow.”

About Allurion

Allurion is dedicated to ending obesity. The Allurion Program is a weight loss platform that features the Allurion Gastric Balloon, the world’s first and only swallowable, procedure-less intragastric balloon for weight loss, and offers access to the Allurion Virtual Care Suite including the Allurion Mobile App for consumers, Allurion Insights for health care providers featuring the Coach Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor and manage weight loss therapy for patients regardless of their treatment plan: gastric balloon, surgical, medical or nutritional. The Allurion Gastric Balloon is an investigational device in the United States.

For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com.

Allurion is a trademark of Allurion Technologies, Inc. in the United States and countries around the world.

About True You Weight Loss

True You Weight Loss is the nation’s first and only physician-founded medical practice exclusively focused on providing non-surgical, state-of-the-art weight loss procedures and support. Dr. Lauren Donnangelo, Dr. Daniel Maselli, and Dr. Christopher McGowan are among the few physicians in the nation who are triple board-certified in internal medicine, gastroenterology, and obesity medicine, and leaders in the area of endobariatrics.

About Atlantic Gastroenterology

Atlantic Gastroenterology is a state-of-the-art clinic located in the New York area. The practice specializes in all aspects of gastroenterology, hepato-billiary diseases, and hepatology.

About Pivot Weight Loss

Pivot Weight Loss provides a modernized bariatric surgery journey to help patients achieve weight loss goals by combining expert surgeons, technology, and a friendly support team trained to encourage and educate, not judge.

Forward-Looking Statements

This press release may contain certain forward-looking statements within the meaning of the U.S. federal and state securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions and include statements regarding the ability of the Allurion Program, including the VCS, to improve patient and clinical outcomes, including outcome improvements over time, the impact of a behavior change coaching skills course, and the impact of gLP-1s on the Allurion Program. Forward-looking statements are predictions, projections and other statements about future events that reflect the current beliefs and assumptions of Allurion’s management based on information currently available to them and, as a result, are subject to risks and uncertainties. Many factors could cause actual future results or developments to differ materially from the forward-looking statements in this communication, including but not limited to (i) the ability of Allurion to obtain and maintain regulatory approvals for and successfully commercialize the Allurion Program, including the Allurion Balloon and the VCS, (ii) the timing of, and results from, our clinical studies and trials, (iii) the evolution of the markets in which Allurion competes, (iv) the ability of Allurion to defend its intellectual property, (v) the impact of the COVID-19 pandemic, the Russia and Ukraine war, and the Israel-Hamas conflict on Allurion’s business, (vi) Allurion’s expectations regarding its market opportunities, including those for the VCS platform, and (vii) the risk of economic downturns and a changing regulatory landscape in the highly competitive industry in which Allurion operates. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Allurion’s Annual Report on Form 10-K filed on March 26, 2024 (as subsequently amended) and other documents filed by Allurion from time to time with the U.S. Securities and Exchange Commission. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Allurion assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Allurion does not give any assurance that it will achieve its expectations.

Contacts

Global Media:
Cedric Damour
PR Manager
+33 7 84 21 02 20
cdamour@allurion.com

Investors:
Mike Cavanaugh, Investor Relations
ICR Westwicke
(617) 877-9641
mike.cavanaugh@westwicke.com

As part of the cooperation, BIOTRONIK will distribute Cardiomatics’ AI-powered ECG analysis solution alongside its net_ECG advanced ECG-Patch Holter Monitor in Germany. This combined offering will provide healthcare professionals with enhanced capabilities for precise cardiac monitoring and analysis.

Rafał Samborski, CEO of Cardiomatics, expressed his belief that their AI-based ECG analysis software will create great synergies with the BIOTRONIK ECG-Patch product portfolio and will nicely fit into the journey of cardiac patients.

The significance of this cooperation is underlined by the alarming statistics surrounding cardiovascular disease, the leading cause of global mortality. With approximately 17.9 million annual deaths attributed to cardiovascular complications, the imperative for improved early detection and management is clear.

Prof. Dr. David Duncker, Head of Hannover Heart Rhythm Center, Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany, expressed his excitement about the potential of AI to help in the in the early detection of cardiac rhythm abnormalities.

Cardiomatics has been at the forefront of developing AI solutions to enhance diagnostic cardiology since 2018. The Cardiomatics platform has analyzed over 250 thousand long-term ECG signals and garnered the distinction of being the first in its category to receive EU-MDR certification in October 2023.

Oliver Rehermann, Director of Marketing, e-Health & Connected Cardiac Care, BIOTRONIK Germany, stated that by combining Cardiomatics´ cutting-edge AI-powered ECG analysis solution with their net_ECG advanced ECG-Patch Holter Monitor, they aim to revolutionize the early detection and management of cardiac events. This collaboration supports their commitment to providing innovative solutions that enhance patient care and outcomes in cardiovascular health.

DentalMonitoring is a medical device software using image processing algorithms to analyze pictures of the oral cavity (hereinafter Scans). Scans are taken using the DM App, a smartphone, and the manufacturer’s proprietary hardware products. DentalMonitoring is indicated for use for patients over the age of 6 and reports results solely on permanent teeth.

The product is designed to assist healthcare professionals in remotely monitoring dental treatments, orthodontic treatments, oral health, and treatment progress. The results of DentalMonitoring are intended to be used as an aid in diagnosis and not on a stand-alone basis for clinical decision-making.

DentalMonitoring provides additional information compared to traditional orthodontic treatment follow-up. DentalMonitoring is an additional asset to ensure patient compliance to orthodontic treatment requirements. With DentalMonitoring, clinicians enjoy an elevated level of insight into treatment progress while patients enjoy increased convenience. Automated notifications and in-app communication with practice staff increase patient accountability and enhance communication between patients, healthcare providers, and caregivers.

With this approval, DentalMonitoring will also introduce the innovative SmartSTL feature to North American orthodontist customers. SmartSTL allows doctors to request updated STL files via the DentalMonitoring dashboard without bringing the patient back into the office.

“We are proud to be the new standard of care in orthodontics. This is a recognition of our 10 years of research and development in Deep Learning Artificial Intelligence. FDA approval of this improved version of DentalMonitoring software is a key milestone for DentalMonitoring and marks the beginning of a new era in orthodontics,” says Philippe Salah, CEO and co-founder of DentalMonitoring.

Since 2012, only four De Novos have been granted by the FDA Dental panel, and none were software-based devices. DentalMonitoring is the first Artificial Intelligence/Machine Learning-enabled Software as a Medical Device in dentistry, establishing a classification within FDA dental regulation numbers and product codes. With the grant of this De Novo and the creation of a new regulatory category, DentalMonitoring has paved the way for future innovations in the Software as a Medical Device in the dental field category.

This clearance is a result of Dental Monitoring’s investment in pushing digital health technologies to the forefront of dental care. DentalMonitoring’s innovation has benefited users with elevated clinical outcomes and increased their peace of mind.

About DentalMonitoring:

DentalMonitoring is transforming orthodontic care globally through our advanced AI-driven platform. Our mission is to empower orthodontic practitioners with precise, real-time treatment monitoring and decision-making tools. By enhancing the connection between clinicians and patients, we make it possible to optimize treatment outcomes and ensure high-quality, efficient, and personalized orthodontic experiences.

Contacts

Celine Cendras-White
Head of Marketing Communication
+33 18 695 0101
public-relations@dental-monitoring.com

Founded in 2020 with a mission to advance women and children’s health worldwide through medical innovations, Sonio has developed innovative IT solutions and AI features specifically tailored for obstetrics and gynecology ultrasound procedures. One of its flagship offerings, Sonio Detect, an FDA 510(k)-cleared AI assistant, utilizes sophisticated deep learning networks to ensure real-time image enhancement and elevate clinical accuracy, ultimately improving the quality of patient care.

Following the successful acquisition, Sonio will operate as an independent entity based in France, maintaining its autonomy in commercial expansion while ensuring the compatibility of its solutions with ultrasound devices from various manufacturers. By harnessing Samsung Medison’s expertise in ultrasound systems and combining it with Sonio’s cutting-edge AI capabilities, the collaboration aims to introduce groundbreaking AI-enhanced workflows that will drive significant advancements in patient outcomes and the quality of prenatal care.

Yong Kwan Kim, CEO of Samsung Medison, expressed enthusiasm about the partnership, stating, “Through the acquisition of Sonio, Samsung Medison remains committed to leveraging technology to enhance people’s lives. This collaboration holds the potential to revolutionize prenatal ultrasound examinations with state-of-the-art AI technology and reporting functionalities.“

Meanwhile, Cécile Brosset, CEO of Sonio, highlighted the synergistic benefits of the acquisition, emphasizing the growth opportunities it presents for both companies. “The partnership with Samsung Medison marks an exciting chapter in our journey to advance medical reporting technology and diagnostic software on a global scale. Together, we aim to drive innovation and address healthcare needs, including in underserved regions,” said Brosset.

The completion of the acquisition is contingent upon regulatory approvals, including the green light from the French Ministry of the Economy and Finance. As both companies gear up to combine their expertise and resources, the collaboration between Samsung Medison and Sonio sets the stage for transformative developments in the field of obstetrics and gynecology, ultimately enhancing patient care and medical diagnostics worldwide.

Artificial intelligence (AI) is rapidly revolutionizing the field of healthcare, but its integration in surgery has been relatively nascent. However, a recent study published in Nature¹ explores the potential of AI in surgery, highlighting its multifaceted improvements in preoperative, intraoperative, and postoperative care.

Artificial Intelligence in surgery: the study

The study emphasizes the significant global burden of surgical procedures, with over 330 million performed annually. It also highlights the existing challenges in terms of access to surgery, postoperative complications, and mortality rates. With the potential to address these issues, AI offers a promising way forward.

Traditionally, minimally invasive surgery has been at the forefront of improving surgical outcomes. However, the study points out that data-driven methods, empowered by AI, will play an increasingly important role in advancing surgical care and patient outcomes.

Integration of novel AI-powered digital interventions in the intraoperative setting

AI applications in surgery currently mostly rely on unimodal deep learning techniques. But transformer models, a recent breakthrough in neural network architectures, show great promise in enabling multimodal AI and foundation models. These models have the potential to handle diverse data formats and optimize surgical care across all stages of the process.

The integration of AI in surgery encompasses a wide range of applications. These include clinical risk prediction, automation and computer vision in robotic surgery, intraoperative diagnostics, enhanced surgical training, postoperative monitoring through advanced sensors, resource management, and discharge planning, among others.

The study envisions AI as a key tool to improve various aspects of surgical care. Preoperatively, AI can aid in patient selection, diagnostics, and surgical planning. For example, reinforcement learning algorithms have shown promise in identifying and maximizing tumor tissue removal while minimizing damage to functional anatomical tissues during neurosurgery. Virtual reality combined with AI-based segmentation systems can also enhance preoperative planning by aiding in complex surgical cases.

AI and preoperative diagnosis: the outcomes

Accurate preoperative diagnosis is crucial in surgical practice, and AI can significantly contribute to this area. The study highlights the successful application of AI algorithms in extracting unstructured radiological report data to enhance breast cancer diagnostics. Additionally, three-dimensional convolutional neural networks have demonstrated high accuracy in detecting pancreatic ductal adenocarcinomas, enabling early intervention and treatment.

AI plays a pivotal role in clinical risk prediction as well. By accurately assessing patient risks, it can facilitate enhanced patient selection, informed consent, and shared decision-making. However, the study also emphasizes the need for further research to mitigate biases and improve the overall accuracy of clinical risk scores.

By integrating AI into surgical care, healthcare professionals can optimize surgical workflows, reduce complications, and improve postoperative monitoring. The study concludes with a call for the development of novel transformer models capable of integrating and analyzing vast amounts of data, paving the way for even greater advancements in surgical AI in the near future.

In conclusion, the study published in Nature highlights the immense potential of AI for enhancing patient outcomes and surgical care. With its applications in diagnosis, risk prediction, and surgical planning, AI is poised to revolutionize the field of surgery. As technology continues to advance, the integration of AI promises a new era of surgical innovation and improved patient care.

1 Varghese, C., Harrison, E.M., O’Grady, G. et al. Artificial intelligence in surgery. Nat Med (2024). https://doi.org/10.1038/s41591-024-02970-3

HapSense: wearable skin sensor

HapSense emerges as a patent-pending wearable skin sensor that aims to streamline the analysis of skincare and cosmetic products. Developed through a collaborative effort between the P&G Singapore Innovation Centre, NTU Singapore, and the Agency for Science, Technology, and Research (A*STAR), HapSense sets out to deliver precise, objective, and quantifiable measurements of tactile sensations. By doing so, it effectively eliminates the guesswork often associated with skincare product development, offering invaluable insights for formulators seeking to create products that resonate with consumers.

Resembling a sleek signet ring, HapSense is comfortably worn on the fingertip, making it both convenient and unobtrusive. Its primary function lies in capturing data on friction and pressure in near real-time, allowing scientists and researchers to gain a deeper understanding of the effects various skincare products exert on the skin. What sets HapSense apart is its remarkable efficiency, speeding up product analysis by up to 10 times when compared to traditional skin-testing panels. Furthermore, its cost-effectiveness ensures accessibility, offering a viable alternative to conventional methods that often come with hefty price tags.

While HapSense finds its initial application in skincare and cosmetics, its versatility transcends boundaries, finding relevance across diverse industries.

• Textile and Fabric Care: Manufacturers can leverage HapSense to enhance the quality and sensory experience of fabrics, catering to consumers’ growing demand for comfort and luxury.
• Hair Care: Precise measurements of tactile sensations facilitated by HapSense hold the potential to revolutionize hair care product development, ensuring optimal performance and user satisfaction.
• Baby Care and Feminine Care: In sensitive areas such as baby care and feminine hygiene, HapSense plays a crucial role in ensuring safety and comfort, underscoring its significance in promoting overall well-being.

Ring-type sensor from NTU Singapore

NTU Singapore introduces a ring-type sensor, offering a parallel solution for measuring skin feel. Worn on the fingertip akin to HapSense, this innovative device captures data on friction and pressure, providing precise, objective, and quantifiable measurements of tactile sensation. Its development represents a significant stride towards enhancing skincare product analysis, offering researchers a powerful tool to unravel the intricacies of product efficacy and user experience.

The ring-type sensor from NTU Singapore brings forth a host of advantages, including:

• Accelerated Analysis: With the capability to expedite skincare product analysis by up to 10 times, the ring-type sensor streamlines the research and development process, enabling faster iterations and improvements.
• AI-Driven Insights: By harnessing multi-year data on product effects, the ring-type sensor facilitates AI-driven big data analysis, unlocking valuable insights that pave the way for personalized skincare regimes tailored to individual needs and preferences.

Beyond its primary application in skincare, the ring-type sensor holds promise across a spectrum of industries, including baby care, feminine hygiene, and more. Its versatility underscores its potential to revolutionize product development and enhance user experiences across various domains.

Market Snapshot: Verily and L’Oréal

In a testament to the growing convergence of technology and skincare, Alphabet’s Verily partners with L’Oréal to delve deeper into dermatological health. Leveraging AI and sensor technologies, this collaboration seeks to develop digital tools for skincare, further cementing the significance of technological innovation in reshaping the skincare landscape.

In summary, HapSense and the ring-type sensor represent a paradigm shift in skincare product analysis, heralding a new era of precision and efficiency. These wearable devices not only empower scientists and researchers but also hold the potential to transform the way skincare products are developed, marketed, and experienced. As the skincare industry continues to evolve, embracing technological innovations such as HapSense and the ring-type sensor will be paramount to driving progress and meeting the ever-evolving needs of consumers worldwide.

Under the visionary leadership of CEO Stéphane Bancel, Moderna has embarked on an ambitious mission to infuse AI into every aspect of its business, from research and manufacturing to legal and commercial operations.

Driven by a commitment to maximizing patient impact, Moderna’s adoption of ChatGPT Enterprise is not just a technological upgrade but a strategic move towards operational excellence. Moderna ensures that every employee equips themselves with the skills to leverage AI effectively, leading to rapid adoption and proficiency through a comprehensive transformation program.

The success story begins with mChat, an internal AI chatbot tool that quickly gained traction among employees, setting the stage for the seamless integration of ChatGPT Enterprise. With its launch, Moderna witnessed a surge in productivity as employees harnessed the power of AI to create hundreds of innovative solutions tailored to their needs.

Key milestones include the deployment of 750 GPTs company-wide, with 40% of weekly active users actively creating GPTs and engaging in 120 ChatGPT Enterprise conversations per week on average.

Dose ID, a standout application, streamlines clinical trial development by automating data analysis and augmenting decision-making processes as a GPT pilot. Additionally, ChatGPT Enterprise has empowered legal and corporate brand teams by streamlining compliance processes and enhancing storytelling capabilities.

Moderna’s commitment to AI-driven innovation and OpenAI’s cutting-edge technology set the stage for continued advancements in mRNA medicines and a positive impact on patients’ lives.