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Making the Most of Medical Wearables: Addressing Patient Adherence Challenges

Leave a Comment / 01-Digital Health, 04-Product Design & Development, Care Delivery, Home Health, MEDdesign, Medical Device, medical wearables, MedTech, patient compiance, remote patient monitoring / By

Making the Most of Medical Wearables: Addressing Patient Adherence Challenges     Patient adherence has historically been a challenge. Patients may deviate from treatment plans due to a variety of factors, including lifestyle choices, technological complexity or just plain forgetfulness. Studies have shown that 50-60% of patients with chronic illnesses miss medication doses, take the wrong …

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Leveraging Gamification and AI: The Future of Mental Health Care

Leave a Comment / 01-Digital Health, AI, AI/ML, Behavioral Health, Clinical Decision Support, gamification, Medical Device, MedTech, SaMD, Soapbox / By

Leveraging Gamification and AI: The Future of Mental Health Care     Mental health issues encompass a range of conditions affecting an individual’s emotional, psychological and social well-being. From depression and anxiety to more severe conditions like schizophrenia, these challenges have historically been addressed through various therapeutic modalities. In recent years, technology has begun to play …

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Unlocking Success in SaMD Product Launches Through AI

Leave a Comment / 01-Digital Health, 05-Quality/Regulatory, AI, AI/ML, Market Access, Medical Device, MedTech, regulatory compliance, SaMD, Soapbox / By

Unlocking Success in SaMD Product Launches Through AI     The field of digital health is rapidly transforming healthcare. With the integration of technology, clinical data and analytics, digital health is improving patient care, diagnostics and treatment methods. More specifically, Software-as-a-Medical-Device (SaMD)—a subsector of digital health—is gaining traction in both industry scale and innovative solutions. However, …

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President Biden Issues Executive Order on Artificial Intelligence

Leave a Comment / 01-Digital Health, 04-Product Design & Development, 05-Quality/Regulatory, AI, AI/ML, cybersecurity, data bias, data privacy, Health Data, Healthcare Policy, Medical Device, MedTech / By

President Biden Issues Executive Order on Artificial Intelligence     On October 30, President Biden issued an Executive Order establishing new standards for artificial intelligence (AI). The order focuses on safety and security, privacy protections, advancement of equity and civil rights, promotion of innovation and competition and advancing American leadership in AI. The Executive Order directs the …

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Drivers and Implications of Multi-Billion Dollar Acquisitions in Medtech

Leave a Comment / 01-Digital Health, 02-MedTech Economics, AI, AI/ML, Care Delivery, connected care, Home Health, Market Access, Medical Device, MedTech, mergers and acquisitions, telehealth / By

Drivers and Implications of Multi-Billion Dollar Acquisitions in Medtech     After a busy 2021, medical technology (medtech) mergers and acquisitions (M&As) dropped in 2022 largely due to the impacts of COVID-19, rising inflation and supply chain challenges. But some medtech companies were able to launch megadeals in 2022 despite macroeconomic conditions.[1] While billion-dollar deals are …

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FDA, MHRA and Health Canada Jointly Publish Guiding Principles for Predetermined Change Control Plans for ML-Enabled Medical Devices

Leave a Comment / 01-Digital Health, 05-Quality/Regulatory, AI, AI/ML, change control plans, global collaboration, Medical Device, MedTech, RC - Medtech Regulatory Resource Center / By

FDA, MHRA and Health Canada Jointly Publish Guiding Principles for Predetermined Change Control Plans for ML-Enabled Medical Devices     On October 24, the FDA, Health Canada, and the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly published “Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles.” Troy Tazbaz, Director of the Digital …

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Bringing Digital Health Products to the Global Market

Leave a Comment / 01-Digital Health, 05-Quality/Regulatory, Clinician Engagement, comliance, Digital Therapeudics, digitial health, Focus Article, Medical Device, MedTech, patient access, RC - EU MDR and IVDR, regulatory, regulatory harmonization, SaMD / By

Bringing Digital Health Products to the Global Market     In recent years, the growth and acceptance of digital health products has skyrocketed. Global regulation and market access for these devices, however, is as variable as the potential indications they address. We spoke with Megan Coder, Vice President for Product and Policy at the Digital Medicine …

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FDA Seeks Members for New Digital Health Advisory Committee

Leave a Comment / 01-Digital Health, 05-Quality/Regulatory, Digital Health, Medical Device, MedTech, RC - Medtech Regulatory Resource Center, regulatory advisory / By

FDA Seeks Members for New Digital Health Advisory Committee     The FDA is seeking subject matter experts to join its new Digital Health Advisory Committee. The role of the committee will be to support safe and effective regulation of digital health technologies while encouraging innovation, and to solicit views from technical and scientific subject matter …

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AdvaMed Launches New Digital Health Tech Division

Leave a Comment / 01-Digital Health, 05-Quality/Regulatory, Medical Device, MedTech / By

AdvaMed Launches New Digital Health Tech Division     AdvaMed has formed a new division, AdvaMed Digital Health Tech, to represent digital medical technology companies and promote the critical role of data and digital medtech in transforming health care. The group, which is led by Shaye Mandle, former President and CEO of the Medical Alley Association, …

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Striding Towards Recovery: How Gait Analysis Aids Elderly Rehabilitation

Leave a Comment / 01-Digital Health, Care Delivery, Chronic Care Management, eldery care, gait analysis, Medical Device, MedTech, remote patient monitoring, Soapbox / By

Striding Towards Recovery: How Gait Analysis Aids Elderly Rehabilitation     Gait analysis, the study of a person’s walking pattern, is a crucial health indicator that has gained recognition as the sixth vital sign, especially in the context of elderly health care. Beyond its apparent role in assessing mobility, gait analysis can offer invaluable insights into …

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