AI/ML-based SaMD: Trends in Litigation
This pioneering area of technology comes with new risks and questions of liability.
Tag Archives: wearables
The Regulatory Aspects of AI/ML-based SaMD
Modern technology has given rise to new legal questions. How does FDA regulate machine-learning computers that are changing so rapidly – given that the approved product may be drastically different than the product that ends up on the market? These questions arise from a lack of understanding of the complex nature of AI/ML-based SaMD, the opaqueness of the regulatory framework, and a dearth of relevant case law.
Six Steps to Finding Adhesives Compatible with Fragile Skin
Adhesive selection can make or break the success of a stick-to-skin wearable device. This article reviews six questions to ask the next time you design a device intended for wear on fragile skin.
Effective Manufacturing Test Strategies to Improve the Quality of Connected Medical Devices
Adding wireless connectivity to medical devices brings convenience to patients, and can facilitate more effective healthcare delivery and lower healthcare costs. Its success depends on the ability of manufacturers to produce reliable, connected products that do not fail prematurely in the field.
Incidence of Severe Cardiovascular Conditions Fuels Cardiac Arrhythmia Monitoring Devices Industry
The pandemic has ushered in a novel era of cardiac health management, with remote patient monitoring at its forefront.
The Great Equalizer: How Digital Health Is Democratizing Healthcare
We all need to play a role to drive the innovative changes necessary and not wait for someone else to do it.
How Remote Patient Monitoring and Biomarkers Are Changing in Clinical Research
RPM products with medical-grade sensors can play a dynamic role in developing personalized medicine.
Patient Engagement and Connected Medical Devices: Building the Next Generation of Wearable Devices to Enhance Remote Patient Care
In this series we examine the future of the medical device industry—from manufacturing to the consumer-patient experience.
Innovations in Self-Monitoring Blood Glucose Devices Will Impact Healthcare Services
Seamless and personalized diabetes care has become a new normal.
Future of Specialty Telemedicine
Its success lies in a synergy between the technological and the clinical.
