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.
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.
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.
The pandemic has ushered in a novel era of cardiac health management, with remote patient monitoring at its forefront.
We all need to play a role to drive the innovative changes necessary and not wait for someone else to do it.
RPM products with medical-grade sensors can play a dynamic role in developing personalized medicine.
In this series we examine the future of the medical device industry—from manufacturing to the consumer-patient experience.
Seamless and personalized diabetes care has become a new normal.
Its success lies in a synergy between the technological and the clinical.
The deal will strengthen Stryker’s portfolio of smart technologies in its joint replacement business and provide products that help physicians make data-driven decisions.