Paige L. Cappelli

The U.S. Advanced Research Projects Agency for Health (ARPA-H) announced new funding for a “program to help AI-enabled medical tools maintain peak performance.” The new funding is through the Performance and Reliability Evaluation for Continuous Modifications and Usability of Artificial Intelligence (PRECISE-AI) program.

IRVINE, Calif., August 23, 2024 – Stryker, a global leader in medical technologies, announced today a definitive agreement to acquire Vertos Medical Inc., a privately held company providing a minimally...

The inaugural AAMI/FDA neXus medical device standards conference was held February 20-23, 2024 in Washington DC. The conference was hosted by the Association for the Advancement of Medical Instrumentation (AAMI). Additional information regarding the conference can be found here.

On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated recommendations on the 510(k) Program to “keep pace with the increasing complexity of rapidly evolving technology.” As stated on the FDA website: “[E]ach person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless” the device meets certain limited exemptions. A 510(k) submission provides, for the FDA’s review, safety and effectiveness data to show that a new device is substantially equivalent to a legally marketed predicate device.

The FDA recently announced that it is seeking a budget of $7.2 Billion for 2024, part of which is intended for “Advancing Medical Product Availability.” The portion of the requested budget directed to advancing access to safe and effective medical products would be used toward various initiatives, three of which are highlighted in the FDA’s announcement.

On September 28, 2022 the FDA announced a collaboration with the Veterans Health Administration (VHA), in particular the VA Ventures Innovation Institute. According to the FDA, the intent of the collaboration is to “help accelerate American medical device innovation to further improve and benefit public health. One goal of the collaboration is providing innovators with “straightforward, reproducible, and cost-effective testing methods throughout the product development cycle.”