medical devices

Dr. Erik Langhoff, chief medical officer and consultant for the Bronx Regional Health Information Organization, discusses how the agency is addressing safety and efficacy in AI.

The company intends to partner with healthcare, biopharmaceutical, medical device and diagnostic companies.

Connor Glass, founder and CEO of Phantom Neuro, explains how the company's muscle-machine interface for amputees is enabling the development of advanced prosthetic limbs designed to function as natural extensions of the human body.

The financing is in addition to a $1.8 million NIH grant for a Veris implantable physiological monitor.  

Gunnar Trommer of BCG X and Erik Adams of BCG give highlights of their upcoming HIMSS25 panel on the capital needed to develop and commercialize AI-powered medical devices and on completing regulatory milestones like 510(k) clearance.

The new draft guidance aims to help improve the accuracy of pulse oximeters in patients across the range of skin pigmentations.  

The guidance recommends a PCCP describe the planned AI-DSF modifications, the associated methodology to develop, validate and implement them, and assess the impact of the changes.  

The ECRI Institute's annual report from its Device Evaluation Program reflects enduring ramifications of the pandemic and cautions healthcare leaders about maintaining connectivity.

A. Hadi Chaudry says he foresees a growth in remote patient monitoring overall, not just face-to-face video visits.

More than 40 million patient records have been compromised this past year by incidents reported to the federal government in 2021.