From A.I. to Musk’s Brain Chips, the F.D.A.’s Device Unit Faces Rapid Change
The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary ...
Medical Design and Outsourcing2d
Three strategies for unlocking the power of continuous integration/continuous deployment (CI/CD) for AI-powered medical devices
It’s no secret that AI-powered medical devices are revolutionizing healthcare, setting new standards for speed, precision, ...
Med Device Online13d
AI-Enabled Medical Device Manufacturers: Are You Prepared for Evolving FDA Oversight?
As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...
JD Supra12d
FDA Approvals of AI Medical Devices Rise Rapidly
Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a ...
Becker's Hospital Review9d
The future of FDA's medical device unit: 4 notes
Michelle Tarver, MD, PhD, a 15-year veteran of the agency, is stepping into a pivotal role as the new director of the FDA's device division, taking over for Jeffrey Shuren, MD. Dr. Shuren's tenure was ...
pharmaphorum1mon
MHRA's AI as medical device pilot opens for applicants
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regulatory ...
JD Supra21h
Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and ...
Hosted on MSN7mon
Opinion: Artificial intelligence will radically improve health care, but only if managed carefully
Examples range from ambient voice transcription tools that enable doctors or nurses to spend more time with their patients to diagnostic devices ... be seen how medical professionals and patients will ...
STAT4y
Medical devices
From virtual reality and artificial intelligence to CPAP machines and pulse oximeters, STAT keeps you up-to-date on the latest in medical device technology.
The New York Times7d
Artificial Intelligence
By Andrew Higgins The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary technology. By Christina Jewett ...
KYW Radio Philadelphia on MSN6d
Medical Report: Wearable devices that monitor overall health are flourishing
With the consistent development of new apps, wearable devices are playing a growing role in monitoring our overall health. KYW medical editor Dr. Brian McDonough has more.
Psychology Today7y
Artificial Intelligence
People often possess an array of devices that incorporate artificial intelligence ... There are currently no medical tests to definitively diagnose autism, but a recent study demonstrated that ...