Medical Device and Diagnostic Industry (MD+DI)

Understanding FDA's QMSR and Cybersecurity Mandates for Medical Devices

Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...
STAT

FDA taps AI executive to lead digital health center

Rick Abrmason, formerly a chief medical officer at a subsidiary of Harrison.ai, which develops AI products to interpret ...
Yahoo

Chatbots Are Not Medical Devices

In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As ...

FDA Eases Wellness Device Regulation, But Marketing Is Still Key

Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...

inHarmony Announces FDA Registration Across Vibroacoustic and Red Light Therapy Product Lines

Vibroacoustic Products Listed as Class I Medical Devices; Red Light Therapy Products Listed as Class II Medical Devices ...
Pancreatic Cancer Action Network

FDA Approves New Treatment for Patients with Locally Advanced Pancreatic Cancer: What You Need to Know

Optune Pax® with the chemotherapy combination of gemcitabine and nab-paclitaxel is the first treatment to be FDA approved in nearly 30 years for locally advanced pancreatic cancer.
Yahoo

FDA moves to rehire medical device, food safety and other staffers fired days earlier

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed on Oct. 14, 2015. (AP Photo/Andrew Harnik, File) WASHINGTON (AP) — Barely a week after mass firings at the ...
Medical Device and Diagnostic Industry (MD+DI)

Medical Device Companies Must Navigate Historic FDA Rule Change

FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...
HealthLeaders Media

FDA relaxes rules for wearable health devices

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...