Medical Device and Diagnostic Industry (MD+DI)

FDA’s AI Device Regulations: Key Updates & Compliance Strategies for Medtech Success

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...
MD&M East

FDA’s Registration List is Changing. Should You Be on It?

FDASIA was signed into law on July 9, 2012. This piece of legislation grants FDA the authority to collect user fees from industry to fund reviews of drugs, devices, and biologics. The changes to ...

FDA Approval Process for Medical Devices Course: How to Make the Most of the FDA Pre-submission Process (June 30, 2026 and July 1, 2026)

The course offers key opportunities in understanding U.S. medical device approval pathways, including 510(k), IDE, PMA, and De Novo. It enhances practical skills through interactive case studies and ...
Forbes

FDA Medical Device Cybersecurity And SBOMs: Compliance And Potential

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
Tallahassee Democrat

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

LAS VEGAS, NV, UNITED STATES, February 3, 2026 /EINPresswire.com/ — inHarmony Interactive, a leader in sound, vibration, and relaxation technology, has achieved U.S ...