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 ...

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 ...
RAPS

FDA Final Rule Mandates Electronic Registration of Device Establishments

The US Food and Drug Administration (FDA) has issued a final rule regarding  electronic device registration and listing requirements, putting into practice a long-awaited rule combining the ...
RAPS

FDA proposes waiving device registration fees for firms making less than $1M, in bankruptcy

The US Food and Drug Administration (FDA) is proposing to use recently granted authority from Congress to waive annual registration fees for small medtech manufacturers making $1 million or less ...
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 ...

DIAGNOS Successfully Completes the Renewal of US-FDA Medical Device Establishment Registration

Additionally, DIAGNOS would like to remind the reader that the legacy version of CARA, as a Medical Image Management and Processing System, remains cleared for commercialization in the USA.