Understanding Medical Device Regulatory Pathways - 510(k), PMA & Exemptions Webinar

PMA, and DeNovo submissions to bring medical devices to the US market. Recent 510(k) modifications for new technologies and safety advancements, along with AI integration, present significant ...
MD&M East

Factors Influencing FDA Clearance Time for Medical Devices: Evolution of a Critical Regulatory Pathway

The landscape of FDA medical device regulation has undergone a significant transformation. Today's regulatory environment presents both familiar challenges and entirely new complexities that device ...
MobiHealthNews

FDA looks to restrict older predicate devices, introduce new regulatory pathway

Yesterday, the FDA announced in a press release that it is eyeing potential updates to the agency’s 510(k) clearance pathway for medical devices. These could include a requirement for more modern ...
JD Supra

What FDA’s TEMPO Pilot and CMS’s ACCESS Model Mean for Medical Device Manufacturers

The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have launched two coordinated initiatives: the ...

MethodSense Supports ulrich medical to Fourth FDA Clearance for Innovative Computed Tomography (CT) Injector System

Collaboration underscores MethodSense’s role in accelerating market access and regulatory confidence for advanced ...
JD Supra

FDA’s 2026 CDS and General Wellness Guidance Updates

For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates ...
News Medical

Learn to navigate regulatory pathways for SaMD

Navigating the SaMD regulatory pathways is one of the most complex yet important aspects of product development for medical technology startups. Startups in this field are required to meet local ...

FDA Eases Wearable Oversight: Industry Leaders React at Newsweek Event

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
MedTech Dive

FDA guidance eases wearables oversight. But experts have questions about what’s next.

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...
MD&M East

FDA Chaos Threatens America’s First-to-Market Advantage

Recent turmoil at FDA has thrown the medical device industry into a state of regulatory chaos and confusion, threatening America’s first-to-market advantage in medtech. While I had hoped that ...