UMass Lowell

Demystifying Medical Device Classification & Approval with MITRE 8/19

Medical device startups, are you struggling to understand FDA regulations? Join our webinar with not-for-profit organization MITRE for help. Medical device startups, are you struggling to understand ...
Becker's Hospital Review

FDA cuts 8 software functions from medical device classification

The FDA is excluding eight software functions that were previously classified as medical device status under the 21st Century Cures Act. The FDA released the new provisions in an April 19 document in ...
GlobalData on MSN

LifeVac receives FDA De Novo classification for anti-choking device

LifeVac is approved for use as a single-use, non-powered, non-invasive airway clearance device.
JD Supra

Call for comments: FDA wants feedback on the distinct classification of existing device accessories into Class I

FDA's Center for Devices and Radiological Health (CDRH) issued a request for public comment on December 5, 2025, seeking feedback on the distinct classification of existing medical device accessories ...
JD Supra

Overview of Medical Device Regulation in China

How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the ...
Business Wire

Medical Device Market Outlook Report 2025-2030: Aging Demographic in Developing Countries Is Driving Major Growth, While Wearable Healthcare Device Accelerates Globally ...

DUBLIN--(BUSINESS WIRE)--The "Medical Device Market, by Device Type, Function, Durability, Therapeutic Segment, Risk Classification, Manufacture Method, Delivery/Acquisition, Operational Support Model ...
Medscape

FDA Panel Catches Up on Medical Device Classifications

The Gastroenterology and Urology Devices Panel of the US Food and Drug Administration's (FDA's) Medical Devices Advisory Committee deliberated yesterday on the classification of 4 categories of ...