Fierce Healthcare

CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

The Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced on Thursday ...
Hosted on MSN

FDA and CMS align to speed Medicare device coverage

The FDA and CMS have launched the RAPID coverage pathway to accelerate Medicare access to FDA-designated breakthrough medical devices by aligning regulatory review and coverage decisions earlier in ...
Business Wire

Tasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance

SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared its ...
RAPS

FDA Moves Three Device Types into Class II Special Controls

The US Food and Drug Administration (FDA) has proposed classifying three types of medical device products into its Class II regulatory controls scheme, subjecting them to special controls meant to ...
American Hospital Association

CMS, FDA announce pathway to expedite access to certain medical devices for Medicare beneficiaries

The Centers for Medicare & Medicaid Services and the Food and Drug Administration April 23 announced a new pathway to ...
MobiHealthNews

Amcom middleware now a Class II medical device

Amcom Software announced this week FDA 510(k) clearance for its Amcom (Commtech) Messenger middleware as a class II medical device intended for hospital use. The Amcom Messenger middleware sends ...
MobiHealthNews

FDA clears Verizon Wireless home health app as Class II medical device

Verizon Wireless' plans for an FDA-cleared mobile health platform focused on chronic disease management and other health conditions has been in the works for some time. The software platform, ...
RAPS

Updated: FDA Classifies Three Radiology Devices Into Class II

Editor's note: This article has been updated to reflect the release of an updated guidance related to medical image analyzers. The US Food and Drug Administration (FDA) on Tuesday classified two ...
Morningstar

FDA Qualifies MolecuLightDX Wound Measurement as a Medical Device Development Tool (MDDT) for Evaluating New Products in Wound Care

PITTSBURGH, Jan. 29, 2026 /PRNewswire/ - MolecuLight today announced that its MolecuLightDX® wound measurement has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device ...