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 ...
360Dx

PathAI Receives FDA Breakthrough Device Designation for AI-Based Dermatopathology Solution

The software is designed to analyze digital pathology whole-slide images of skin lesions and aid pathologists in their review.
Nasdaq

GeneDx Granted FDA Breakthrough Device Designation for its ExomeDx™ and GenomeDx™ Testing

Designation highlights GeneDx innovation in clinical whole genome and whole exome testing and accelerates the pathway for FDA authorization of these novel diagnostic tests With more than 2.5 million ...
Business Wire

QIAGEN Gains U.S. Clearance of Higher-Throughput QIAstat-Dx Rise, Expanding Patient Access to Rapid Syndromic Testing

GERMANTOWN, Md. & VENLO, Netherlands--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of QIAstat‑Dx Rise – a version of the QIAstat-Dx automated ...