NEW YORK – BioMérieux announced on Tuesday that it has submitted two gastrointestinal panels to the US Food and Drug Administration for 510(k) review. The BioFire FilmArray Gastrointestinal 1.1 Panel ...

Anchor Point Tracking, designed for use with the new RefleXion X2 platform, underpins SCINTIX therapy with higher fidelity biologic data. "Anchor Point Tracking represents the next major advancement ...

Edwards Lifesciences (NYSE:EW) has earned FDA 510(k) clearance for Ecliptis, its left atrial appendage (LAA) exclusion system. According to the FDA 510(k) database, the agency cleared the clip device ...

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HUNTLEY, Ill.--(BUSINESS WIRE)--Life Spine, Inc., a medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spinal disorders, announced today ...

Conexeu Sciences is rated Buy, leveraging a patented CXU platform targeting multi-billion-dollar regenerative medicine markets with a flagship wound care product. CNXU’s Ten-Minute Tissue™ aims for ...

WARRENDALE, Pa., June 23, 2026 (GLOBE NEWSWIRE) -- ECM Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance (K253521) for ECMT-100 WMD, a flowable ...

NEW YORK--(BUSINESS WIRE)--Pathway Labs today announced its public launch of EchoNext, the world’s first FDA-approved AI detection tool that reads standard 12-lead electrocardiograms (ECGs) to flag ...

This clearance represents the first implementation of Masimo’s OIRD detection capability in a hospital monitoring solution. By combining the trusted signal quality of best-in-class Masimo SET® with AI ...

AWCC* is an unofficial alternative to Alienware Command Centre of Windows for the Alienware Series Device on Linux, supporting almost all features that the Windows version supports, including custom ...

ISSOIRE, France--(BUSINESS WIRE)--Regulatory News: BIOCORP (FR0012788065 – ALCOR / Eligible PEA‐PME), a French company specialized in the design, development, and manufacturing of innovative medical ...