Regulatory Approvals

CroíValve Announces FDA IDE Approval and Initiation of its Early Feasibility Study

CroíValve, an Irish-U.S. based medical device company with a novel, transcatheter solution for tricuspid regurgitation (TR), today announced initiation of its Early Feasibility Study...

FDA clears SnoreLessNow mandibular advancement device

SnoreLessNow announced today that the FDA granted 510(k) clearance for its over-the-counter dental device. Known as SomniFit-S in Europe, the Anti-Snore Mouth Guard+ reduces snoring...

FDA grants breakthrough nod for Pi-Cardia leaflet modification device for TAVR

Pi-Cardia announced today that the FDA granted breakthrough device designation for its ShortCut leaflet modification device. ShortCut facilitates valve-in-valve transcatheter aortic valve replacement (TAVR) procedures...

Modular Medical seeks FDA 510(k) clearance for MODD1 insulin pump

US-based insulin delivery technology company Modular Medical has submitted its next-generation MODD1 insulin pump to the US Food and Drug Administration (FDA) for 510(k)...

Biocomposites’ investee Renovos Biologics receives FDA Breakthrough Device Designation for its synthetic nanoclay bone fusion gel, RENOVITE® BMP-2

Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for regenerating bone and managing infection in bone and soft...

Enspectra’s VIO System secures FDA 510(k) clearance

Enspectra Health has received FDA 510(k) clearance from the US Food and Drug Administration (FDA) for VIO System, a non-invasive skin imaging technology. By combining...

iRhythm secures CE mark for Zio monitor and ZEUS system

US-based medical equipment manufacturer iRhythm Technologies has received the CE mark for its next-generation long-term ambulatory cardiac monitor, Zio monitor ECG system. The Zio monitor...

EndoSound secures FDA 510(k) approval for EndoSound Vision System

US-based medical technology company EndoSound has received the US Food and Drug Administration (FDA) 510(k) approval for its EndoSound Vision System (EVS). The EVS is...

Belkin Vision’s glaucoma laser receives 510(k) clearance from FDA

Israeli medical device company Belkin Vision has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its glaucoma laser, the Eagle...
1...575859...115Page 58 of 115

Latest articles