Zacks Investment Research on MSN

CapsoVision submits FDA 510(k) for AI-assisted module in CapsoCam Plus

CapsoVision, Inc. CV recently announced that it has submitted a 510(k) application to the FDA for approval to add an AI-based ...
Zacks Investment Research on MSN

KRMD submits 510(k) to use FreedomEDGE system with oncology biologic

KORU Medical Systems, Inc.KRMD recently announced that it has submitted a 510(k) premarket notification for FDA clearance to ...
Morningstar

Regenity Biosciences Marks 63rd FDA 510(k) Clearance with Expansion of Neurosurgical Portfolio

PARAMUS, N.J., Nov. 25, 2025 /PRNewswire/ -- Regenity Biosciences, a global leader in regenerative medicine and Linden Capital Partners portfolio company, today announced its 63rd FDA 510(k) clearance ...
Becker's ASC

Hansen Medical Receives FDA 510(k) Clearance for Peripheral Vascular Interventions System

Hansen Medical has announced it has received FDA 510(k) clearance for its Magellan Robotic System for peripheral vascular interventions, according to a news release. The system is designed to ...
Healio

FDA grants 510(k) clearance to devices that streamline Hyqvia administration

Please provide your email address to receive an email when new articles are posted on . The FDA granted 510(k) clearance to two devices, HyHub and HyHub Duo, that act as docking stations for dual vial ...
Business Wire

Ruthless Spine Announces Intellectual Property News and 510(k) Clearance on Revolutionary Spinal Instrument

LOS ANGELES--(BUSINESS WIRE)--Ruthless Spine today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the NavJam™ Jamshidi device, and as of today, U.S. Patent ...
Morningstar

Respiree Secures Second FDA 510(k) Clearance, Expands Cardio-Respiratory Wearable to Home Use via 1Bio™ Connected Care Platform

HOUSTON and SINGAPORE, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Respiree, a health tech company developing artificial intelligence (AI) platforms to manage disease progression across the healthcare continuum ...
Nasdaq

Microbot Medical® Receives FDA 510(k) Clearance for Its LIBERTY® Endovascular Robotic System

The Company’s Initial Addressable Market Includes Approximately 2.5 Million Peripheral Endovascular Procedures in the U.S. Annually CEO, President & Chairman to Present Live Webcast at the H.C.
Nasdaq

Monogram Announces FDA 510(k) Clearance For Monogram MBôs TKA System

(RTTNews) - Monogram Biosciences Inc.(MGRM), Monday announced that the U.S. Food and Drug Administration or FDA has granted 510(k) clearance for its Monogram mBôs TKA System, a robotic-assisted ...
Healio

FDA grants 510(k) clearance to in vitro blood-based Alzheimer’s biomarker device

Please provide your email address to receive an email when new articles are posted on . Amyloid plaques are one telltale sign of Alzheimer’s disease pathology in blood plasma. A blood-based diagnostic ...
Business Wire

SMAIO Receives FDA 510(k) Clearance for “K-rod”, its Patient-specific Union Rod

LYON, France--(BUSINESS WIRE)--Regulatory News: SMAIO (Software, Machines and Adaptative Implants in Orthopaedics – Euronext Growth Paris ISIN: FR0014005I80 / Ticker: ALSMA, eligible for PEA-PME ...