The Silicon Review

Why Every MedTech Manufacturer Should Understand the 510(k) Database

Learn why understanding the FDA’s 510(k) database is essential for every MedTech manufacturer. Discover how it supports competitive analysis, regulatory planning, faster approvals, and smarter product ...
Healio

FDA grants 510(k) clearance for TMS as adjunctive for major depressive disorder in young people

The FDA has granted 510(k) clearance and a label expansion for a transcranial magnetic stimulation device to treat patients ...
Nasdaq

FDA grants Sonoma 510(k) approval for Microdacyn Hydrogel

The FDA posted online 510(k) approval for Sonoma Pharmaceuticals (SNOA)’ Microdacyn Hydrogel, which is intended for use of acute and chronic wounds, ulcers, cuts, abrasions and burns healing. The ...
Longview News-Journal

LifeSignals Receives FDA 510(k) Approval for UbiqVue™ 2A Multiparameter System

Cloud-Based System, Featuring Wearable Biosensor with Chest-Based SpO 2, Enables Active Patient Monitoring Across Hospital and Out-of-hospital Care Settings Replaces time-consuming manual spot ...
Business Wire

Simpson Interventions Announces both IDE approval from FDA for Acolyte™ Catheter System and 510(k) clearance for its Shadow Catheter™, adds Board Member

CAMPBELL, Calif.--(BUSINESS WIRE)--Simpson Interventions, Inc., a pioneering medical technology company, specializing in cardiovascular interventional devices, today announced achievement of major ...
Hosted on MSN

Respiree secures FDA 510(k) extension for cardio-respiratory wearable

The US Food and Drug Administration (FDA) has granted a second 510(k) clearance to expand the use of Respiree’s RS001 cardio-respiratory wearable to home-based settings. The clearance includes ...
Becker's ASC

CurveBeam Receives FDA 510(k) Approval for the pedCAT 3D Foot and Ankle Scanner

CurveBeam has announced it has received FDA 510(k) approval for pedCAT, an in-office 3D foot and ankle scanner, according to a news release from CurveBeam. pedCAT uses cone Beam Computed Tomography ...
Morningstar

GeneseeqPrime® Gains FDA 510(k) Clearance

TORONTO, Sept. 2, 2025 /PRNewswire/ - Geneseeq Technology Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for GENESEEQPRIME® NGS Tumor Profiling ...
Business Wire

Neurescue's Breakthrough Intelligent Balloon Catheter FDA 510(k) Cleared for Hemorrhage Control and IDE Approved for Cardiac Arrest

COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S.
Becker's ASC

Ophthalmic Laser Company Lumenis Receives FDA 510(k) Approval

Lumenis, an Israel-based medical laser company for ophthalmic and surgical applications, received FDA 510(k) clearance for the ResurFX, a fractional non-ablative laser module. The ResurFX is part of ...
Nasdaq

Apyx Medical Submits FDA 510(k) Premarket Notification for Innovative AYON Body Contouring System

Apyx Medical submits FDA 510(k) for AYON Body Contouring System, an innovative solution for comprehensive fat removal and skin tightening. Apyx® Medical Corporation has announced the submission of a ...