Ceribell received breakthrough device designation for its LVO stroke detection monitor, and Naox Technologies secured 510(k) clearance for its in-ear EEG device.

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

BrainSpace announced that the FDA granted 510(k) clearance for its Intellidrop automated brain fluid management system.

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

The rapid molecular chlamydia and gonorrhea self-test provides results in 30 minutes from a self-collected swab sample, the firm said.

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 ...

KORU Medical’s Freedom Infusion System enables, simplifies, and enhances the delivery of large-volume subcutaneous drugs. Supporting drug products with various requirements for viscosity, flow rate, ...

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 ...

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 ...

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 ...

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 ...