Singular Health’s 3DICOM MD® Cloud Receives FDA 510(k) Clearance

Singular Health Limited (ASX: SHG), a medical technology company focused on creating a seamless healthcare ecosystem by ...
GlobalData on MSN

MRM Health receives FDA clearance for STARFISH-UC Phase IIb trial

MRM Health has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) ...
MassDevice

Medtronic wins FDA clearance for MiniMed Go app for InPen smart insulin pen

Medtronic (NYSE:MDT) announced today that the FDA granted 510(k) clearance for its MiniMed Go app for multiple daily ...
Los Angeles Business Journal

FDA Grants Pearl Third Clearance

Pearl, a dental technology startup based in West Hollywood, announced in mid-December the U.S. Food and Drug Administration ...

4Moving Biotech Receives FDA IND Clearance for 4P004, Strengthening Its Position as a Leading Innovator in Disease-Modifying Osteoarthritis Therapeutics

Moving Biotech (4MB), a clinical stage biotechnology company developing next-generation, disease-modifying therapies for osteoarthritis (OA), today announced that the U.S. Food and Drug Administration ...

AccurKardia Secures FDA 510(k) Clearance of and Launches AccurECG 2.0

AccurKardia, an ECG-led diagnostics software company focused on transforming ECG data into a more powerful diagnostic tool ...
MobiHealthNews

BrainSpace gets 510(k) nod for brain fluid management system and more FDA clearances

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

Satellos Receives Clearance by U.S. FDA and Global Regulators to Initiate Pediatric Phase 2 Study of SAT-3247 for Duchenne Muscular Dystrophy

Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) ("Satellos" or the "Company"), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, ...
MassDevice

BrainSpace wins FDA clearance for automated brain fluid management device

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

FDA Clears Toetal Solution's Ziptoe Hammertoe System

Company Positioned for Strategic Transaction MALVERN, PA / ACCESS Newswire / January 8, 2026 / Toetal Solution, Inc., a Runway Healthcare company, announced that it has received U.S. Food and Drug ...