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May 21, 2025 08:00 ET | Source: Route 92 Medical, Inc.

Route 92 Medical Announces Results of SUMMIT MAX Clinical Trial Showing Highest First Pass Effect Ever Reported in a Randomized Endovascular Stroke Thrombectomy Study

Route 92 Medical announces results of the SUMMIT MAX randomized clinical trial and receipt of a 510(k) clearance for the HiPoint 88 Reperfusion System.
December 10, 2024 09:00 ET | Source: NeurAxis, Inc.

NeurAxis Inc. Announces FDA 510(k) Clearance of RED for Testing and Evaluation of Patients with Chronic Constipation

RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. NeurAxis Inc. will begin...
June 20, 2019 06:00 ET | Source: Parallax Health Sciences, Inc.

Parallax Health Sciences Announces Initiative to Obtain a 510(K) Clearance for its Fotodigm® Enabled Remote Patient Monitoring Platform

Positions Fotodigm® to be Issued a CPT Code for Medical Billing SANTA MONICA, CA, June 20, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – Parallax Health Sciences, Inc. (OTCQB: PRLX) (''Parallax''...
October 21, 2016 09:00 ET | Source: Colorado Therapeutics LLC

Colorado Therapeutics Receives 510(k) Clearance for a Novel Xenograft Implant for Soft Tissue Repairs

Broomfield, CO, Oct. 21, 2016 (GLOBE NEWSWIRE) -- Colorado Therapeutics LLC, a privately held medical device company with a proprietary technology platform for the production of innovative...
January 12, 2010 14:00 ET | Source: Michelson Diagnostics

Michelson Diagnostics VivoSight(TM) OCT Scanner Receives FDA 510(k) Clearance

ORPINGTON, United Kingdom, Jan. 12, 2010 (GLOBE NEWSWIRE) -- Michelson Diagnostics Ltd, the London, UK based developer and manufacturer of Optical Coherence Tomography (OCT) products, announced today...