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Diagnostics & Healthcare News

BioIntelliSense Announces FDA Clearance of the BioSticker, a Single-Use Medical Device Enabling 30 Days of Continuous Vital Signs Monitoring

BioIntelliSense, Inc., a continuous health monitoring and clinical intelligence company, today announces the U.S. commercial launch of its medical grade Data-as-a-Service (DaaS) platform and FDA 510(k) clearance of the BioSticker™ on-body sensor for scalable remote care. BioIntelliSense offers a new...

January 28, 2020

Diagnostics & Healthcare News

Dimer Offers New Germ-Killing Robot to Disinfect Airplanes at Key US Airports to Protect Passengers from Coronavirus Outbreak

Dimer UVC Innovations is offering its GermFalcon®, a germ-killing robot that sanitizes airplanes, to assist airlines and federal agencies disrupt the spread of a new pneumonia-like illness originating in the Wuhan region of China. The service is being offered at no...

January 23, 2020

Diagnostics & Healthcare News

Phagenesis Wins FDA Breakthrough Nod for Phagenyx System for Restoring Swallowing

Phagenesis Ltd., a pioneering leader in the treatment of dysphagia, is pleased to announce today that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Phagenyx System. The Phagenyx System is a...

January 14, 2020

Diagnostics & Healthcare News

AI Saving Brain: FDA Clears Aidoc’s Complete AI Stroke Package

Aidoc, the leading provider of AI solutions for radiologists, today announced that the US Food and Drug Administration (FDA) has cleared its AI solution for flagging Large-Vessel Occlusion (LVO) in head CTA scans, marking Aidoc’s fourth FDA-cleared AI package. Combined with Aidoc’s...

January 13, 2020

Diagnostics & Healthcare News

TAP At-Home Blood Collection System Now FDA Cleared

Seventh Sense Biosystems, Inc. (7SBio) announced today that the company has received U.S. Food and Drug Administration (FDA) 510(k) authorization to extend its existing clearance to include blood collection by laypersons. Regulators are also allowing the device to be used...

January 3, 2020

Diagnostics & Healthcare News

Opsens Inc. Announces 510(k) Clearance from the FDA to Market its Diastolic Pressure Algorithm

Opsens Inc. announces 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market its diastolic pressure algorithm (“dPR”). Coronary physiology has been in constant evolution with the expanded use of Fractional Flow Reserve (“FFR”) and the support of strong...

December 23, 2019

Diagnostics & Healthcare News

Baebies Announces CE Mark for FINDER, an Innovative Near-Patient Testing Platform for Glucose-6-Phosphate Dehydrogenase 

Baebies is pleased to announce that FINDERTM, a near-patient testing platform, now has CE Mark as an In Vitro Diagnostic device (IVD) and is commercially available in Europe and other countries that recognize CE Mark. The CE-Marked platform includes an instrument and...

December 19, 2019

Diagnostics & Healthcare News

ImpediMed Receives FDA 510(k) Clearance of SOZO for Expanded Indication

ImpediMed Limited (ASX.IPD), a medical software technology company that non-invasively measures, monitors and manages fluid status and tissue composition using bioimpedance spectroscopy (BIS), recently announced the issuance of a further 510(k) clearance for SOZO® by the U.S. Food and Drug...

December 12, 2019

Diagnostics & Healthcare News

Beta Bionics Receives FDA Breakthrough Device Designation for the iLet Bionic Pancreas System

Beta Bionics, Inc. — a medical technology company developing and aiming to commercialize the world’s first fully automated bionic pancreas — today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its investigational...

December 11, 2019