medical device guru

Cardiovascular / Cardiology

FDA Grants Emergency Use Authorization to VitalConnect for Cardiac Monitoring in COVID-19 Patients

VitalConnect®, Inc., a leader in wearable biosensor technology, announced it was granted Emergency Use Authorization (EUA) status by the U.S. Food and Drug Administration (FDA) as part of the response to the COVID-19 pandemic. The FDA EUA will further enhance the capabilities of...

May 5, 2020

Cardiovascular / Cardiology

VentFree Respiratory Muscle Stimulator Receives FDA Emergency Use Authorization for Use During COVID-19 Pandemic 

Liberate Medical today announced that it has received Federal Drug Administration (FDA) Emergency Use Authorization for its VentFree™ Respiratory Muscle Stimulator, intended to be used to reduce disuse atrophy of the abdominal wall muscles, which may reduce the number of...

May 5, 2020

Diagnostics & Healthcare News

Cerus Corporation Announces FDA Approval for INTERCEPT Blood System for Plasma with Alternate Plastic Disposable Kits

Cerus Corporation (Nasdaq:CERS) announced today FDA regulatory approval for manufacture of INTERCEPT plasma with a new, alternative plastic disposable kit. The planned conversion to these new kits is part of the Company’s ongoing strategy to enhance its global supply chain...

May 4, 2020

Imaging Visualization & Navigation

Centerline Biomedical Completes First Human Patient in the United States with IOPS (Intra-Operative Positioning System)

Surgical navigation startup Centerline Biomedical, Inc. (Centerline), a Cleveland Clinic spin-off company, has announced the successful completion of the first in a series clinical cases in the United States as it begins limited launch of its innovative IOPS™ technology platform. The FDA-cleared...

May 4, 2020

Imaging Visualization & Navigation

Synaptive Medical Secures FDA Clearance for Evry

Synaptive Medical, a leader in robotic surgical visualization, announced today the company has secured clearance from the Food and Drug Administration (FDA) for its superconducting, head magnetic resonance imaging (MRI) technology, Evry™. Synaptive developed Evry to provide medical professionals with...

April 30, 2020

Cardiovascular / Cardiology

Abiomed Expands Product Portfolio with Acquisition of Cardiopulmonary Support Technology to Improve Outcomes for Patients

Abiomed, maker of the Impella heart pump, has acquired Breethe, developer of a novel extracorporeal membrane oxygenation (ECMO) system that will complement and expand Abiomed’s product portfolio to more comprehensively serve the needs of patients whose lungs can no longer provide sufficient...

April 30, 2020

Cardiovascular / Cardiology

HeartVista Closes $8.65M Series A Financing Led by Khosla Ventures

HeartVista, a pioneer in AI-assisted MRI solutions, today announced the closing of a $8.65M Series A financing round. The round was led by Khosla Ventures, Jeff Rothschild, Leslie Ventures, Open Field Capital, and additional investors. Combined with several grants from...

April 30, 2020

Cardiovascular / Cardiology

Lungpacer Medical Receives FDA Emergency Use Authorization to Wean Patients Off Mechanical Ventilation During Covid Crisis

Lungpacer Medical announced today that the U.S. Food and Drug Administration has issued Emergency Use Authorization (EUA) for the Company’s novel Diaphragmatic Pacing Therapy System (DPTS) for immediate use in patients on invasive mechanical ventilators at high risk of weaning...

April 29, 2020

Diagnostics & Healthcare News

Molekule Launches New Commercial Product, Air Pro RX, with FDA 510(k) Class II Medical Device Clearance

Molekule, the leader in reinventing air purification, today announced that the U.S. Food and Drug Administration (FDA) cleared the 510(k) premarket notification for its new medical-grade air purifier, Air Pro RX, classifying it as a 510(k) Class II Medical Device. The Molekule Air...

April 29, 2020