medical device guru

Cardiovascular / Cardiology

Thermedical’s Groundbreaking SERF Ablation System Earns FDA’s Breakthrough Device Designation

Thermedical®, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate® catheter....

May 19, 2020

Cardiovascular / Cardiology

FDA Issues Emergency Use Authorization for Eko’s ECG-based Low Ejection Fraction Screening Algorithm, Designed to Improve Detection of Heart Failure During COVID-19 Pandemic

Eko, a digital health company building AI-powered screening and telehealth solutions to fight cardiovascular disease, today announced that the U.S. Food and Drug Administration (FDA) has issued the company an Emergency Use Authorization (EUA) for its novel ECG-based algorithm that can provide...

May 13, 2020

Cardiovascular / Cardiology

CardioFocus Announces US FDA Approval of HeartLight X3 System for the Treatment of Atrial Fibrillation

CardioFocus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the next-generation HeartLight® X3 Endoscopic Ablation System for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). Approval of the HeartLight X3 System came as a result...

May 12, 2020

Cardiovascular / Cardiology

ZOLL TherOx Receives CE Mark Approval for Supersaturated Oxygen Therapy

ZOLL Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, announced today it has received CE Mark approval to market and distribute its SuperSaturated Oxygen (SSO2) Therapy System in Europe. SSO2 Therapy provides interventional cardiologists with the first...

May 7, 2020

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

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