medical device guru

Cardiovascular / Cardiology

Inspira™ Technologies Begins Manufacturing of the ALICE™ CPB Device, ahead of planned 2023 FDA submission

Inspira Technologies OXY B.H.N. Ltd., a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned...

December 21, 2022

Cardiovascular / Cardiology

Movano Health On Track to File First FDA Submission for its Smart Ring’s SpO2 and Heart Rate Data Following Successful Pivotal Hypoxia Trial

Movano Health, a purpose-driven healthcare solutions company at the intersection of medical and consumer devices, today announces successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the University of California, San Francisco (UCSF) to assess the accuracy of its...

December 16, 2022

Cardiovascular / Cardiology

IRRAS Receives US FDA 510(k) Clearance for its Next Generation IRRAflow Control Unit

IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced that it received regulatory clearance from the United States Food, Drug, and Administration (FDA) to active all of the functionality on the next...

December 12, 2022

Cardiovascular / Cardiology

ReCor Medical Announces Consistent Reduction of Blood Pressure in Pooled Analysis of Three Clinical Trials at AHA 2022

ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. announced consistent and significant blood pressure (“BP”) lowering results across a range of patients with uncontrolled hypertension, including across differences in age, sex, baseline blood pressure, medication...

November 10, 2022

Cardiovascular / Cardiology

Saranas Announces Over 1,200 Patients Treated with the Early Bird® Bleed Monitoring System

Saranas, Inc. announced that over 1,200 patients have been treated with the Early Bird® Bleed Monitoring System, the first and only FDA-approved bleed detection system. The Early Bird was launched in 2019 following a De Novo classification by the U.S....

November 9, 2022

Cardiovascular / Cardiology

Johnson & Johnson to Acquire Heart Pump Maker Abiomed

Johnson & Johnson, the world’s largest, most diversified healthcare products company, and Abiomed, a world leader in breakthrough heart, lung and kidney support technologies, announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire...

November 2, 2022

Cardiovascular / Cardiology

OpSens Announces FDA Clearance for the SavvyWire™ for Use in Transcatheter Aortic Valve Replacement (TAVR) Procedures

OpSens Inc., a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, announced that it has received 510(k) regulatory clearance from the U.S. Food & Drug Administration (“FDA”) for the SavvyWire™ (“SavvyWire”), its new guidewire for...

September 20, 2022

Cardiovascular / Cardiology

Potrero Medical Receives FDA Breakthrough Device Designation for Accuryn AKI Predict Algorithm

Potrero Medical announced that the FDA granted Breakthrough Device Designation for their AKI Predict machine learning algorithm, for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in cardiac post-surgical intensive care patients. Joe Urban, Potrero...

September 13, 2022

Cardiovascular / Cardiology

Miracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. The PiCSO-AMI-II multicenter, randomized trial...

August 25, 2022