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Cardiovascular / Cardiology
Imperative Care Announces FDA Clearance and Initial Cases of Zoom RDL, the First Stroke-Specific Radial Access Platform for Mechanical Thrombectomy
Imperative Care, Inc., announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Zoom™ RDL Radial Access System, the company’s latest innovation in elevating stroke care and the first radial access platform developed specifically for ischemic stroke treatment. Zoom...
January 4, 2023
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
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