medical device guru

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
Cardiovascular / Cardiology
Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch® Ventricular Restoration System
Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch® Ventricular Restoration System. Currently being evaluated in the CORCINCH-HF pivotal...
July 13, 2022
Cardiovascular / Cardiology
Okami Medical Announces FDA 510(k) Clearance of the LOBO-7 and LOBO-9 Vascular Occluders to Address a Wide Range of Peripheral Embolization Cases
Okami Medical Inc., a medical device company focused on developing innovative solutions that address key unmet clinical needs in peripheral vascular intervention, announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest...
June 17, 2022
Cardiovascular / Cardiology
Cardio Flow, Inc., Announces FDA Clearance for FreedomFlow® Peripheral Guidewire, and their First Commercial Case Completed in U.S.
Cardio Flow, Inc., a medical device company and developer of minimally invasive peripheral vascular devices to treat peripheral artery disease (PAD), announced it recently received U.S. Food and Drug Administration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire. The FreedomFlow...
June 7, 2022
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