Cardio Diagnostics Holdings Inc to Debut PrecisionCHD™ at the American College of Cardiology’s 72nd Annual Scientific Session

Cardio Diagnostics Holdings Inc (Nasdaq: CDIO), an artificial intelligence-powered precision cardiovascular medicine company, today announced that its newest coronary heart disease test, PrecisionCHD™, will be presented at the American College of Cardiology’s 72nd Annual Scientific Session (ACC.23), taking place in New Orleans, LA, from March 4-6, 2023. PrecisionCHD, the company’s coronary heart disease early detection…

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TIOGA CARDIOVASCULAR, A SHIFAMED PORTFOLIO COMPANY, CLOSES $30M IN SERIES C FINANCING

Tioga Cardiovascular, a Shifamed portfolio company that aims to redefine structural heart valve replacement, announced today the first closing of its $30M Series C financing. Led by Cormorant Asset Management, with significant participation from The Capital Partnership, AMED Ventures, the PA MedTech VC Fund, and Shifamed angel investors, the financing will be used to continue…

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Lydus Medical Announces FDA Clearance of Vesseal™, The Microvascular Anastomosis Aid Device for Small Arteries

Lydus Medical is pleased to announce that the Vesseal™ has received FDA clearance 510(k). The Vesseal™ is a microvascular anastomosis suture deployment system, for standardized omni-vessel anastomoses, enabling simple, fast, safe, and effective procedures. An anastomosis is one of the most complicated steps of microvascular surgery and fundamental to the success of these demanding surgical interventions. Varied clinical…

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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 RDL is the newest addition to Imperative Care’s Zoom Stroke Solution™, the company’s ischemic stroke…

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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 2023 submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. If FDA…

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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 smart ring’s blood oxygen saturation (SpO2) and heart rate data. In comparing the overall accuracy…

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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 generation control unit for its flagship product, IRRAflow, the world’s first and only active fluid…

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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 level and ethnicity. The results come from analysis of the pooled data from ReCor’s RADIANCE…

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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. Food and Drug Administration. The device monitors and detects endovascular bleed complications through a novel…

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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 through a tender offer all outstanding shares of Abiomed, for an upfront payment of $380.00…

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