medical device guru

Cardiovascular / Cardiology
Recor Medical and Otsuka Medical Devices Announce Positive Vote from the FDA Advisory Committee Meeting on the Paradise™ Ultrasound Renal Denervation System
Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) announce the U.S. Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application...
August 23, 2023
Cardiovascular / Cardiology
Acorai receives Breakthrough Device Designation for their Non-Invasive Intracardiac Pressure Monitor
Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Acorai’s Heart Monitor, a device for the non-invasive estimation of diastolic pulmonary artery pressure (dPAP), systolic pulmonary...
August 10, 2023
Cardiovascular / Cardiology
Capstan Medical Leverages Robotics to Bring Minimally Invasive Care to Heart Valve Patients
Capstan Medical, a developer of minimally invasive technology to address heart valve disease, today announced an oversubscribed $31.4 million Series B investment led by Eclipse. Additional participating investors include Intuitive Ventures and Puma Venture Capital, a new firm founded by Amit Hazan, a...
August 9, 2023
Cardiovascular / Cardiology
FDA Grants Clearance for UltraSight’s AI-Powered Cardiac Ultrasound Technology
UltraSight, a digital health pioneer transforming cardiac imaging through the power of artificial intelligence, announced that it has been granted FDA clearance for its AI-powered ultrasound guidance technology. The UltraSight real-time AI guidance software can assist medical professionals without sonography...
July 27, 2023
Cardiovascular / Cardiology
FDA Clears Numares Health Cardiovascular Diagnostic Test and Core Technology Platform
The US Food and Drug Administration has cleared a Numares Health test, the AXINON® LDL-p Test System, as a new tool physicians can use to measure lipoproteins for patients at risk for cardiovascular disease. Currently, Numares is the only company...
July 25, 2023
Cardiovascular / Cardiology
AccurKardia’s AccurECG™ Analysis System Receives FDA 510(k) Clearance
AccurKardia, a medical technology company delivering clinical-grade ECG interpretation software, announced today that its flagship product, the AccurECG™ Analysis System (“AccurECG” or the “System”), has been granted FDA 510(k) clearance. AccurECG™ is a cloud-based, device-agnostic and fully automated electrocardiogram (ECG) interpretation software...
July 12, 2023
Cardiovascular / Cardiology
FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc.
The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with...
June 19, 2023
Cardiovascular / Cardiology
Innova Vascular Earns FDA Clearance for Two New Thrombectomy Devices: Laguna Clot Retriever™ System and Malibu Aspiration Catheter™ System
Innova Vascular, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Laguna Clot Retriever™ System and its Malibu Aspiration Catheter™ System for use in the peripheral vasculature. The two new devices are collectively known...
June 7, 2023
Cardiovascular / Cardiology
PaceMate Announces Collaboration with AliveCor to Offer Cutting-Edge Remote Monitoring Platform
PaceMate® announced today its collaboration with AliveCor®, the global leader in FDA-cleared personal electrocardiogram technology and remote patient management solutions for the cardiovascular industry. This collaboration will combine the strengths of PaceMate’s world-class cardiac remote monitoring platform, PaceMateLIVE™ – designed to...
May 19, 2023
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