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Cardiovascular / Cardiology

Inspira™ Announces 510(k) FDA Submission of INSPIRA™ ART100 Towards Commercialization

Inspira™ Technologies OXY BHN Ltd. (Nasdaq: IINN, IINNW) (the “Company” or “Inspira Technologies”), a company aiming to bring a paradigm shift to acute respiratory care by empowering breathing without lungs, announced it had submitted its INSPIRA ART 100, a cardio-pulmonary bypass device,...

September 13, 2023

Cardiovascular / Cardiology

FDA Approves LimFlow System in Patients With Chronic Limb-Threatening Ischemia and No Suitable Endovascular or Surgical Revascularization Options

LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved the LimFlow...

September 12, 2023

Cardiovascular / Cardiology

Aquedeon Medical, Inc. Receives FDA IDE Approval for the Duett Vascular Graft System

Aquedeon Medical, Inc., a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its...

September 8, 2023

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