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The U.S. FDA has granted breakthrough device designation to Tempus Inc. for its ECG Analysis Platform. Developed in collaboration with Geisinger, the artificial intelligence (AI)-powered platform helps clinicians identify patients at increased risk of developing atrial fibrillation (AF) or atrial flutter.
TORONTO – Hemocath Ltd. is gearing up for a first-in-human trial of a device that addresses two critical metrics for the treatment of heart failure: pulmonary artery and central venous pressure. Hemocath’s pulmonary artery catheter (PAC) is part of a larger heart failure monitoring platform and is intended to assess fluid status in patients with severe or worsening congestive heart failure. The hope is to replace larger, more invasive catheters inserted into a patient’s neck.
Keeping you up to date on recent developments in cardiology, including: Translational medicine slow to change cardiovascular care; New study results boost case for BASILICA; Mitral repair still worthwhile despite issues with atrial fibrillation.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants de novo for Biofire multianalyte assay; No injuries or deaths associated with Acist Kodama recall; Supreme Court to hear assignor estoppel case; Cardiac rehab bill resurfaces in U.S. House.
PARIS – Carmat SA has just completed a capital increase of $66.4 million to boost development of its total artificial heart. The Aeson system was awarded CE marking four months ago, as a total bridge to transplantation for patients suffering with end-stage biventricular heart failure who are not eligible for maximal medical therapy or a left ventricular assist device (LVAD), and who are likely to undergo a heart transplant within 180 days of the implantation.
Keeping you up to date on recent developments in cardiology, including: Lack of ‘moral compass’ cited as driver of increase in atherectomy in PVI; Study links hypertension to atrial fibrillation; Machine learning of limited value in predicting in-hospital AMI death.
Neuroclear Technologies Inc., a subsidiary of Biosig Technologies Inc. formed to focus on the emerging field of bioelectronics, was allowed a utility patent by the U.S. Patent Office that the company exclusively licensed from Mayo Foundation for Medical Education and Research. Neuroclear aims to use neurostimulation technology to develop novel solutions to challenging physiological and neurological disorders. The company's first target and the focus of the patent is treatment of hypertension via electroporation of renal nerves.
Corvista Health Inc., a subsidiary of Toronto-based Analytics for Life Inc., reported closing on $65 million in series C equity financing, bringing total cash raised for a new cardiac diagnostics device to nearly $100 million. The Corvista system is described as noninvasive, point-of-care diagnostic system for coronary artery and other cardiovascular diseases.
Less than six years after acquiring Cordis Corp. from Johnson & Johnson, Cardinal Health Inc. is selling the troubled cardiovascular device manufacturer to private equity firm Hellman & Friedman LLC for roughly $1 billion. Shares of the medical products and drugs distributor (NYSE:CAH) were up 2.93% to $57.35 at close on Friday.
Medi-Scan Inc. has emerged from stealth mode with cloud-based software that converts the data on ultrasound analog 2D grayscale images into a digital 3D high-definition (HD) format in less than two minutes. The company is currently focusing its efforts on the heart and lungs, with the aim of providing quick, point-of-service evaluation and triaging of patients with heart disease and other conditions, including COVID-19.
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