Heartflow Holding Inc. is aiming to bring its noninvasive, artificial intelligence (AI)-based test for coronary heart disease to more doctors and patients via a merger with Longview Acquisition Corp. II. The deal, valued at an enterprise value of about $2.4 billion, is the latest in a steady stream of med techs queueing up to go public via a “blank check” special purpose acquisition company (SPAC) this year.
Approval could come next year for Furoscix from Scpharmaceuticals Inc. (Scpharma), a solution of the standard-of-care heart failure diuretic furosemide formulated to a neutral pH and designed for outpatient use.
A large health system in Minnesota recently became the first in the world to have completed a structural heart procedure, or any other surgical procedure for that matter, using any kind of 4D hologram technology. The technology was developed by venture capital-backed startup Echopixel Inc., and it is intended to improve both surgical precision and outcomes in minimally invasive procedures.
Neuro- and peripheral-vascular interventional med-tech developer Zylox-Tonbridge Medical Technology Co. Ltd. raised HK$2.56 billion (US$329 million) in Hong Kong on July 5 via an IPO that will support the development and commercialization of its core products.
Tioga Medical Inc. closed a $30 million series B financing led by The Capital Partnership (TCP), with participation from Cormorant Asset Management, Amed Ventures and Shifamed angel investors. The financing will be used to advance product development, support preclinical testing, and initiate clinical experience for the company's transcatheter mitral valve replacement technology.
Surmodics Inc. has acquired Vetex Medical Ltd., a Galway, Ireland-based company focused on venous clot removal, for $39.9 million. The move gives Surmodics a second FDA-cleared mechanical thrombectomy device, Revene, to treat venous vasculature, adding to its Pounce arterial thrombus retrieval system. Founded in 2016, privately held Vetex’s sole product is the Revene thrombectomy catheter. The device received FDA clearance in December 2020 and CE mark approval in May for the mechanical declotting and controlled and selected infusion of physician-specified fluids, including thrombolytics – clot-busting drugs – in the peripheral vasculature.
PERTH, Australia – With FDA approval of its Guardian system to detect early heart attacks, Angel Medical Systems Inc. (Angelmed) will launch the device in the next six weeks in the U.S., and partner Hydrix Ltd. will launch the devices in eight Asia Pacific markets.
An artificial intelligence (AI)-powered tool invented by researchers from a trio of Singaporean institutions could speed up the diagnosis of cardiovascular diseases. The innovation uses electrocardiograms (ECGs) to diagnose coronary artery disease, myocardial infarction and congestive heart failure.
Medtronic plc kicked off an app-based research study to improve understanding of atrial fibrillation (AF) disease burden and its impact on patient outcomes, quality of life and health care utilization. The first patients in the DEFINE AFib study were enrolled at Duke University Medical Center and the Florida Electrophysiology Associates in Atlantis, Fla. “When it comes to managing atrial fibrillation, there is not a ‘one-size-fits-all’ approach, and the hope is that DEFINE AFib may give us the tools to help personalize AF management based on a patient’s individual health profile and physiology,” said Jonathan Paul Piccini, director of cardiac electrophysiology and associate professor of medicine at Duke University School of Medicine and chair of the DEFINE AFib Steering Committee. “DEFINE AF will harness the power of digital health to make fundamental discoveries about how we can manage atrial fibrillation better in each and every one of our patients.”
While stakeholders have concerns about the costs of registries for medical devices, they are still generally seen as less expensive and simpler to administer than randomized, controlled clinical trials (RCTs). A new journal article compares the quality of the data from a registry and the data generated by a clinical trial, and despite an interest in ascertaining whether registry data provided similar data quality, the authors concluded that registry data is still more useful as a means of supporting, rather than supplanting, the RCT.