PERTH, Australia – The Australian government’s Medical Research Future Fund (MRFF) has funded a new program called the Artificial Heart Frontiers Program that aims to develop and commercialize a world-first durable total artificial heart. The Medical Research Future Fund has provided A$1 million (US$739,000) in funding that will establish the program over the next five years.
Microport Scientific Corp.’s cardiac rhythm disorders subsidiary, Microport Cardiac Rhythm Management Ltd. (Microport CRM), has confirmed agreements for a series C financing that would net it total investment proceeds of $150 million. Hillhouse Capital Group and Microport will co-lead the series C investment with investments of $20 million and $47 million, respectively.
Abbott Laboratories has secured FDA clearance for its latest optical coherence tomography (OCT) imaging platform powered by the company’s new Ultreon software. The artificial intelligence (AI)-powered imaging software allows doctors to view coronary blood flow and blockages more clearly, aiding in care management and treatment decisions.
Biofourmis Inc. won a breakthrough devices nod from the FDA for its Biovitalshf solution, a digital therapeutic for patients with heart failure with reduced ejection fraction (HFrEF). The company, which is pursuing the de novo pathway for the therapy, plans to launch a pivotal trial next month. Biovitalshf is intended to augment guideline-directed use of heart failure medications to manage patients in combination with traditional pharmacotherapy. The software application integrates physiological monitoring, symptoms and signs reporting, patient engagement, medication management and communications to provide clinicians with personalized and specific recommendations about their medication.
Medtronic plc got a thumbs up from the FDA for two Accurhythm algorithms to detect atrial fibrillation and asystole in patients who have heart rhythm abnormalities. The new artificial intelligence (AI)-based algorithms are designed for use on the company’s Linq II insertable cardiac monitor (ICM). Dublin-based Medtronic said the Accurhythm AI algorithms will be available on its Carelink Network later this year for use with all implanted Linq II devices in the U.S.
Medtronic plc launched the newest product in its coronary portfolio, the Prevail drug-coated balloon (DCB) catheter, in Europe following CE mark approval. The device is intended for use during minimally invasive procedures to open narrowed or clogged arteries in patients with coronary artery disease.
PARIS – Royal Philips NV is working with the Spanish National Center for Cardiovascular Research (CNIC) on an ultrafast cardiac magnetic resonance imaging (MRI) protocol that could reduce scanning times to just a few minutes.
Vivasure Medical Ltd. has designed a sutureless and absorbable venous vessel closure for use following percutaneous cardiovascular procedures, such as transcatheter mitral valve or tricuspid valve repair or replacement. The Perqseal Blue technology builds on the Galway, Ireland-based company’s Perqseal, which received the CE mark for vascular closure of femoral arteries in 2016.
The FDA granted breakthrough device designation to Royal Philips NV for its laser-assisted inferior vena cava (IVC) filter removal device. The Amsterdam-based company designed the device to ablate tissue for removing an IVC filter when previous methods of removal have already failed.
The U.K. National Institute for Health and Care Excellence (NICE) said devices used to repair paravalvular leak around replaced mitral or aortic valves should only be used in studies because of a limited set of data on efficacy.