Cureapp Inc. is ready to take the next step for its digital therapeutic app (DTA) for hypertension, after completing a late-stage clinical trial and publishing the results. The company said it is the first global trial for a therapeutic app, conducted to seek regulatory approval in the field of hypertension.
Nectero Medical Inc. has secured $19.5 million in a series C financing round, led by Boston Scientific Corp. The company is developing the Endovascular Aortic Stabilization Treatment (EAST) system, a treatment platform that reduces the growth rate of aortic aneurysms. EAST is currently in a multisite phase I safety study for abdominal aortic aneurysm (AAA) patients and the financing will be used to fund further in vivo and clinical development.
Robotic technologies company Stereotaxis Inc. is scaling up its footprint in the Chinese med-tech market, with a deal to commercialize its robotic technology for heart rhythm therapy in China with Shanghai Microport EP Medtech Co. Ltd. The St. Louis-based Stereotaxis aims to introduce a second-generation robot called Genesis to the Chinese market that uses a magnetic navigation technology to treat heart rhythm disorders. Its partner, Shanghai Microport EP Medtech, is a division of one of China's largest med-tech manufacturers, Shanghai-based Microport Scientific Corp.
Abbott Laboratories, has acquired Walk Vascular LLC, a deal that brings two devices for peripheral thrombectomy to the Abbott portfolio for peripheral artery disease (PAD). Walk’s two Jeti peripheral thrombectomy devices are cleared in the U.S. for break-up and removal of soft emboli and thrombus, but are in trial for deep-vein thrombosis (DVT) as well, suggesting that Abbott Park, Ill.-based Abbott has availed itself of a technology that could take a big bite out of one of the deadliest and costliest of all circulatory system pathologies.
The race is on. After six years as the only FDA approved devices for left atrial appendage closure, Boston Scientific Corp.’s Watchman products face a challenger, Abbott Laboratories’ Amplatzer Amulet. With the Amulet’s FDA approval in mid-August and positive results in a head-to-head trial presented at the 2021 European Society of Cardiology Congress on Tuesday, the Watchman has reason to look over its shoulder at a competitor that could change the game entirely. The trial results were published simultaneously in Circulation.
Vuno Inc. received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for Vuno Med Deepcars, its artificial intelligence (AI) medical device for cardiac arrest prediction. Approval in hand, Seoul-based Vuno will push for wider adoption of its biosignal-based AI technology. Vuno Med Deepcars predicts the probability of cardiac arrest occurring within a 24-hour period by analyzing a patient’s pulse, respiratory rate, diastolic and systolic blood pressure as well as body temperature. The data is collected from the electronic medical record of hospitalized patients.
PERTH, Australia – Cardiovascular medical device company Venstramedical Ltd. has raised $2 million in seed funding to support development of a small catheter-inserted collapsible heart pump. The Sydney-based company is aiming to develop devices that provide cardiac support for failing hearts without the use of surgery, Venstramedical co-founder and CEO Martin Cook told BioWorld.
The FDA has approved Medtronic plc’s Evolut FX TAVR system for patients with symptomatic severe aortic stenosis. During Medtronic’s fiscal first quarter earnings call CEO Geoffrey Martha said the company will roll the latest generation system out in the U.S. market later this year, with a full launch planned in 2022.
PARIS – The High Authority for Health (HAS) in France recently published a 165-page report on use over 10 years of long term mechanical circulatory assist devices (MCS). HAS conducted this wide-ranging study to review the conditions for the management of MCS devices, technology that has been constantly evolving over the past decade.
Shanghai Heartcare Medical Technology Co. Ltd. shares took a hard fall in their Aug. 20 debut on the Hong Kong Stock Exchange (HKSE), closing at HK$129 (US$107.47) after tumbling all the way down to HK$127.8 earlier in the day.