Abiomed Inc. has won the U.S. FDA’s nod for its Breethe Oxy-1 device, an all-in-one, compact cardiopulmonary bypass system designed for easy mobility. The company plans a controlled release at U.S. hospitals between now and March of 2021, with widespread availability later that year. Read More
Premarket approval by the U.S. FDA of a new venous stent system made by Medtronic plc could blast through impediments for patients who suffer from complex deep vein obstruction. Less than 1% of patients with iliofemoral venous outflow obstruction currently receive treatment, despite the risk of serious complications and sharply reduced quality of life. Approval of the Abre stent was based on a 200-patient clinical study. Read More
Day Zero Diagnostics Inc. has reported that data presented at IDWeek highlighted the promise of the company’s new class of diagnostics as it works toward its goal of detecting superbug infections quickly. The company ultimately is hoping to get regulatory signoffs in both the U.S. and Europe for its technology. Read More
The U.S. FDA draft guidance for select updates for premarket evaluation of class II atherectomy devices arrived with a lack of clarity that prompted device makers and clinicians alike to request the FDA address several sources of ambiguity. One of these is whether the agency should distinguish between particulate matter from the device vs. calcium particulates from the treated artery, while another is whether particulate evaluation is required only for devices with a coating. Read More
PARIS – Carthera SAS, of Paris, has obtained a $2.4 million grant and $12.5 million equity investment from the European Innovation Council (EIC) for the development of its ultrasound-based medical device for treating glioblastoma. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Medtronic advises of problems with Interstim leads; Palmetto eyes coverage of CT for cerebral perfusion. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biolife Sciences, Epicgenetics, Hologic, Medtronic, Mindray North America, Precision Nanosystems, Sectra Epicgenetics, Sensyne Health, Sqi Diagnostics, Tegra Medical, Titan Medical, Truvian Sciences. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abiomed, Bio-Techne, Foldax, Foundation Medicine, Helix, Kantaro, Perkinelmer, Siemens Healthineers, Theranica. Read More
Keeping you up to date on recent developments in cardiology, including: Monitoring the hearts of breast cancer patients; Cardiamp demonstrates improvement in heart failure patients; Weight-reduction surgery in severely obese patients could ward off second heart attack. Read More
