Medtronic plc obtained the CE mark for its Sensight directional lead system for deep brain stimulation (DBS) for movement disorders and epilepsy, which is designed to be used with the company’s Percept PC DBS device. Percept received U.S. FDA clearance in June 2020 and CE mark in January 2020. Read More
The COVID-19 pandemic has affected wide swaths of the global economy, mostly in a negative manner, but it has spurred some types of innovation at a rate that would be unimaginable in ordinary times. That seems to be the take-away for an emergency use authorization (EUA) granted to Miami-based Tiger Tech Solutions Inc. for its COVID Plus monitor, which uses plethysmography and a machine learning algorithm to provide a screening mechanism at mass gatherings, thus bringing the world one step closer to a state of normalcy. Read More
PERTH, Australia – With a fresh injection of A$28.9 million (US$22.4 million) in grant funding from the Australian government and a capital raise of A$40 million, 4dmedical Ltd. is well on its way to commercializing its first lung imaging product in the U.S. and Australia. 4dmedical’s X-ray velocimetry (XV) technology is the first FDA-cleared respiratory imaging solution that uses mathematical models and algorithms to convert sequences of X-ray images into four-dimensional quantitative data. Read More
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. Read More
PARIS – Whitelab Genomics SAS has signed a partnership agreement with Genethon, a French research center in the field of gene therapy, to ramp up development of genetic therapy techniques using artificial intelligence (AI). As part of this partnership, Genethon will use the Whitelab Genomics Catalyst platform to develop new capsids. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 7D Surgical, Biocorp Production, Cardiovascular Systems, Diabeloop, Genesis Medtech, Health Logic Interactive, Innotech Precision Medicine, Seaspine, Shockwave Medical, Wavepoint Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Recovery Force. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG hits Mississippi hospital for polysomnography claims; BD expands Chloraprep recall to all 50 states. Read More
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. Read More
