Shockwave Medical Inc. will acquire Neovasc Inc. for just under $108 million, if all terms of the deal are met. Shockwave will pay $27.25 in cash for each of Neovasc’s 2.71 million outstanding shares or approximately $73.78 million at close. Shockwave said the offer corresponds to an enterprise value of $100 million. Neovasc could receive an additional payment of up to $47 million, if the company’s Reducer system for refractory angina obtains U.S. FDA marketing approval within a specified time frame. Read More
The European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) each allow a hospital to develop a device or an in vitro diagnostic for use solely in that hospital, but there is no regulatory free pass despite the lack of commercial intent. While the latest guidance on these in-house tests acknowledges that the hospital must determine the degree to which it must comply with the relevant regulation, any hospital that makes and uses an in-house diagnostic or device must develop a risk management mechanism for that device or diagnostic, not an easy lift for entities that may be glancingly familiar at best with conventional regulatory schemes. Read More
Nervtex Co. Ltd.’s diagnostic assessment software Modas for movement disorders such as Parkinson’s disease has been given NMPA approval in China. Using smart mobile devices, Modas can process video data collected from people with potential or existing movement disorders when they are in any specific motion state. Read More
Urgo Group SAS has launched, in the presence of the Minister of Health François Braun, the creation of Genesis research laboratory on artificial skin. “Our objective with this novel tissue engineering laboratory is to create artificial skin for helping the health care professionals in the effective treatment of severe wounds and quickly curing the patients,” Guirec Le Lous, CEO of Paris-based Urgo Medical, told BioWorld. Urgo Medical is the advance wound care division of Urgo Group SAS. Read More
In what is claimed as the largest study of how digital technologies were applied to support population level research during the pandemic, scientists at the U.K. Medical Research Council’s epidemiology unit at Cambridge University have reported high, sustained levels of engagement in a fully remote COVID-19 study that ran at a time when visits to a study center were not possible. Read More
New hires and promotions in the med-tech industry, including: Cytosorbents, Immunovia, Luseed Vascular, Perimeter Medical Imaging AI, Ra Medical Systems, Tissium, Turbett Surgical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alithea Genomics, Asahi Kasei, Genetik, Ginkgo Bioworks, Medicines Discovery Catapult, Minxray, Pamgene, Seno Medical Instruments, Smi Drug Discovery, Theralink, Xwell, Zoll. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott. Read More
