Boston Scientific Corp. has agreed to acquire Preventice Solutions Inc. for $925 million up front and up to an additional $300 million in a potential commercial milestone payment. The former has been an investor in Preventice since 2015 and currently holds an equity stake of about 22%, which is expected to result in a net payment of about $720 million upon closing and a milestone payment of up to roughly $230 million. The acquisition is projected to close by the middle of the year. Read More
Medtronic plc is looking to increase market share in pain stimulation with its differential target multiplexed (DTM) therapy, a recharge-free device and its next big disrupter, evoked compound action potential (ECAP). The company is currently developing a closed-loop SCS system for chronic pain following failed back surgery based on ECAP and DTM algorithms. Read More
The implementation date for the European Union’s In Vitro Diagnostic Regulation (IVDR) is a mere 16 months away, although there is widespread interest in a delayed implementation date. Nonetheless, Warren Jameson, principal regulatory consultant for North American Science Associates (NAMSA) of Toledo, Ohio, urged test makers to conduct a gap analysis of the conformity of their currently marketed tests to the new regulations because a large percentage of the underlying dossiers would not pass muster under the terms of the new regulatory regime. Read More
New funding to the tune of $8 million in series B investment moves Oncohost Ltd. a good bit closer to bringing its personalized immunotherapy prediction platform to market and key operations to the U.S. Ourcrowd, an investment platform that simplifies investment by accredited investors and others in startups, early-stage companies and venture funds, led the round. Other participants included a group of family offices and private investors. Read More
One of the side effects of COVID-19 is the acceleration of a shift in health care delivery that is changing how drug and device companies market their products to doctors. There’s no going back to the commercial model where having a sales rep call on a doctor was the way to market a product, Rita Numerof, CEO and co-founder of Numerof & Associates, said during a Jan. 21 webinar on the impact the pandemic has had on drug and device detailing. Read More
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Seoul-based Vuno Inc.’s artificial intelligence (AI)-based solution Vuno Med Deepbrain for use as a class III medical device, which is a classification for moderate risk level devices. The MFDS approval was given on Dec. 29, 2021, a Vuno spokesperson told BioWorld, but the company only disclosed the approval earlier in the week. The reasons for the delayed announcement were not disclosed. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aiforia, Atc Alert, Berkshire Biomedical, Biotheranostics, Brain Scientific, Bruker, Cairnsurgical, Canadian Hospital Specialties, Carenity, Cerba Research, Echosens, Electrocore, Erba Mannheim, Fortress Medical Systems, Helix, Imbiotechnologies, Inivata, Natera, Numares, Orasure, Pathan, Polarityte, Premier Medical Laboratory Services, Qiagen, Thomas Scientific, Viveve, Xclinical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Canon Medical Systems, Covaxx, Lumiradx, Retia Medical, Zimmer Biomet. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Hahn out, Woodcock in as acting FDA commissioner; White House orders regulatory freeze. Read More
Keeping you up to date on recent developments in diagnostics, including: Increasing COVID-19 detection through secondary distribution of self-tests; COVID-19 and breath analysis; Saving lives from colorectal cancer; New classification scheme for glioblastomas. Read More
