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.
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.
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.
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.
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.
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.
A green light from the U.S. FDA has significantly brightened Seno Medical Instruments Inc.’s image of its immediate future. The San Antonio-based company developed a novel breast cancer imaging technology that combines noninvasive opto-acoustic (OA) technology with ultrasound (US) to more accurately distinguish benign from malignant breast lesions following ambiguous mammography results.
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