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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lightpoint Medical, Omniguide Holdings, Renegade.bio.
PERTH, Australia – The majority of medical device and biopharma industry respondents agreed that Australia’s Therapeutic Goods Administration (TGA) responded effectively to COVID-19, but they want to see the agency improve its processes to act faster and with more clarity, according to the TGA’s annual stakeholder survey.
The U.S. FDA notice regarding device risk classification proposes to eliminate premarket notification requirements for several device types, a welcome development for industry. However, Amanda Johnston, senior attorney at Gardner Law PLLC, of Stillwater, Minn., told BioWorld that there is a question regarding the provenance of the document, as it fails to identify any FDA staff member. In addition, the notice omits several device types that are solid candidates for down-classification.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Motus GI, Sml Genetree.