The COVID-19 pandemic has affected the U.S. FDA on the postmarket side as well as on the premarket side, but the focus of pandemic-driven warning letters has shifted over time. Amanda Johnston, senior attorney at Gardner Law of Stillwater, Minn., said on a Nov. 5 webinar the FDA’s emphasis lately has been closer to the agency’s traditional enforcement considerations after an initial wave of warnings dealing with flatly fraudulent products.
Becton, Dickinson and Co. (BD) reported good news Thursday, as it saw quarterly revenues of $4.784 billion for its fourth fiscal quarter, an increase of 4.4% over the prior-year period. Of note, the company’s life sciences segment saw worldwide revenues of $1.488 billion, representing an increase of 31.2% over the prior-year period as reported, or 31.4% on a currency-neutral basis.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3D Systems, Avinger, Eurofins Scientific, Oxford Immunotec, Pear Therapeutics, Sectra, Veracyte.
The U.S. FDA’s stated policy is that it will not review emergency use authorizations (EUAs) for lab-developed tests (LDTs) for the COVID-19 pandemic, but that doesn’t mean labs are completely shut out. The FDA’s Toby Lowe said that a lab that wants to pair an assay that already has an EUA with a new software installation on lab instrumentation can work with the assay developer to update that EUA.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied UV, Axsome Therapeutics, Clinical Laserthermia Systems, Digirad, Electromedical Technologies, Energetic Wellness School of Naturopathy, The Feinstein Institutes for Medical Research, Mimedx, Novan, Ontrak, Stryker, Thermo Fisher Scientific, Toyoda Gosei, Wright Medical Group.
Keeping you up to date on recent developments in orthopedics, including: New opportunities for detecting osteoporosis; Brazilian researchers discover how muscle regenerates after exercise; Different outcomes by race/ethnicity among patients with COVID-19 and rheumatic disease.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA announces recall of discontinued Medtronic catheter.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Biolytical Laboratories, DNA Genotek, Pari Pharma, Salvia Bioelectronics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alveo Technologies, Biocartis Group, Coloplast, Decision Diagnostics, DJO Global, Endpoint Health, Geneprodx, Hutchinson Technology, Joline, Mir Scientific, Morton Comprehensive Health Services, Motus GI, Nine Continents Medical, Novarad, Ossdsign, Oxford Gene Technology, Remark Holdings, Resonetics, Sirakoss, Stryker, Wright Medical Group.
RSS
