Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Genalyte.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Altrix Medical, Chembio Diagnostics, Eurofins Biomnis, Jud Care, Luxfer, Myriad Genetics, Neurox, Nexgel, Stratus, Transforming Systems, Ursa Health, Vitalhub.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA posts guidance agenda for FY 2021; Third-party 510(k) review report posted; NIOSH testing flunks more imported filter masks; OIG says Cedars-Sinai billed for non-compliant bariatric surgeries.
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Anges, Aslan, Beyond Air, Er-kim, ICER, Macrogenics, Omeros, Takeda.
Although the volume of med-tech deals and mergers and acquisitions in 2020 rival each of the last two years, the level of disclosed values has fallen far short of 2019 in both instances.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Added Value Business and Marketing Solutions, Boehringer Ingelheim, Bioaffinity, Biovo Technologies, Blackstone Medical Services, Cardiac Safety Research Consortium, Fujifilm Medical Systems U.S.A., IDbyDNA , Illumina, IT-IS International, Jaya Unggul Gemilang, Konica Minolta, Mevion, Novacyt, Nupaf, Olim Het, Philips, Precision Pathology Services, Scriptsender, Smiths Medical, Summit, Trekstor, Victory Square, Volpara Solutions.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Federal Circuit declines to overturn lower court ruling for Medtronic; FDA stands pat on biotin interference threshold in final guidance; CMS adds to telehealth list.
“It’s coming. We know it’s coming.” That was Nevan Krogan’s blunt reminder that SARS-CoV-2 is not the first virus to wreak temporary havoc on humanity, nor will it be the last.