Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, Boston Scientific, Envoy Medical, Orthofix.
Keeping you up to date on recent developments in cardiology, including: COVID-19 an independent risk factor for acute ischemic stroke; New heart valve holds hope for open heart surgery; Company unveils results on therapy to treat cardiovalvular diseases.
The U.S. FDA’s response to the COVID-19 pandemic may have got off to a rocky start, but the agency’s device center has changed course rather quickly several times in recent months. Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the latest COVID-19 town hall that the push is now on several relatively novel points of emphasis, including high-throughput testing, a technology that may prove critical to corralling the SARS-CoV-2 virus when flu season arrives later this year.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Babson Diagnostics, Circadia Health, Ekso Bionics, Medtronic, Nyxoah, Viraxclear.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 1Health.io, Cylera, Dentsply Sirona, Ebb Therapeutics, Edge Endo, Global Wholehealth Partners, Hamilton Health, Hi-Clearance, Joimax, Labcorp, Neovasc, Pharmaceutical Product Development, Pri·Med Medical Products, Royal Philips, Physiq, Sequana Medical, Sleepscore Labs, Stevanato Group, The Abedgraham Group, US Endodontics.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbott, Dayzz, Elixir Medical, InspireMD, Medtronic, Sintx Technologies.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avacta Group, Biocept, Caremindr, Cortechs, Cytiva, Docbot, Erba Mannheim, Fluidigm, Global Wholehealth Partners, Incontext.ai, Integrated Genetics, Life Image, PCORI, RapidAI, Senzime, Smiths Medical, Subtle Medical, Sugarmate, Tandem Diabetes Care, Windtree Therapeutics.
Adarza Biosystems Inc.’s Ziva platform can simultaneously detect hundreds of proteins, antibodies, or substrates from a single drop of blood, plasma or serum, providing insight into an individual’s immune response. That could be critical for both surveillance and diagnostic purposes as the nation prepares for a likely second wave of the novel coronavirus in the fall when multiple respiratory pathogens will be circulating.
