Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Berlin Heart, Canam Scientific, Clordisys Solutions, Sd Biosensor, Zymo Research.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Alafair Biosciences, Barm Advanced Communications, Bioventus, Certara, Ibex Medical Analytics, Integrated DNA Technologies, Iridex, Ligolab, Merit Medical Systems, Mevion Medical Systems, Microbix Biosystems, Mission Bio, MVP Health Care, Nemaura Medical, Perflow Medical, Persephone Biosciences, Proscia, Rhinostics, Roche, Shanghai Focus Healthcare, Swift Biosciences, Teleflex.
LONDON – The largest study of its kind to date has identified new biomarkers of inflammation that are both indicators of severe COVID-19 infection and distinguish it from severe influenza.
MIT Media Labs spinoff Empatica Inc. secured the CE mark for its Aura system, a wearable solution for the monitoring and early alert of respiratory infections, including COVID-19. For use with people 14 and older, Aura is commercially available in Europe and the U.K., and for pilot purposes in the U.S. – pending FDA authorization. Aura’s algorithm analyzes vital signs from Empatica smartwatches, comparing data against the wearer’s historical baselines. In validation studies, Aura was able to detect patients with possible H1N1 influenza, rhinovirus or SARS-CoV-2 infection with 0.94 sensitivity. Detection occurred on average two days after infection.
In 2020, the Conference on Retroviruses and Opportunistic Infections (CROI) was the first medical conference to go virtual, with two days advance warning, when news of infections resulting from a Biogen Inc. conference with about 150 attendees made it abundantly clear that SARS-CoV-2 was circulating, well, probably everywhere.
DUBLIN – Grifols SA is acquiring Gigagen Inc. outright by paying $80 million for the remaining 56% of the company’s equity it does not already own. Its total outlay comes to $115 million, as it had previously acquired a 35% stake in South San Francisco-based Gigagen back in 2017.
Cue Health Inc. became the first company to offer COVID-19 molecular testing for home use without a prescription following U.S. FDA emergency use authorization on March 5, 2021. The San Diego-based company’s isothermal nucleic acid amplification test (NAAT) detects RNA from SARS-CoV-2 virus present in the nostrils. “The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at-home, without a prescription.”
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptive Biotechnologies, Cochlear, Ortho Clinical Diagnostics, Promaxo, Siemens Healthineers.
