LONDON – The largest study to date, involving 236,379 confirmed cases, shows that 1 in 3 survivors of COVID-19 was diagnosed with a neurological or psychiatric condition within six months of contracting the infection. For 13% of those patients, it was their first such diagnosis.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA hits company for deviations from drug, device GMPs; Stryker undertakes correction for AEDs; MHRA: Creams, ointments may interfere with CGM function; NICE says liver perfusion suffers for want of evidence of efficacy; NIAID testing vaccine allergy hypothesis; EC provides emergency funding for COVID-19 research; Medtronic splits Ninth Appeals’ review of lower court decision; Industry, docs push back on prior authorization.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Chemence Medical, Nuvasive, Vitro Biopharma.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied DNA Sciences, Astrotech, Atai Life Sciences, Breathtech, Johnson & Johnson Vision, Manta, Medical Information Technology, Menicon, Natera, Newomics, Nicoya Lifesciences, Opsens, Psyber, Premier Medical, Qiagen, Roche, Titan Health & Security Technologies, Vizient.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acarix, Akili Interactive, Boston Scientific, Cardiac Dimensions, Lumithera, Medcura, Pixium Vision, Protokinetix.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA adds fingerstick sample to roster of COVID EUAs; NICE: Sonata system not backed by head-to-head studies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Philips, Roche.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcam, Avacta, Applied Spectral Imaging, Biotome, Brainchip, Critical Transport Solutions Australia, Cryoport, Eurofins Viacor, Heartflow, Kromatid, Masimo, Motus GI, Novel Microdevices, Oncimmune, Ortho Regenerative Technologies, Roche.
The European Commission opened a public consultation to help it develop the Health Emergency Preparedness and Response Authority, a new initiative to better prepare Europe for cross-border health threats.