The problem with notified body (NB) capacity in the European Union is well known, but a recent survey of NBs suggests that more than 17,000 certificates for medical devices and active implanted devices issued under the legacy regulation are set to expire by the end of 2024. More troubling might be the fact that the number of standing applications dwarfs the number of completed applications by a ratio of more than four to one, a gap that continues to grow as calendar year 2022 unwinds. Read More
After getting its 510(k) application rejected by the U.S. FDA for its AI-enabled Salix coronary anatomy software (SCA), Australian medical technology company, Artrya Ltd. scored regulatory approvals in the UK and in the EU. Read More
The first home pregnancy test to analyze saliva rather than urine is due to be on the shelves in Europe at the start of 2023, following CE approval of Salistick, developed by saliva diagnostic specialist Salignostics Ltd. Read More
Subtle Medical Inc. closed a series B financing to develop its artificial intelligence (AI) imaging enhancement solutions. Eastern Bell Venture Capital Management Co. Ltd. and Primavera Venture Partners lead this round of financing. Read More
Stimulating the brain via implanted electrodes is used to treat both movement disorders such as Parkinson’s disease, and some psychiatric conditions such as obsessive compulsive disorder. But researchers are also working on ways to make such implanted electrodes listen instead of talk – and translate neuronal signals for people that have lost the ability speak, or the ability to move. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Calyx, Concertai, Endonovo Therapeutics, Globus Medical, Imaging Biometrics, Neosoma, NTT Research, Perimed, Revealdx, Sirona Medical, Valvention. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Livanova. Read More
