Aktiia SA’s wrist-worn, continuous blood pressure monitor, which has been in use in the EU since 2021, could soon be coming to the U.S. The Aktiia bracelet uses photoplethysmography, the technology perhaps best known for providing blood oxygenation readings via pulse oximeters, and an algorithm based on thousands of readings to estimate blood pressure as wearers go about their daily activities. Read More
The Biden administration has determined that the public health emergency (PHE) for the COVID-19 pandemic will not be renewed and thus will come to an end in the second week of May. While the end of the PHE will affect some Medicare telehealth provisions that have not been memorialized in legislation, the U.S. FDA’s ability to issue emergency use authorizations (EUAs) will not be immediately affected as that authority was invoked by a separate mechanism. Read More
M.A. Medalliance SA has been awarded a de novo investigational device exemption (IDE) by the U.S. FDA for its sirolimus-eluting balloon. This approval is subject to initiation of a pivotal clinical trial in the U.S. Read More
Regenerative medicine company Relive Biotechnologies Ltd. acquired all operating assets of Germany-listed biotech company Co.don AG to expand its global footprint. Read More
Computational modeling and simulation (CM&S) isn’t the new flavor of the month in the medical device industry, but it hasn’t exactly achieved the status of a buzzword, either. However, the Medical Device Innovation Consortium (MDIC) has published a report which makes clear that these software tools are continuing to open new frontiers in device development, a trend that seems certain to continue to expand in the decades ahead as to-market costs continue to grow. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arima, Atricure, Beckman Coulter, Danaher, Memed, Netsmart Technologies, Protean Biodiagnostics, Shockwave Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics. Read More
