Biospectal SA has received a CE MDR class IIa medical device certification for its optical fingertip blood pressure monitoring app, Optibp. The device records fingertip blood flow optically and transforms the information into a pulse wave that it analyzes to estimate blood pressure. Read More
The U.S. FDA’s draft rule for lab-developed tests (LDTs) has proven to be every bit as controversial as expected, although the controversy is only marginally about the workload that would come with rulemaking. Read More
After a nine-month review, the Biden administration is preparing to go where all other U.S. administrations have refused to trod. In releasing a draft framework to help federal agencies decide whether to exercise a federal march-in on patent rights protecting taxpayer-supported drugs and other inventions, including medical devices. Read More
Med-tech financings surpassed $1 billion again in November, with transactions totalling $1.02 billion for the month. Though a decline from the $1.23 billion raised in October, the value is up from September’s $645.75 million. Read More
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Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ametek, Paragon, Arteraai, Microbot Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioporto. Read More
