In sharp contrast with the biopharma industry, the med-tech industry has completed mergers and acquisitions worth a record amount in the first quarter of 2022, with the $63.7 billion combined value towering over every full year prior to 2021.
Orthoson Ltd. closed a £8.9 million (US$11.1 million) oversubscribed series A, which will be devoted to completing preparations for its ultrasound/hydrogel combination treatment for repairing degenerated spinal discs to start phase I clinical trials.
The legislation that would reauthorize the U.S. FDA’s user fee programs is now in the works in the House of Representatives, but the legislation is fairly lean when considering the number of issues facing the agency.
The U.S. FDA’s pre-certification (pre-cert) program for software as a medical device (SaMD) seemed to run out of steam before the COVID-19 pandemic arrived, but the FDA was always presumed to need help from Congress to roll out a permanent version. A session at this year’s MedCon suggests that there is still life left in the pilot version of the SaMD pre-cert program, a critical development given that the legislation for the device user fee program offers the FDA no new statutory authority for a novel software regulatory framework.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Access Vascular, Clarius.
Mirvie Inc. has secured U.S. FDA breakthrough device designation for its pre-eclampsia risk test. The blood test combines machine learning and liquid biopsy technology to provide an RNA profile that predicts pregnancy risks before symptoms occur. It is the first test to be recognized by the FDA for the early identification of pre-eclampsia.
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