A financial freefall left prescription digital therapeutic (PDT) pioneer Pear Therapeutics carved up into four pieces following a bankruptcy judge’s approval of the sale of its assets for a total of $6.05 million. Sleep-focused Nox Health Group took the biggest bite, acquiring the FDA-cleared Somryst PDT for $3.9 million. Other buyers included Harvest Bio LLC, Click Therapeutics Inc. and Welt Corp.
Freenome buys immunodiagnostics company Oncimmune for $16M
Freenome Inc. has acquired U.K.-based immunodiagnostics developer Oncimmune Ltd. for £13 million (US$16 million), in a move that bolsters Freenome’s frontline early cancer detection efforts. While Freenome has been largely focused on getting U.S. FDA’s nod for its colorectal cancer test, Oncimmune already has a CE-IVD marked EarlyCDT Lung blood test, an autoantibody platform and an R&D pipeline of over seven cancer detection signals.
UK government needs to speed up approval of med-tech devices, report
The U.K. government should speed up the approval process for medical devices and strengthen the Medicines and Healthcare products Regulatory Agency as there is an opportunity for the country to provide global leadership in life sciences regulation in medical devices and medicines on the back of Brexit, according to a report. What is more, as the EU grapples with implementing its Medical Device Regulation, the UK can learn from this as it works on implementing its own medical devices regulatory regime.
FDA wraps up morcellation containment bag guidance, but containment use still down
The U.S. FDA has issued a final guidance for non-clinical performance testing for tissue containment bags used during power morcellation procedures, and the FDA had recommended in 2020 containment bags always be during morcellation procedures. Despite the FDA’s advisory, a survey of surgeons published in 2022 suggested that most of these procedures are not done with these containment systems, possibly because the rate of procedure-related complications is considerably higher when containment is used.
US surgeon agrees to pay $43M for unperformed vascular procedures
Most enforcement activities in the U.S. related to physician participation in fraud deals with activities that run to six figures at most, but the U.S. Department of Justice (DOJ) announced recently that it has snared a much bigger fish. The DOJ says that Vasso Godiali of Bay City, Mich., has agreed to pay $43 million in connection with allegations that Godiali billed federal health programs for procedures that were never performed, such as thrombectomies and stent placement in the peripheral arteries in possibly the largest such action involving a physician as the sole suspect.
Holiday notice
BioWorld's offices were closed in observance of Memorial Day in the U.S. No issue was published Monday, May 29.
Also in the news
ABK Biomedical, Blue Earth Diagnostics, Cepheid, Concept Medical, Electrocore, Encare, Establishment Labs, Heartbeam, Inspira, Invitae, Know Labs, Medalliance, Mentice, Nucleai, Olympus, PD Neurotechnology, Pulse Medical, Quantalx, Quibim, Revamp Medical, Samsung, Titan Medical, Zephyrus