A financial freefall left prescription digital therapeutic pioneer Pear Therapeutics Inc. cut 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. Ltd. The total generated from the assets was woefully short of the company’s $32 million in debt. Read More
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 the 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. Read More
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. Read More
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 used during morcellation procedures. Despite the FDA’s advisory, a survey of surgeons published last year 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. Read More
Most enforcement activities in the U.S. related to physician participation in fraud deal with activities that run to six figures at most, but the U.S. Department of Justice (DOJ) reported recently that it has snared a much bigger fish. Read More
New hires and promotions in the med-tech industry, including: Electrocore, Inspira Technologies, Invitae, Nucleai, Olympus, Quibim, Zephyrus. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Know Labs, Medalliance, PD Neurotechnology, Shape Memory. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABK Biomedical, Blue Earth, Cepheid, Concept Medical, Establishment Labs, Pulse Medical, Quantalx. Read More
