Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Equashield, Neurosigma, Procisedx.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Castle Biosciences, Dexcom, DNA Diagnostics Center.
Cordis Corp. covered its bets a bit as it closed the acquisition of M.A. Med Alliance SA (Medalliance) announced almost a year ago. While the total payment for the company could total $1.135 billion, it could take six years for the owners of privately held Medalliance to see most of the funds.
The U.S. FDA has finally let fly with a draft rule for regulation of lab-developed tests (LDTs), an 83-page document that delves into the legal controversies regarding whether the agency has the requisite statutory authority. However, Allyson Mullen, a director in the D.C. office of Hyman, Phelps & McNamara P.C., told BioWorld that the emergence of this draft rule doesn’t mean Congress won’t eventually be dragged back into the LDT fray, particularly if stakeholders litigate to overturn the draft.
After a long and bumpy path to approval, the U.S. FDA has finally given the green light to Cyclopharm Ltd’s Technegas combination product a day after the Sept. 29 PDUFA date.
Following the receipt of a U.K. Conformity Assessed (UKCA) mark for its kidney function diagnostic software, the CKD Screening Prioritizer (CSP), Gendius Ltd. is hoping to soon receive CE mark and then U.S. FDA approval next year. Given that people with type 2 diabetes are at a higher risk of developing chronic kidney disease, Gendius’ pre-screening software will be “transformative” for patients and health care systems, CEO Rory Cameron told BioWorld in an interview.
U.S. researchers reported seeking patent protection for methods to neutralize circulating tumor cells (CTCs) during hemodialysis to prevent cancer metastasis and reduce cancer-related deaths.
New hires and promotions in the med-tech industry, including: Bonalive Biomaterials, Ceribell, Cutera, Shoulder Innovations, Spectral Medical, Tactile Systems.
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