Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bonesupport, Burning Rock Biotech, Establishment Labs.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endonovo Therapeutics, Foundation Medicine, Infobionic, Medtronic.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allurion, Edwards, Glucotrack, Guerbet, Illumina, Inspiremd, Mindray, T2 Biosystems.
Derek Sham, founder and CEO, of Toronto, Ontario-based Cosm Medical Corp. reported filing for patent protection for devices, systems and methods for vaginal therapeutics. He reported on a range of surgical treatment options for pelvic organ prolapse (POP) and urinary incontinence (UI) as well as non-surgical treatments exist for POP and UI.
No one is looking in the rearview mirror at Medtronic plc as a fresh U.S. FDA approval for the next generation version of its intrathecal drug delivery system allows the company to leave behind a spate of problems associated with its Sychromed II device. The device delivers medication directly to the fluid surrounding the spinal cord via a small catheter positioned to deposit the drug at the site of most severe pain. The targeted delivery improves management of chronic and cancer-related pain as well as management of severe spasticity without use of systemic opioids.
Getinge AB has acquired Healthmark Industries Co. Inc. for $320 million on a cash and debt basis in a bid to bolster its presence in sterile reprocessing in the U.S. The deal was financed using cash on hand and existing credit facilities. Getinge expects to fully integrate Healthmark’s operations by the end of 2024 and is not expected to see any material integration costs in 2023 and 2024.
The European Commission (EC) has ordered Illumina Inc. to sell Grail Inc. after it closed the acquisition without approval from EU regulators. The EC said that if Illumina fails to comply with the order, the company faces fines of up to 5% of its daily aggregate revenue or up to 10% of its annual worldwide revenue.
The FDA town hall on the final day of the 2023 edition of the Med Tech Conference included the usual patter about the achievements at the agency’s Center for Devices and Radiological Health (CDRH), but a few useful nuggets of information nonetheless slipped through in this year’s session. CDRH director Jeff Shuren acknowledged that the agency is steering device advisory committee hearings away from votes on whether to approve a product, an approach he said is under consideration at the agency’s other product centers as well.
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