Medtronic plc and Davita Inc. have agreed to form a new company focused on therapies for renal disease, which will require Medtronic to donate its current kidney care business to the new company. Davita in turn would have to produce $75 million in cash and another $25 million in other assets, but would also have to make as much as $300 million in other payments, depending on the accomplishment of certain milestones. The news comes as Medtronic reports mildly disappointing sales results for the company’s fourth quarter while opening a new front in the two companies’ presence in the renal disease space. Read More
U.K.’s Angle plc has become the first company to receive a U.S. FDA product clearance for harvesting intact cancer cells for analysis. Angle reported it scored FDA clearance for its Parsortix system for the capture and harvest of circulating tumor cells (CTCs) from metastatic breast cancer patient blood. Shares in the AIM-listed company soared by more than 50% following the news. Read More
Healthquest Capital Management Co. LLC closed its oversubscribed fourth fund at its hard cap of $675 million, positioning the equity firm to ramp up its investment at the “convergent points between medical technologies, diagnostics/tools, digital health and innovative services,” the company said. Read More
Australia’s Therapeutic Goods Administration (TGA) has made a range of changes to its medical device regulations in recent years that have largely been driven by the need to keep pace with changing technologies, TGA head John Skerritt said during the Ausmedtech 2022 annual conference in Melbourne, Australia. Read More
Medtech Europe, the European trade association for the medical technology industry covering diagnostics, medical devices and digital health, has just adopted a new code of ethical business practice. Read More
Ignoring congressional sentiment, U.S. Health and Human Services Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health as an independent entity within the NIH. Read More
The U.S. FDA has received a citizen’s petition regarding the use of neuropsychological testing prior to placement of a deep brain stimulation (DBS) device for treatment of Parkinson’s disease. The petitioners, most of whose names were redacted, said that there is no standardized test for this purpose, and thus the patient should have sole discretion of evaluating the meaning of their own tests or the use of these tests should not be seen dispositive of the question of whether to go ahead with placement of a DBS device for Parkinson’s. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akili, Blackrock Neurotech, Co-Diagnostics, Corepath, Genscript. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Lumiradx, Nexus Medical Labs, Rhinostics. Read More
