Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biovica, Outset.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocardia, Boston Scientific, Extremity Medical, Nevro.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akili Interactive, Michelson Diagnostics, Sphingotec, Transit Scientific.
The U.S. FDA posted notice of a class I recall for two hemodialysis catheters made by Covidien Inc., the Palindrome and Mahurkar catheters, due to a catheter hub defect that could lead to mixing of venous and arterial blood. No deaths and only one injury have been reported in connection with the defect, but the recall affects more than 1 million devices that went into distribution starting in June 2017, one of the numerically larger recalls in recent years.
The U.S. FDA has proposed to down-classify optical diagnostic devices and electrical impedance spectrometers from class III to class II, but there was little support for such a change in the first day of a two-day advisory hearing. The panelists saw the risk of a false negative for melanoma as too high to allow such devices to go through the 510(k) program, and thus manufacturers of these devices may continue to be required to file PMAs, replete with costly studies and long timelines to approval.
Dyansys Inc. obtained its second greenlight from the FDA this month for its Primary Relief device to alleviate pain following caesarean-section birth. The company received 510(k) clearance for its First Relief system for painful diabetic neuropathy on July 18. Both systems stimulate nerves on the outer surface of the ear using a percutaneous electrical nerve stimulator (PENS) system.
Limacorporate S.p.A has outlicensed to Orthofix Medical Inc. new medical technology for patients suffering from chronic high dislocation of the hip. The deal, for U.S. market rights, will see the companies combine the limb-lengthening technology of Orthofix’s Fitbone intramedullary nail system with Limacorporate’s 3D-printed pelvic fixation device to form what Emmanuel Bonhomme, CEO of Limacorporate, told BioWorld is “a personalized and unique complex hip replacement solution.”
The U.S. FDA has granted 510(k) clearance to a blood-based biomarker assay for disease monitoring of patients with metastatic breast cancer (MBC). The Divitum Tka assay, developed by Uppsala, Sweden-based Biovica International AB, measures the activity of the enzyme thymidine kinase-1 (TK1) which is highly associated with cell proliferation and a predictive marker of tumor aggressiveness. It is the first liquid cancer cell proliferation biomarker assay to be approved by the FDA for use in monitoring metastatic breast cancer.
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