Nordson Corp. said it will buy Atrion Corp. for $460 per share in cash, representing a total equity value of approximately $815 million. The transaction enterprise value reflects a multiple of 20.2 times Atrion's 2023 EBITDA, and the $460 per share price represents a 15% premium to Atrion's 90-day average daily volume-weighted average stock price. Read More
A recent hearing in the U.S. House of Representatives highlighted some of the issues Congress has with the agency’s performance, but there were questions as well about the FDA’s statutory authorities. One of these is the lack of statutory authority to require a recall for prescription drugs as well as the deadline for notifying the agency of device recalls, both of which are areas of legislative interest on the part of Congress. Read More
Oncohost Ltd. provided new details on a novel application for its proteomic pattern analysis technology at Biomed Israel last week. While its initial development focused on using a single blood sample to guide selection of first-line immunotherapy for cancer based on likelihood of response, the Prophet platform now also predicts severe adverse immune-related events, Oncohost CEO Ofer Sharon told BioWorld. Read More
Vyaire Medical Inc., of Mettawa, Ill., reported a class I recall of its Twin Tubes devices, which are used in the collection of air samples during cardiopulmonary exercise testing. The recall was prompted by the risk that the device nozzle will separate during patient use and potentially result in choking, although the FDA said there have been no reports of adverse events in connection with the problem. Read More
Researchers affiliated with the U.K.’s University Hospitals Birmingham NHS Foundation Trust filed for protection of a device for treating simple or complex anal or rectovaginal fistulas which is less invasive and more effective than existing treatments. The device combines a bioresorbable scaffold to heal the fistula and a thin comfortable seton to achieve drainage. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ceretrieve, Inspiremd, Predictive Oncology, Sidekick Health, Sight Sciences. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Hitachi, Hyperfine, Opgen, OCT Clinical, Palleos, Radiosurgery Global, Realheart, Roche, Xlife. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Camdiab, Galvanize Therapeutics, Inspira Technologies, Spineart, Toosonix. Read More
