Molli Surgical Inc. has won the FDA’s nod for its wire-free localization technology for breast cancer surgery. The company said the Molli system helps radiologists tag cancerous lesions quickly and precisely, facilitating surgical excision and eliminating a source of anxiety associated with breast tumor removal. Read More
Laboratory Corporation of America Holdings (Labcorp) further consolidated its position as a leading provider of rheumatoid arthritis testing with a definitive agreement to acquire the Vectra assay from Myriad Genetics Inc. along with other assets of the Salt Lake City-based company’s autoimmune business unit in a deal valued at $150 million in cash. The transaction is expected to close by the end of the third quarter of 2021. Read More
The history of Medicare coverage of transcatheter aortic valve replacement (TAVR) devices has not lacked for controversy despite the massive positive impact on outcomes. Ashwin Nathan, of Hospital of the University of Pennsylvania, said a new analysis made clear that the expansion of centers qualified to perform TAVR procedures has been nearly all in high population density areas with an existing TAVR program, thus leaving out the still-forgotten rural patient. Read More
In a first for the biotech industry, the European Commission (EC) has imposed a €7.5 million (US$9.05 million) fine on Sigma-Aldrich, under the EU’s 2004 Merger Regulation, for providing incorrect or misleading information during a merger investigation. Read More
HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd. “Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales. Read More
New hires and promotions in the med-tech industry, including: Apollo Endosurgery, Arch Therapeutics, Beyond Air, Bone Health, Deep Genomics, Guardant Health, Heartstitch, Intervenn Biosciences, Nanox, Peak Nanosystems. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Canon Medical Systems USA, Closedloop.ai, Cradle Genomics, Echelon Diagnostics, Ocular Therapeutix, Precipio, Raysearch Laboratories. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic plc., Molli Surgical. Read More
