Tempe, Ariz.-based Gt Medical Technologies Inc. has won the U.S. FDA’s nod for an expanded indication for Gammatile therapy. With this decision, patients with newly diagnosed malignant brain tumors now are eligible to receive the FDA-cleared surgically targeted radiation therapy. Gammatile therapy offers an option vs. waiting several weeks for surgical wound healing before beginning treatment. Previously, the therapy was available for individuals with recurrent brain tumors. Read More
Liquid biopsy startup Elypta AB has raised €6.1 million (US$6.72 million) in a late seed financing led by Industrifonden and Sciety. Norrsken Foundation’s newly launched €100 million “impact-first” fund also contributed to the round. The Stockholm-based company plans to use the money to complete development of laboratory kits and software for measurement and analysis of a panel of metabolites it has identified. Read More
Salt Lake City-based Co-Diagnostics Inc. has finished the principle design work for a polymerase chain reaction (PCR) screening test for the novel coronavirus that has sickened nearly 3,000 with an acute respiratory illness and killed more than 80 people in Wuhan, China. Read More
The patent subject matter eligibility problem has rattled the world of diagnostics for several years, but the U.S. Senate has been silent about legislation in recent months. Patent attorney Michael Borella, of McDonnell Boehnen Hulbert & Berghoff LLP (MBHB), said he does not expect Congress to provide any legislative fix to the problem any time soon. Read More
The final scorecard for med-tech IPOs in 2019 shows that Lake Forest, Calif.-based Inmode Ltd. performed the best since its August debut, while San Diego-based Guardion Health Sciences Inc. lost the most stock value during the year. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Allergan, Anika Therapeutics, Bioivt, Electrocore, Halma, Parcus Medical, Suntech Medical, Ucyte Technologies, Valencell Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cognita Labs, Jubilant Pharma, Imricor Medical Systems, Mauna Kea Technologies Read More
