Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Boston Scientific, Brainomix, Contura, Cynosure, Dassault Systèmes, Electrocore, Imaginesoftware, Know Labs, Konica Minolta, Life Spine, Lucid, Medtronic, Nanovis, Pavmed, Perimeter Medical Imaging, Spark Biomedical.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcuro, C2N Diagnostics, Etiometry.
Reflecting a positive reception in the market, Kestra Medical Technologies Ltd. increased the target haul for its planned IPO from $100 million to between $140 million and $160 million in an S-1 amendment filed Feb. 26. The company will offer 10 million shares at $14 to $16 per share, with the final price to be set the week of Mar. 3, just ahead of the offering date.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
Scientists at the University of Aberdeen developed a new scanner that distinguishes breast tumor material from healthy tissue more accurately than current magnetic resonance imaging (MRI) methods.
The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs.
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