Medtronic plc received U.S. FDA approval to undertake an early feasibility study of its dual-energy Affera cardiac ablation system in sustained ventricular tachycardia. Affera combines both radiofrequency and pulsed field ablation technologies in the Sphere-9 catheter along with high-density mapping. Read More
The med-tech industry has been keen to see government fill in the so-called valley of death for breakthrough medical devices for some years, and 2024 may be the year it is finally done. Scott Whitaker, president and CEO of the Advanced Medical Technology Association said in an Oct. 16 press briefing that a House bill may pass during the upcoming lame duck session, bringing to a close an effort that has been the better part of a decade in the making. Read More
Nyxoah SA recently raised $27 million after selling three million shares in a bid to shore up its capital base as it prepares to commercialize Genio — its obstructive sleep apnea technology — in the U.S. Read More
Sunbird Bio Inc. closed an additional financing round of $14 million Oct. 16, reeling in new funding from Eli Lilly & Co. and the Singapore Economic Development Board’s investment arm, EDBI Pte Ltd. Read More
Clarity Pharmaceuticals Ltd. will begin early next year its pivotal phase III trial for its copper-based radiopharmaceutical, 64Cu-SAR-bisPSMA, for diagnosing prostate cancer in patients with biochemical recurrence following positive U.S. FDA feedback. Read More
In the newest BioWorld Insider podcast, Victoria Lipinska, the America's lead for Quantum Innovation Centers at IBM Quantum, talks about the future of drug development using quantum computing. “The new technology is a completely different branch of computing as opposed to what we know right now, and it's meant to complement what we know, not to really replace it,” she said. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Accuray, Angle, Biostem, Evvy, Femselect, Nexalin. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 10x, Amplitude, Bruker, Celularity, Chemometec, GE Healthcare, InformedDNA, Optimize Health, Paige AI, Ovizio Imaging, Patchrx, Pathpresenter Phenomix Sciences, Sequence Lifescience, Stryker Corp., Tau Systems, Teal Health, Treace Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aspria, Yourgene. Read More
