Medtronic plc added a second U.S. FDA pulsed field ablation (PFA) device approval to its scorecard with the agency’s greenlight for its Affera mapping and ablation system with the Sphere-9 catheter. Affera brings the first radiofrequency/PFA device to the cardiac ablation market and ups the ante in the PFA competition. Read More
Regenerative medicine company Orthocell Ltd. raised AU$17 million (US$11.28 million) to launch its nerve repair product, Remplir, in the $1.6 billion U.S. market. Read More
The Medical Information Working Group again took up a question regarding U.S. FDA-regulated speech, citing the agency’s new misinformation draft guidance as an example of a piecemeal approach to regulated speech. Read More
Children with autism spectrum disorder (ASD) often must wait years before they get a diagnosis, and that wait time can result in missed opportunities for changing behaviors associated with autism. Read More
Currently, cancer therapy trial-and-error methodology is inefficient and unsustainable. Oncology is the worst therapeutic area for drug trial success; only 3.4% of drugs that enter phase I end up being FDA approved, and 57% fail due to poor drug efficacy in trials. Building tools that may aid in predicting an individual’s response to a specific therapy may help in reducing costs, guesswork, and importantly improve the outcome of patients and accelerate new drug development. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: B. Braun, Epicapture, Integrated Molecular Diagnostics, Jupiter Endovascular, Labgenomics, Levita, Meta, Mölnlycke, Transdiagen, Trinity. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic. Read More
