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.
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Working Group again took up a question regarding U.S. FDA-regulated speech, citing the agency’s new misinformation draft guidance as an example of a piecemeal approach to regulated speech.
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.
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.
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.
Remote monitoring for patients with implanted cardiac electrophysiology devices may finally be coming of age in the U.K. thanks to a review of these systems by the National Institute for Health and Care Excellence.