Belong.Life has expanded its digital clinical trial matching program to include patients with multiple sclerosis (MS). The technology uses advanced artificial intelligence (AI) that processes a patient's medical data and determines which trials in its global database are appropriate. The app typically returns results, which are prescreened by a clinical trial coordinator, in less than two days. More than 8,000 cancer patients have used the program so far. Read More
PERTH, Australia – Epi-Minder Pty. Ltd. has completed an oversubscribed series A round of AU$18 million (US$12.89 million) that will see its Minder epilepsy monitoring device enter a pivotal trial to support marketing applications in Europe and the U.S. The smartphone-enabled device promises to improve on wearables and other tools – such as patient diaries – that have proven to be unreliable. Read More
Several senior managers at the Center for Devices and Radiological Health (CDRH) have been pushing the convergence between U.S. FDA and international quality systems standards, often with the claim that the two standards already are nearly completely aligned. However, Jack Garvey, CEO of Compliance Architects LLC, ran through a side-by-side comparison of ISO 13485 and Part 820 and maintained that the two standards are too conceptually and textually different to plausibly assert that they are 95% harmonized. Read More
PARIS – Bonetag SAS, of Perpignan, France, is developing a universal medical device designed to ensure in vivo traceability for orthopedic knee replacements. Read More
Investigators at the University of Heidelberg have identified a previously unknown mechanism for excitotoxicity and used their insight to identify “unconventional neuroprotectant” compounds that could prevent cell death and reduce brain damage in a mouse model of stroke. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIST unveils flow cytometry consortium. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bruin Biometrics, Cytosorbents, Key Surgical, Steris, Wise Therapeutics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, Genmark Diagnostics, Oxford Nanopore. Read More
Keeping you up to date on recent developments in neurology, including: Hydrogel developed to help repair damaged nerves; Evidence of Alzheimer’s, Parkinson’s & MND in brains of young people exposed to dirty air; Study identifies brain cells most affected by epilepsy and new targets for their treatment. Read More
