Neuroem Therapeutics Inc. has received breakthrough device designation from the U.S. FDA for Memorem, a bioengineered, wearable head device for the treatment of Alzheimer’s disease. The breakthrough nod, which entitles companies to an expedited regulatory process, follows results from a pilot study showing Memorem can reverse memory loss in patients with the debilitating brain disorder. Read More
Boston Scientific Corp. raked in sales of $2.659 billion during the third quarter, a decline of 1.8% on a reported basis vs. the prior year period. Read More
Developers of tests for the COVID-19 pandemic are deploying an increasingly wider range of test systems for molecular testing, but the FDA’s Toby Lowe said that despite the seeming interchangeability of real-time PCR (rt-PCR) systems, performance of a reference panel for a tweaked test must reflect the use of the rt-PCR system that is listed in the existing emergency use authorization (EUA). Read More
PARIS – At the recent annual HealthTech Innovations Days in Paris, the European investment Fund (EIF) and the world’s largest life sciences consortium, EIT Health Germany, reported the development of a Venture Centre of Excellence (VCoE) in Europe. Read More
HONG KONG – Kangstem Biotech Co. Ltd. has completed research on South Korea’s first artificial liver and is taking the next steps towards the device’s clinical trials. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advisory hearing gives Neovasc Reducer poor marks for efficacy; CMS eyes expanded DME coverage of CGMs; APEC launches Vision 2025 for business ethics; Innovation Alliance voices support for Iancu, PTAB changes. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas Pharma, Cognita Labs, Medical Microinstruments, Neuroem. Read More
Keeping you up to date on recent developments in orthopedics, including: Younger knee replacement patients more likely to require reoperation; New research predicts whether rheumatoid arthritis patients will respond to treatment; Steroid inhalers/pills for asthma linked to heightened risk of brittle bones and fractures. Read More
