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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas Pharma, Cognita Labs, Medical Microinstruments, Neuroem.
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.
The past two device user fee schedules have essentially doubled the volumes collected in the prior fee agreements, a pace that some in industry have described as unsustainable. That issue was front and center again in the first public meeting for the next user fee agreement, with FDA commissioner Stephen Hahn saying the agency’s device center needs more money, and industry representatives arguing that the bulk of the device center’s funding must be obtained through congressional appropriations, not from industry-funded user fees.
RSS
