State-of-the-Art:Unpacking MDR’s Evolving Requirements
Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge…….
3 Ways Privacy-Enhancing Technology Will Improve Medical Products Innovation
PET unlocks innovation, speed and faster paths to revenue by allowing analysis and use of real patient data……
Single-Use Systems: The Future of Biopharmaceutical Processing
Single-use systems represent the future in biopharmaceutical processing of therapeutic drugs with significant advantages over traditional reusable stainless-steel systems and partly disposable systems……
Smart Necklace Can Track Blood Sugar Through Sweat
A sensor fashioned into jewelry can potentially be used as a non-invasive way to measure glucose and other vital signs……
First IVDR for Class D Medical Device
Roche Diagnostics manufactured the newly certified high-risk diagnostic product……
Scratching the Surface: A Roundtable on Coatings and Treatments
Treating the point of contact between an orthopedic implant and the body is key to improving osseointegration and product performance……
Brain-Computer Interface Tech Hits a Huge Milestone
Move over, Elon Musk. Synchron, a rival to Neuralink, has achieved a major milestone for the brain-computer interface (BCI) field with the first-in-human U.S. implant using an endovascular brain-computer interface approach, which does not require invasive open-brain surgery……
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3M to Spin Off Health Care Biz
3M intends to spin off its Health Care business to create two public companies……
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Multi-Layer Extrusion Processes Tackle Tubing Challenges
Minimally invasive procedures are driving innovation…….
J&J Strengthens Its Stronghold in Medtech
Johnson & Johnson’s medtech business saw a competitive growth rate of 6% in the first half of the year……
