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Six EU countries have turned up the heat on medical product sponsors who haven’t shared the findings of their clinical trials, with significant success, a new analysis finds. Read More
Pulnovo Medical reported positive results for its radiofrequency device for pulmonary arterial hypertension (PAH) in a presentation at the Transcatheter Cardiovascular Therapeutics annual scientific symposium in Boston, Mass. Read More
The Regeneten Biodinductive Implant from Britain’s Smith+Nephew delivered an 86 percent reduction in rotator cuff re-tear rates at 12 months, according to interim study results presented at a conference last week in Dublin. Read More
New research published in the NEJM Evidence shows potential for Nordic Bioscience’s PRO-C6 assay becoming a next-generation biomarker in trials studying patients with heart failure with preserved ejection fraction (HFpEF). Read More
All people are not the same. While glaringly obvious, that truth is often ignored in clinical trials. And fixing that problem requires companies to understand and overcome a myriad of barriers, according to a panel discussion held at the annual meeting of the Regulatory Affairs Professionals Society (RAPS) in Phoenix this week. Read More
South Korea’s Lunit INSIGHT CXR artificial intelligence (AI) system improved radiologists’ findings in chest X-rays in four abnormalities, according to study findings published in JAMA Network Open on Aug. 31. Read More
Three-year results continue to show that Abbott’s Amplatzer Piccolo Occluder, which was approved by the FDA in 2019, is safe and effective in nonsurgically closing a hole in the heart of premature infants. Read More
AposHealth’s Apos biomechanical knee treatment helped most patients suffering from disabling osteoarthritis (OA) to be able to delay knee replacement surgery for 24 months, according to data from an observational study published in the journal Population Health Management. Read More
A group of researchers representing devicemakers, academic institutions and the FDA has published a list of factors device developers should consider when collecting patient preference information (PPI) to help design trials. Read More