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Design changes in the new stent include increased catheter flexibility and dual-layer balloon technology, leading to a 16 percent improvement in deliverability, the company said. Read More
The first test available on the new system is a molecular assay that detects the three most prevalent nonviral sexually transmitted infections. Read More
In a congressionally mandated report on diversity in clinical trials, the National Academies of Sciences, Engineering and Medicine (NASEM) recommends the FDA require sponsors to file an in-depth recruitment strategy, either before or with their investigational device exemption (IDE) applications, that details how they intend to make their trial population reflective of the disease or condition’s demographics. Read More
Medtronic released interim results showing that its Evolut transcatheter aortic valve replacement (TAVR) system resulted in a low level of complications and death when implanted using a specific technique. Read More
Abbott reported study findings for its TriClip tricuspid heart valve repair device at the annual European Association of Percutaneous Cardiovascular Interventions (EuroPCR) meeting being held this week in Paris, France. Read More
The breakthrough designation was supported by a clinical trial that found the Wysa product to be more effective than standard orthopedic care and comparable to in-person psychological counseling. Read More
In a recent survey of U.S. clinicians, 95 percent agreed that IV dislodgements pose significant safety risks for patients and hospitals, the company said. Read More
Pharmaceutical manufacturers are playing something of a shell game with inhalers, maintaining their patents and market exclusivity with new products that aren’t really new, according to research reported in the journal Health Affairs. Read More