We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The platform features inhaler sensors designed to automatically capture patient monitoring data, such as “when and how well patients use their medication,” Amiko said. Read More
Both guidances are applicable to all medical devices reviewed either through a 510(k) submission or a PMA application, and new details for combination products are included. Read More
At least three complaint cases evaluated by the FDA lacked the required root cause investigations or rationale for not initiating investigations. Read More
Executives from the participating nine digital health companies shared their stories about when agency staff visited their facilities late last year. Read More
A new briefing from the alliance — formed to safeguard public health interests — comes as the U.K. and the EU negotiate over continuing relations post-Brexit. Read More
Smith & Nephew petitioned the PTO’s Patent Trial and Appeal Board to consider Arthrex’s disclaimer as a request for an adverse judgement in an inter partes review. Read More
The assays are intended to provide improved sensitivity for clinical assessments of patients’ response to tyrosine kinase inhibitor therapies. Read More