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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
Light Age, a New Jersey-based manufacturer of class II medical lasers, drew an FDA warning letter for 12 different violations flagged during a fall 2017 site inspection. Read More