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A successful paradigm shift focusing on software is heavily dependent on collaborative interactions, said Bakul Patel, CDRH’s associate director for digital health. 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
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 Brexit Health Alliance called for post-Brexit cooperation between the European Union and the United Kingdom on medical device regulations to avoid disruption of international supply chains. Read More
A jury in a Northern California District Court awarded biotechnology company Illumina $26.7 million in a patent suit against Ariosa Diagnostics, finding that Ariosa used patented prenatal testing technology without authorization. Read More
The FDA will be looking for new authority to regulate diagnostics, Commissioner Scott Gottlieb said in a session on precision medicines at the World Economic Forum in Davos, Switzerland. Read More