Regulatory Policy Archives - Page 10 of 12

FDA plans to overhaul 510(k) approval process for medical devices

28 Nov 18

The US Food and Drug Administration (FDA) is planning to overhaul the framework for evaluating the safety and…

22 Oct 18

Ocular Therapeutix has received a warning letter from the US Food and Drug Administration (FDA) related to ReSure…

11 Oct 18

TearLab's Discovery MMP-9 Test has failed to meet criteria for substantial equivalence based upon data and information submitted…

05 Oct 18

MedISAO, a provider of cybersecurity information, education and tools for the medical device industry, has signed a memorandum…

04 Oct 18

The Transparency Committee of the French Haute Autorité de Santé (HAS) has given positive recommendation to Blue Earth…

03 Oct 18

ivWatch has received two patents granted by the European and Japanese Patent Offices expanding their intellectual property (IP)…

07 Sep 18

Intuitive Surgical has submitted a premarket notification to the US Food and Drug Administration (FDA) for its robotic-assisted,…

03 Sep 18

ResMed, a tech-driven medical device firm, has lodged a patent infringement petition against New Zealand-based medical device manufacturer…

30 Jul 18

The US District Court for the District of Delaware has found that Minerva Surgical infringed two Hologic patents…