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In the latest update on the FDA’s Breakthrough Devices program, the agency said that 56 medical devices that received breakthrough designations have gone on to gain marketing authorizations as of Sept. 30. Read More
Indianapolis, Ind.-based medical device cybersecurity company TRIMEDX has partnered with Indiana University (IU) Health to create a cybersecurity lab that will test the security of medical devices as part of the development process. Read More
EndoStim has received the FDA’s Breakthrough Device designation for its EndoStim System for treatment of patients with gastroesophageal reflux disease (GERD) who do not respond to drug therapy. Read More
The FDA’s General and Plastic Surgery Devices Panel met on Wednesday and Thursday to consider the agency’s proposed classifications of seven types of devices, voting in all cases to support its recommendations. Read More
Medtronic is spinning off its patient monitoring and respiratory interventions businesses into a new, independent entity that has yet to be named. Read More
In an effort to accelerate drug and diagnostic advances in multiple sclerosis (MS), non-alcoholic fatty liver disease and other conditions, Quest Diagnostics and Decode Health are working on a national platform for gathering and storing trial participant specimens for future RNA analysis. Read More
The FDA aims to help industry prepare responses to deficiency letters by suggesting a standardized format, the agency said in a final guidance released yesterday. Read More