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The top clinical areas to receive the breakthrough designation have been cardiovascular, neurology, orthopedic, gastroenterology and urology. Read More
Senior FDA officials at last week’s MedTech Conference in Boston wove the theme of engagement with submitters into a wide array of answers to questions about more rapid development of devices. Read More
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