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eNeura Therapeutics has won FDA approval of its Cerena Transcranial Magnetic Stimulator, the first device approved to relieve pain from migraine headaches. Read More
The FDA’s device center needs to improve consistency in decisionmaking during premarket reviews and ensure all employees are up to speed on its review software systems, Booz Allen Hamilton says in a preliminary set of priority recommendations on the review process. Read More
Oculus Innovative Sciences has received 510(k) clearance for its Microcyn hydrogel for scars resulting from burns, surgery or trauma wounds, with the FDA recognizing the device as substantially equivalent to similar products. Read More
The FDA has granted Japan’s Sumitomo Heavy Industries its first 510(k) clearance for a 23 MeV cyclotron proton beam radiation therapy device that targets cancer cells. Read More