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Top Medical Device Network News
FDA · United StatesThe U.S. Food and Drug Administration has approved Flow Neuroscience's at-home brain stimulation device to treat depression, offering an alternative to typical antidepressants that can cause side effects with long-term use, the company said on Thursday.See the Story
Flow Neuroscience wins first FDA approval for at-home brain-stimulation depression treatment
44% Center coverage: 25 sources
United States · United StatesHeartBeam Inc. (NASDAQ: BEAT) has received FDA 510(k) clearance for its 12-lead ECG synthesis software for arrhythmia assessment following a successful appeal of a prior not substantially equivalent (NSE) determination. The clearance represents a significant regulatory milestone for the medical technology company, which focuses on transforming cardiac care through personalized insights. The company’s patented cable-free technology captures cardi…See the Story
