DyAnsys, a medical device company specializing in the autonomic nervous system, announced this week that it has received FDA approval for a wearable auricular neurostimulation device designed to treat ...

Neuralink, Elon Musk’s frothy brain-computer interface company, poached David McMullen, director of FDA’s office of ...

BlueWind announced today that the FDA granted 510(k) clearance for its enhanced Revi implantable tibial neuromodulation (iTNM ...

Flow Neuroscience has secured FDA approval for its at-home brain stimulation device, the FL-100 wearable device, as a non-invasive treatment for major depressive disorder (MDD).

The agency in July warned WHOOP that its blood-pressure insights feature made the company's wearable product look more like a medical device as it estimated systolic and diastolic values used in ...

Please provide your email address to receive an email when new articles are posted on . The SONU Band was initially approved for adults aged 22 years and older with moderate to severe nasal congestion ...

Boston-based wearable fitness company WHOOP has publicly responded to the FDA's letter from July, stating that its Blood Pressure Insights feature does not need FDA approval as it is a wellness ...

“The FDA process is time-consuming and costly. There’s no reason to do it if your product is not going to cross the line," said Ariel Seeley, a Morgan, Lewis & Bockius partner. The explosion in recent ...

Smartwatches and wearable heart monitors can help detect issues such as irregular heart rhythms. But they also have limits ...