FDA 510(k) clearance
While most wearable baby monitors are designed with the intention to give parents peace of mind, some experts warn they may do just the opposite.
Neurometrix has received FDA clearance for a new smartphone-controlled version of Quell, its wearable for pain relief, the company announced last week.
GI Logic has received FDA 510(k) clearance for a novel device that noninvasively monitors the digestive system after patients have surgery.
The ACT device paired with a previous phone.
by Bradley Merrill Thompson
Let’s say no one had ever invented the tongue depressor, but this year, in a flash of inspiration, I came up with the idea.
Berkeley, California-based Eko Devices has received FDA 510(k) clearance for its smartphone-enabled stethoscope, called Eko Core as well as the companion smartphone app.
Naperville, Illinois-based PhysIQ has received an FDA 510(k) clearance for its personalized physiology analytics system.
The US Department of Defense may soon start using smartphone-based diagnosis tools to detect traumatic brain injuries in soldiers on the battlefield.
Proteus Digital Health has received an update to its FDA 510(k) clearance for its digital medicine platform, adding a new indication to the clearance.
New York City-based Cohero Health has received FDA 510(k) clearance for its mobile connected spirometer.