The FDA has cleared SmartLinx Vitals Plus, a mobile-connected in-hospital patient monitoring system from Qualcomm Life subsidiary Capsule. It received FDA 510(k) clearance for prescription use as a class II medical device. Qualcomm Life completed the acquisition of the French company just last month.
On its website, Capsule describes Vitals Plus as "an innovative patient monitoring system that...
Belfast, Northern Ireland-based Intelesens has received FDA 510(k) clearance for its wearable vital signs monitor, called zensor, designed for monitoring patients outside the hospital.
“This is a significant milestone for Intelesens and zensor," Intelesens Commercial Manager Stephen Henderson said in a statement. "...Not only does FDA clearance give the company access to the world’s biggest...
Photo Credit: Paul Savage Photography
By Padma Nagappan
One of the panels at the recently concluded WLSA Convergence Summit in San Diego focused on how things have changed within the last five years and whether the guidelines the FDA issued last year for devices helps provide clarity in navigating the choppy waters of clearance.
The panel featured two companies that have received 510(k)...
