EarlySense has announced it has received FDA Clearance for its bedside system and central display system with oximetry integration, according to a news release (pdf).
The patient monitoring system combines contact-free respiratory analysis with oximetry, according to the company.
"EarlySense is the first in the world to combine contact-free respiratory, cardiac and motion monitoring with oximetry," said Avner Halperin, CEO of EarlySense, in the release. "This means, that for the first time ever, hospitals have the ability to monitor the oxygen saturation of a patient in addition to automatically, continuously and in a contact-free manner, monitor that same patient’s vital signs and movement. The oximetry component, meant for post-surgical patients who require a higher level of supervision, seamlessly integrates into the existing EarlySense system, including the central display station. The combination of deliverables provides clinicians with a flexible tool to facilitate individualized care plans for optimal clinical outcomes on the medical surgical floors."
The new oximetry feature of the EarlySense system will be introduced at Medica 2012 in Germany in November and officially launched into the market in 2013.
EarlySense is headquartered in Waltham, Mass.
Related Articles on FDA Clearances:
Kelyniam Receives FDA Clearance for Craniofacial Implants
Focus Diagnostics and 3M Receive FDA Clearance for Flu A/B and RSV Direct Test
Alma Lasers Receives FDA Clearance for Skin Resurfacing Module