EarlySense Inc. has obtained US Food and Drug Administration (FDA) approval for its bedside system and central display system with that includes oximetry (monitoring of oxygen level in the blood).
The EarlySense system is an automatic, continuous, contact-free, patient monitoring solution that monitors and documents a patient’s vital signs and movement using a sensor that slips under a bed mattress. The system is currently installed at hospitals and rehabilitation centers in the US and Europe, and is commercially available in Canada. The oximetry module is a new feature of the system.
The FDA clearance coincides with the Joint Commission’s recently issued Sentinel Event Alert on the safe use of opioids in hospitals, which recommends implementing better dosing along with oxygenation and ventilation monitoring in post-surgical patients. The alert states that opioid analgesics, a painkiller widely used to treat post-surgical patients, may be associated with adverse effects, the most serious effect being respiratory depression, which can potentially lead to death.
EarlySense CEO Avner Halperin said, “EarlySense is the first in the world to combine contact-free respiratory, cardiac and motion monitoring with oximetry.
EarlySense, founded in 2004, is headquartered in Waltham, Massachusetts and has offices in Ramat Gan. Its investors include Israeli funds Pitango Venture Capital, Challenge Fund - Etgar, and ProSeed Venture Capital Fund (TASE:PRSD), as well as JK&B Docor International Management Ltd., Noaber, Bridge Investment Fund, and private investor Peter Soderberg, the managing partner of Worthy Ventures Resources LLC and former president and CEO of Hill-Rom Holdings Inc. (NYSE: HRC).
Published by Globes [online], Israel business news - www.globes-online.com - on October 18, 2012
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