EarlySense wins FDA clearance for patient monitoring system
By Mary Vanac
Ramat Gan, Israel-based medical device company EarlySense Ltd., which recently closed a $13 million fund-raising round, received Food & Drug Administration clearance to sell its EverOn Touch patient monitoring system in the United States.
EverOn is a patient supervision system that goes underneath a hospital bed mattress. The device measures patients' vital signs, such as heart and respiration rates, as well as movements to alert caregivers about their medical condition.
The Touch version of the product includes an online display that alerts medical staff about a patient's motion level and verifies patient turns by nurses, the company said in a press release. Identifying low patient movement and then turning patients methodically can prevent pressure ulcers, one of the most costly patient safety risk in U.S. hospitals.
"Today's FDA clearance news further validates our technology," said Avner Halperin, EarlySense chief executive, in the release. "We have repeatedly heard from our partner hospitals that preventing pressure ulcers is a critical need due to the enormous burden pressure ulcers place on hospital budgets and the huge task of preventing them. The addition of pressure ulcer prevention support capabilities to a system that already delivers vital sign detection and bed exit alerts further enhances the EverOn as a full contact-free patient safety suite for hospitalized patients."
Clinical evaluations performed worldwide showed EverOn has significantly improved clinical and economic outcomes for hospitals using the system, the company said.
"The EverOn Touch system incorporates feedback we have received from our clinical sites requesting a more convenient touch screen interface, as well as more comprehensive patient motion monitoring, especially as it relates to patients at risk of pressure ulcers and falls," said EarlySense vice president of clinical and regulatory affairs Dalia Argaman in the release. "The FDA clearance strengthens our belief that EverOn will make a positive impact on the future of clinical practice and improve patient care both at the hospital and in post acute care settings."
In early June, EarlySense raised $13 million from mostly Israeli investment firms to launch its improved monitoring system in the United States and Europe. Bridge Investment Fund in Cleveland, Ohio, also is an investor and participated in the recent fund-raising round.
The company last year received a grant from the Global Cardiovascular Innovation Center led by the Cleveland Clinic. At that time, EarlySense said it planned to establish a base of operations in the Cleveland area to develop the next version of its patient-monitoring device. "We have not opened an office yet," Halperin said through a spokeswoman early this month. "We are now in the hiring process, and we are looking at several options regarding locations in the USA."
EarlySense has an office in Dedham, Massachusetts.