13 Jan 2014

FDA clears second EarlySense bed sensor for the home

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This month the FDA cleared the second generation of Waltham, Massachusetts-based EarlySense’s passive and contactless bedside monitor, which continuous measures respiration rate, heart rate and motion. Among the changes to the system are more sophisticated management tools to help administrators better measure and track quality goals.

“One of the very strong attributes of our technology and system is that the sensor is placed once under the mattress and that’s it,” EarlySense CEO Avner Halperin told MobiHealthNews in an interview. “There’s no more setup and there’s nothing that the patient has to wear either — they are completely free to move around. Nurses don’t have to waste any of their precious time setting it up or dealing with sensors that fall off. In terms of nuisance alarms, the number of these is order of magnitudes lower — because the patient has nothing to put on, there’s nothing to fall off them. That’s very important these days because physician and nurse time is so valuable — they shouldn’t be using that time to deal with nuisance alarms or setting up sensors.”

Halperin said that currently the product is sold through Welch Allyn to healthcare providers in North America, but this new FDA clearance also clears the device for potential use in the home.

“We started about 10 years ago developing sensing capabilities for the home environment for the patient, and now that we have the hospital environment working so well, we plan to ‘close the loop’ of where we started and bring our solution to the home market,” Halperin said. “We expect to do that in the next two to three years.”

When EarlySense decided to pivot to the hospital market seven years ago, Halperin said it was the right decision because home monitoring was not a mature market yet and its business model was not yet fully apparent. As healthcare providers are now focused on curbing 30 day readmissions and, in some cases, trying to keep patients out of hospitals altogether, Halperin said EarlySense has a growing interest from its hospital customers in migrating their bed sensors to the patient’s home after discharge.

“We are now doing clinical testing of these applications and expect to have something ready to go on that in the next 24 months,” he said.

Halperin also see opportunities for integrating the EarlySense system with other devices and equipment in the patient’s hospital room or room at home, “whether it is the bed itself or the infusion pump, many other devices could get value out of integrating with our device,” he said.