Intelesens, a Northern Ireland-based company, garnered FDA's 510(k) clearance for Zensor, a wearable device that remotely monitors a patient's vital signs both in and out of the hospital.
The device, which is battery operated, clips onto an adhesive patch embedded with electrodes. Zensor can be worn for up to 7 days while it collects data on respiration rates, three-lead ECG, heart rate and movement. The information is then sent to a physician or clinical via wireless connection for review, the company said. The data can also be downloaded directly from the device.
In addition to opening up the U.S. marketplace, the FDA clearance "enables us to target those emerging markets looking to embrace innovative new healthcare technology immediately," Stephen Henderson, a company spokesman, said in a statement.
Previously, Intelesens received approval from the regulatory agency for its Aingeal (2011) and V-Patch (2014) monitors. The Aingeal device is designed for in-hospital use while allowing patients mobility, and the V-Patch is similar to Zensor but uses a cellular connection and is limited in the range of vital signs it tracks.
Earlier this year, Intelesens and Scanadu said they would combine their teams taking part in the Qualcomm Tricorder Xprize. Both companies are finalists in the competition to create a handheld medical scanning device that derives its name from the popular Star Trek television and movie franchise. In the contest, the first place winner stands to get $7 million in financing, second place gets $2 million and third $1 million. The winners are expected to be announced early next year.
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