FDA approves Visensia Alert for market

CARMEL, Ind.

The Food and Drug Administration has given 510(k) clearance to OBS Medical to market its Visensia Alert product in the United States, OBS announced Wednesday.

Visensia, trademarked as VitalAlert, fuses up to five vital signs into a numerical index, including heart rate, respiration rate, body temperature, oxygen saturation and blood pressure. The index indicates a patient’s wellness and can enable significant improvement in clinical outcomes and help optimize a hospital’s resource utilization, the company said.

“Clinical workflow today’s hospital is stricken by high rates of monitor false alarms, compromising patient safety and increasing operational costs,” OBS president and chief executive officer Frank Cheng said. “As confirmed by recently published data from a large-scale, award-winning clinical study, Visensia VitalAlert can enable a high-precision alerting process resulting in reliable identification of patient crisis.”