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Strados Labs Gets CE Mark for Its RESP Smart Sensor Platform for Respiratory Health

December 28, 2021

Philadelphia, Pa.-based Strados Labs has been granted CE mark certification for its RESP Smart Sensor platform for measuring respiratory health.

The noninvasive wireless device, which is designed to identify abnormal breathing patterns, can record lung sounds remotely in a range of healthcare settings, such as hospitals, research facilities and nursing homes, the company said.

The RESP Smart Sensor also received the FDA’s 510(k) clearance and has been designated a Class II device by the agency. Class II devices are those with a moderate-to-high risk that require special controls to ensure patient safety.

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