Orsense, Ltd.

Orsense, Ltd. specializes in clinical spot-check systems that measure multiple physiological parameters at once. Their devices, such as the NBM200 and NBM-200MP, are primarily designed for pulse oximetry and real-time monitoring of vital signs like oxygen saturation and pulse rate in healthcare environments. These systems are intended for quick, targeted assessments rather than continuous monitoring.

Orsense, Ltd. is based in the United States. The company focuses on developing clinical spot-check systems that provide simultaneous measurements of key physiological parameters, such as those used in pulse oximetry. These devices are engineered for use in healthcare settings to support clinical decision-making through rapid, accurate vital sign assessments.

Orsense, Ltd.’s devices are authorised through the FDA’s 510(k) pathway, a premarket notification process for Class II medical devices. Their products are also included in the FDA’s Unique Device Identifier (UDI) database, which serves as a standardized registry for tracking and identifying medical devices in the US market.

Orsense, Ltd.’s devices fall under the US FDA’s Class II classification. This category includes medical devices that pose moderate risk and require special controls to ensure their safety and effectiveness. Class II devices typically undergo a 510(k) premarket submission to demonstrate substantial equivalence to a legally marketed predicate device before being authorised for sale.