Safer Technologies Programmedical devices FDA designation for Pear 010 to treat acute and chronic pain.

The Safer Technologies Program (STeP) is a voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics. The goal of STeP is to provide patients and healthcare providers with timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health. STeP participation does not imply product authorization. Pear-010 has not received marketing authorization from FDA and it is not available for sale in the United States.

Pear-010 is a PDT ( prescription digital therapeutic) candidate intended to provide a neurobehavioral intervention (virtual reality delivered pain reduction) to patients 18 and older with acute postoperative and acute postprocedural pain. The product candidate is designed to reduce acute postoperative and postprocedural pain and analgesic (e.g., opioid) use related postoperative urinary retention, postoperative ileus, or postoperative unintended advancing sedation and respiratory depression.