FDA Radiology AI Devices

The ShortCut device by Pi-Cardia Ltd. is a single-use catheter designed to safely split bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures in patients at risk of coronary obstruction. This catheter-based tool is inserted via the femoral artery and positions its distal cutting element on valve leaflets to perform precise cuts, helping improve blood flow and reduce complications during transcatheter valve replacement procedures. It has been demonstrated in clinical studies to be effective and safe, providing a new treatment option for high-risk patients undergoing valve-in-valve procedures.

Oxehealth Vital Signs is a software device that analyzes video images captured by standard cameras to noninvasively measure a patient's pulse rate and estimated breathing rate. It uses proprietary algorithms to monitor skin pixel intensity changes and chest wall movements, allowing healthcare staff to perform vital sign spot checks without disturbing the patient. This is especially useful in hospital or secured environments where minimizing patient contact is advantageous.