Precision Medical Ventures Inc.

Precision Medical Ventures Inc. specializes in AI-powered diagnostic tools. Their primary product, the RevealAI-Lung™, is designed to analyze lung imaging data and assist in identifying or characterizing pulmonary conditions. The device leverages artificial intelligence to enhance diagnostic accuracy for clinicians.

Precision Medical Ventures Inc. is headquartered in the United States. While the company’s devices are developed in the US, their portfolio is classified under EU Device Class IIa, meaning they are registered in the EUDAMED database to comply with European Union regulatory requirements. This reflects the company’s focus on global markets where such classification applies.

Devices from Precision Medical Ventures Inc., such as the RevealAI-Lung™, are listed in the EUDAMED database. This registry is mandatory for Class IIa devices in the European Union to ensure transparency, traceability, and compliance with EU Medical Device Regulations (MDR). Listing in EUDAMED demonstrates adherence to EU standards for device classification and market surveillance.

The RevealAI-Lung™ and other devices from Precision Medical Ventures Inc. fall under EU Device Class IIa. This classification is determined based on factors like the device’s intended purpose, risk level, and potential impact on patient safety. Class IIa devices require conformity assessment procedures, including clinical evaluations and risk management, to ensure they meet EU safety and performance standards.