FDA approves Riverain Medical's Softview Enhanced Chest Imaging technology

Riverain Medical, a leading image enhancement and computer-aided detection company dedicated to providing physicians with tools to assist in image interpretation, announced today that the U.S. Food and Drug Administration (FDA) has cleared the SoftView Enhanced Chest Imaging technology.

SoftView suppresses ribs and clavicles on chest X-rays to produce a soft tissue image that increases clarity and improves the detection of lung nodules. This technology uses existing X-ray equipment to provide a soft tissue image for digital chest X-rays. SoftView delivers no additional radiation dose to the patient and does not require any additional patient procedures or specialized equipment.

SoftView uses image processing and pattern recognition technologies to suppress bone in the chest X-ray. The resulting soft tissue image improves the visibility of tissue within the lung.

Studies from the University of Chicago show that using SoftView significantly improves the visibility of lung nodules and improves the radiologist's accuracy for detecting small (9-30mm) lung cancers on chest X-rays without the need for specialized equipment or increased radiation dose to the patient.

"We found in two studies that SoftView can improve a radiologist's accuracy and sensitivity," explains Dr. Heber MacMahon, radiologist and professor at the University of Chicago. "The technology makes lung nodules more conspicuous, especially when they're hiding behind ribs and clavicles and it achieves this without additional radiation dose to the patient or specialized equipment."

"SoftView is now available in the United States, Europe, Canada and Australia. And has gone through rigorous multi-reader, multi-case studies to validate its effectiveness. We have conducted an impressive amount of analysis to get where we are today with this clearance," explains Diane Hirakawa, CEO and Chairman of Riverain Medical. "We are excited to enter the U.S. market with a unique product that will offer significant clinical value to radiologists and their patients."