HealthLytix Secures FDA 510(k) Clearance for RSI-MRI+ Imaging Software to Enhance Early Prostate Cancer Detection

On November 27, 2019, VCBeat (WeChat ID: vcbeat) learned that medical technology company HealthLytix announced its breakthrough prostate imaging software, RSI-MRI+, had received U.S. Food and Drug Administration (FDA) 510(k) clearance. Reportedly, HealthLytix will launch RSI-MRI+ at the Radiological Society of North America (RSNA) Annual Meeting, held in Chicago from December 1 to 6.

HealthLytix, founded in 2017 and headquartered in San Diego, California, is dedicated to developing cutting-edge technologies in genetics and medical imaging. Its mission is to revolutionize screening and early detection for cancer and neurodegenerative diseases, thereby improving patients’ quality of life while reducing healthcare costs.

RSI-MRI + leverages a patented advanced diffusion MRI technology, biophysical models, and artificial intelligence to help clinicians improve the early detection and diagnosis of prostate cancer. It is the first FDA-cleared imaging software based on artificial intelligence and innovative tissue microstructure models. In 2019 alone, more than 1.7 million people in the United States were diagnosed with cancer; however, most cancers are detected at late stages.

Early detection and intervention in cancer can improve survival rates for patients. Many cancers, including prostate cancer, are characterized by high cellularity that traps or restricts water movement. The limitation of conventional diffusion MRI is that it does not directly measure restricted water; instead, it relies on a simpler metric known as the apparent diffusion coefficient (ADC).

Although ADC is an important biomarker, it is influenced by various confounding factors that negatively affect the sensitivity and specificity of cancer diagnosis, leading to missed diagnoses or inaccurate results.

Dr. Nathan White, CEO of HealthLytix and co-inventor of RSI, stated: “A key innovation of RSI-MRI+ is its ability to better characterize the complexity of water diffusion within cancerous tissues, thereby enhancing diagnostic performance. For early-stage aggressive cancers, more sophisticated approaches are required to differentiate tumor cells. In the context of cancer, this means isolating restricted diffusion sources from other less relevant sources of water diffusion.”

Peer-reviewed articles from multiple clinical sites indicate that RSI technology offers higher sensitivity and specificity in cancer imaging compared to traditional diffusion MRI. Currently, more than 20 articles on RSI technology have been published, covering various human anatomical regions, including the prostate, brain, and breast. RSI-MRI+ is currently available for prostate examinations. HealthLytix plans to obtain FDA approval in the future to apply RSI technology to additional body regions.

(Compiled by Jiang Ying)