Philips gets FDA nod for noninvasive liver assessment

FDA
Philips claims its product offers a larger field of view than rivals

Philips has received FDA 510(k) clearance for its noninvasive test of liver tissue stiffness. The FDA nod (PDF) positions Philips to pitch its ultrasound ElastQ Imaging offering as an alternative to biopsies for physicians assessing damage from liver diseases including hepatitis C and NASH.

ElastQ uses shear wave elastography to simultaneously image and assess the stiffness of the liver. The approach works by creating and measuring shear waves in soft tissue. Variations in the speed of the wave correspond to the stiffness of the tissue. Liver stiffness is a surrogate marker of liver conditions such as fibrosis and cirrhosis. And, as such, knowing the stiffness of liver tissue can give physicians insights into the stage of a patient’s disease and the damage done to date.

The same idea underpins offerings including FibroScan, an early entrant to the noninvasive liver testing space. Philips is touting the large field of view, color-coded quantitative assessments and real-time feedback in its attempt to carve out a sizable piece of the market. Even if it only captures a small slice of the sector, the rise of liver diseases such as NASH means the opportunity could be sizable.

"There is a significant population at risk for liver disease that may not even know it," Richard Barr, M.D., Ph.D., a radiologist at Southwoods Imaging, said in a statement. "As a radiologist, I see every day how important liver assessment is becoming, and I'm hopeful that this solution will help patients get the diagnosis, monitoring and treatment they need."

Philips and its rivals for the noninvasive liver assessment market are being driven by the same forces that have made liver diseases some of the most competitive niches in drug development. Obesity and other lifestyle factors are contributing to an uptick in liver disease, expanding the market for ways to diagnose and treat such conditions.

Historically, liver biopsies were needed to make diagnoses, but in recent years imaging has emerged as a more convenient alternative.