FDA expands use for SpectRx' noninvasive Bilichek:
This article was originally published in Clinica
Executive Summary
SpectRx has received US FDA 510(k) marketing clearance to expand the use of its BiliChek noninvasive test for infant jaundice. The BiliChek device, which assesses bilirubin levels in the skin, can now be used to monitor jaundice during and after treatment for the condition, in addition to its use as a point-of-care screening tool. "The additional claims substantially open the available market for the BiliChek," says Mark Samuels, SpectRx' chairman and CEO. The test is sold in the US by Respironics. More than two million babies are affected by infant jaundice every year in the US.
You may also be interested in...
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.
Cidara Offloads Rezzayo, Will Focus On Universal Flu Preventative
Cidara conferred global rights to its novel antifungal to marketing partner, Mundipharma, while reacquiring a flu prophylaxis it licensed to J&J in 2021 and gaining $240m in new funding to back development.