US clearance for Cholestech's ALT (alanine amino transferase) test:
This article was originally published in Clinica
Cholestech has received a 510(k) clearance from the US FDA for its alanine amino transferase (ALT) liver function test. The ALT test will be run on the company's Cholestech LDX system, a telephone-sized device that can perform multiple simultaneous diagnostic tests from a single drop of blood to produce results in less than five minutes. Quantitative ALT measurements are used to help diagnose and treat certain liver disease, such as viral hepatitis and cirrhosis and heart disease, said the Hayward, California-based company.
You may also be interested in...
Device Week, 4 December 2020 – MedWatch Question About Third-Party Servicers Slides Under Industry's Radar
On this week’s podcast: A change made by the US FDA to its MedWatch program that asks adverse event reporters whether a third party serviced a malfunctioning medical device went unnoticed by many in industry for nearly a year. We explain why, and tell how the servicer question will be helpful for manufacturers and the agency.
The series D financing will support the expansion of Everlywell’s consumer lab testing and digital health businesses.
New guidance from the UK regulator covers distribution and deployment of Pfizer/BioNTech's COVID-19 vaccine, which will be complex because of the temperature storage requirements and the large packs in which the vaccine doses will be delivered.