FDA clears Trinity's AMAX haemostasis analyser:
This article was originally published in Clinica
Executive Summary
Trinity Biotech has received US FDA marketing clearance for its AMAX Destiny haemostasis analyser, an instrument which the company claims allows it to target an additional segment of the $700m haemostasis market. The system offers high-end technology on a small, low cost platform, giving smaller clinical laboratories the ability to process haemostasis tests formerly offered only in large reference laboratories, says the Bray, Ireland-based firm. The product offers the flexibility to perform both optical and mechanical clot, chromogenic and immunoturbidimetric- based assays simultaneously.
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.