PerkinElmer GSP cleared for newborn screening
This article was originally published in The Gray Sheet
Executive SummaryFirm's automated GSP Genetic Screening Processor gains 510(k) clearance, the firm announces Nov. 3. The device, which also earned a CE mark in January, runs many blood samples simultaneously to screen newborn infants for a range of genetic, metabolic or hematological disorders. While the GSP Neonatal TSH thyroid stimulating hormone assay is the first to receive FDA clearance for use on the GSP instrument, several additional newborn screening assays are in development, the firm says
You may also be interested in...
Deal Snapshot: AstraZeneca has sublicensed global rights to its peripheral mu-opioid receptor antagonist to RedHill Biopharma, excluding Europe, Canada and Israel, with RedHill also separately receiving non-dilutive financing from HealthCare Royalty Partners.
The US FDA has overhauled its ‘Purple Book’ to make it a searchable database of biologics information. The agency is also seeking input on next steps.
The International Council for Harmonisation has replaced its 1993 guideline on reproductive toxicity studies with an updated version.