Heparin analyzer downclassification
This article was originally published in The Gray Sheet
Executive Summary
FDA finalizes reclassification of automated heparin analyzers from Class III to Class II in an Oct. 5 Federal Register notice. The downclassification was based on information contained in a reclassification petition submitted by HemoTech. FDA had proposed the downclassification in September 1992 ("The Gray Sheet" Sept. 21, 1992, p. 23).
You may also be interested in...
Fujifilm Demonstrates Health Specialism With European HealthTech Spinout
From X-ray film in 1936 to the world’s first digital X-ray system in 1983, Fujifilm has a long heritage in medical diagnostics.
Financing Quarterly Statistics, Q1 2024
During Q1, biopharmas brought in an aggregate $30.1bn in financing and device company fundraising totaled $2.8bn; while in vitro diagnostic firms and research tools players raised $724m.
Helping Organizations Deliver On KPIs And Giving Staff A Voice
ImproveWell has won awards for its software technology that allows health care staff at the sharp end of patient care to report on problems as they happen. The outcome is a real-time learning process that contributes to improved operational efficiencies for health systems, says In Vivo Rising Leader Lara Mott.