8 Recent FDA Medical Device Announcements

Medical devices such as analyzers and assays, must be cleared by the US Food and Drug Administration (FDA) before they can be marketed in the US. The following is a list of some of the key IVD FDA announcements of the year so far.

1. Thermo Fisher Scientific Announces Listing of the Ion PGM Dx System with the U.S. FDA as Class II Medical Device Sept 14
Featured product: Ion PGM™ Dx System

2. Beckman Coulter Receives FDA Clearance on Power Express High-Speed Automated Sample Processing System
Featured product: Power Processor Sample Handling System

3. QIAGEN Receives FDA Approval of PCR Kit to Monitor Cytomegalovirus Viral Load in Organ Transplant Patients
Featured product: Rotor-Gene Q

4. Abbott Announces FDA Clearance for a New Test to Help Physicians Quickly and Accurately Diagnose Diabetes

5. FDA Approval for CliniMACS® CD34 Reagent System for Prevention of Graft-Versus-Host Disease in the Treatment of Acute Myeloid Leukemia

6. HPLC Analyzer Cleared by FDA for Diagnosis of Diabetes
Featured product: G8 HPLC Analyzer

7. FDA-Approval for First-Ever Diagnostic Test Allows Molecular Typing of Red Blood Cells for Blood Transfusions

8. 1st FDA cleared molecular test for Whooping Cough: FDA Clearance for Whooping Cough Molecular Amplification Test: illumigene® Pertussis