COVID-19
Roche, Abbott, Hologic, Cepheid, Others Gain 510(k) Clearances in February
The US Food and Drug Administration last month granted clearances for a preeclampsia risk test, respiratory disease tests, and a digital pathology system, among others.
Visby Medical Gains FDA 510(k) Clearance, CLIA Waiver for POC Respiratory Panel
The Visby Medical Respiratory Health Test is a disposable handheld RT-PCR-based assay for the detection and differentiation of SARS-CoV-2 and flu A/B.
The pharmaceutical firm said the decision was related to the cost associated with the molecular tests.
Co-Diagnostics Withdraws FDA COVID Test Submission, Plans New Version of Test
The company now intends to submit an enhanced version of its COVID-19 test for 510(k) clearance.
CMS Potentially Overpaid for OTC COVID-19 Tests by up to $453.8M, HHS OIG Report Finds
CMS officials said they have implemented national controls and sought repayment from dozens of healthcare providers and suppliers.
Oct 29, 2024
FDA Clears Qiagen QiaStat-Dx Respiratory Mini Panel
Sep 26, 2024
Texas Lab Owner Indicted for COVID-19 Fraud Scheme
Aug 26, 2024