National Lab Companies Move Quickly to Market Fujirebio’s Lumipulse for Earlier Alzheimer’s Detection
The new blood-based assay avoids painful lumbar punctures and may quicken Alzheimer’s diagnoses
FDA-dtet
FDA Approves Teal Wand as First At-Home Cervical Cancer Screening
Teal Health, the company manufacturing and distributing the test, says thousands of women are already on a waiting list for the assay
Diagnostics Pipeline: FDA Approves Visby Medical’s Over-The-Counter Women’s Sexual Health Test
It’s the first PCR-based sexually transmitted infection test platform for at-home use
Abbott Ushers Monkeypox Testing into Its New Commercial Phase
Abbott has once more gotten the jump by becoming the first company to get EUA clearance for a commercial monkeypox RT-PCR test kit.
FDA Reopens EUA & Immediate EUA-Less Use Pipelines for Monkeypox Tests
Despite lessons learned from COVID-19 testing, HHS and FDA plan for monkeypox testing remains flawed.
Repeat At-Home COVID-19 Antigen Tests to Avoid False Negatives, FDA Says
The agency is advising people to perform repeat, or serial testing after a negative result, regardless of symptoms.
GAO: FDA Needs Policy to Avoid Repeating EUA COVID-19 Test Mistakes
In a recent report, the GAO says the agency needs a policy when it comes to enforcement discretion regarding tests approved via EUA.
FDA Re-Opens Door to Pre-Submission Requests for Non-COVID-19 IVD Tests
The move comes shortly after the FDA said it was going to decline some pre-submission requests to focus on pandemic-related diagnostics.
Medical Device User Fees Agreement Finally Nearing the Finish Line
Though it took longer than expected, the medtech industry and FDA have finally agreed on medical device user fees for the next five years.
FDA Lays Out New Guidelines for Medical Device Cybersecurity
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
InspectIR Nabs First FDA Approval for a SARS-CoV-2 Breathalyzer
On April 14, the FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
New Deal Reached for MDUFA Medical Device User Fees
The FDA’s Center for Devices and Radiological Health says that the agency and industry have reached agreement on MDUFA V.
One Year Is Not Enough to Harmonize Quality Systems with ISO 13485
...
Already a member? Log in here
