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
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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
The Diagnostics Pipeline: First FDA Approval of CRISPR Therapy Possible This Year
The agency recently announced it will decide in December whether to grant clearance for a CRISPR therapy for treating sickle cell disease.
The Diagnostics Pipeline: FDA Issues Groundbreaking Clearance for an RSV Vaccine
In early May, GSK’s Arexvy became the first RSV vaccine to be cleared by the FDA for use in the US in adults aged 60 and up.
The Diagnostics Pipeline: FDA Unveils Plan to End COVID-19 Test Emergency Use Authorizations
On March 27, the agency released a new guidance document to help test developers make the transition to full approval.
FDA Breaks New Ground in COVID-19 & Concussion Blood Testing Approvals
In the period from Mid-February through mid-March, three different products received first-of-their-kind clearances from the agency.
New Breakthrough Device Designations Fall 37 Percent in 2022
According to the FDA’s recently-released annual report, only 135 devices received the designation last year, versus 213 in 2021.
Roche Scores First European IVDR Approval for Diagnostic Tests
The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
Roche Alzheimer’s Early Detection Tests Get FDA Green Light
In this month’s diagnostics pipeline report, Roche gets clearance for two new Alzheimer’s early detection tests.
December 2022 FDA Watch: COPD, COVID-19, and MDD Tests Gain Clearance
A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.
Want Breakthrough Device Designation? You’ll Need to Consider Health Equity
In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.
November 2022 FDA Watch: Pace of New Approvals Slows
Though there were fewer new approvals last month, the impact of the products that did gain approval more than made up for the drop in volume.
