Diagnostics Pipeline: 2024 Trends in FDA Approvals
In vitro diagnostic products approved by the U.S. Food and Drug Administration in 2024 show a continued move toward rapid and point-of-care tests
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Diagnostics Pipeline: Testing for Intestinal Parasites Takes Step Forward
The EasyScreen assay received 510(k) clearance from the Food and Drug Administration earlier this year–but with a catch
Evolving Regulations and Guidelines in Genetic Testing
Understanding the regulatory landscape of genetic and genomic testing, and its impact on clinical practice
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In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.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.
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.
