FDA Watch: AI-Based Sepsis Prediction Test Receives FDA Authorization
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
On March 27, the agency released a new guidance document to help test developers make the transition to full approval.
In the period from Mid-February through mid-March, three different products received first-of-their-kind clearances from the agency.
According to the FDA’s recently-released annual report, only 135 devices received the designation last year, versus 213 in 2021.
The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
In this month’s diagnostics pipeline report, Roche gets clearance for two new Alzheimer’s early detection tests.
A roundup of the significant new diagnostic tests and products that received regulatory approval in the US and around the world.
In draft guidance, the FDA is proposing that medical device makers will need to consider how accessible their products are to underserved populations.
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 has once more gotten the jump by becoming the first company to get EUA clearance for a commercial monkeypox RT-PCR test kit.
Despite lessons learned from COVID-19 testing, HHS and FDA plan for monkeypox testing remains flawed.