Acceleration Therapeutics' AT-101 reclassified by the FDA
This article was originally published in Clinica
Executive Summary
The US FDA has asked Acceleration Therapeutics to reclassify its power exercise device, AT-101, following the discovery that it no longer meets FDA class 1 (exempt) requirements. The company said the matter was of serious concern to its business and is unable to resume selling the product, a full body vibrating mattress, until it receives a 510(k) allowance letter from the FDA.
You may also be interested in...
Probiotics And Cold Remedies Boost Recordati In 2023
Italy's Recordati saw its OTC sales grow by 10% in 2023 driven by the recovery of the cough & cold market and a growing demand for probiotics.
Falling Sales Force New Priorities At Roche
The Swiss major brings a new ruthlessness to the compounds in its pipeline: if they’re not first or best, they’re out.
Human Cell-Secreted Proteins Offer A Wellspring Of Potential Therapeutics
CEO Hanadie Yousef leads Juvena Therapeutics in utilizing an AI-based platform that analyzes cell-secreted proteins to identify potential therapeutics. One of their first near-clinical assets could complement GLP-1s.