New Tech Solution Enables Smartphones to Become Portable Diagnostic Labs
Light AI’s app-based solution achieves gold standard diagnostic-level metrics in pre-FDA validation studies for Strep A, ...
pharmaphorum19d
PEAR raises $50m to develop digital therapeutics business
PEAR Therapeutics has raised $50m in a new financing round to fund development of its prescription digital therapeutics business. Prescription digital therapeutics are clinically-validated, FDA ...
Fierce Pharma10d
India's Aspen Biopharma Labs hit with FDA warning letter citing infrastructure, contamination and records problems
With its active pharmaceutical ingredient (API) facility “in a state of disrepair,” manufacturer Aspen Biopharma Labs’ operations have ground to a halt in the U.S., according to a recent FDA reprim | ...
The Manila Times10d
FDA Recognizes Newly Revised AAMI Sterilization, Ethylene Oxide Guidance
The new entry to FDA's database of Recognized Consensus Standards is AAMI TIR106:2024: Microbiological methods-Understanding ...