News Medical

The Role of Process Validation in Ensuring Consistent Drug Quality

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...
Business Wire

Sware Raises $6M to Accelerate Life Sciences Innovation by Automating FDA-Mandated Software Validation

BOSTON--(BUSINESS WIRE)--Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, ...
Nasdaq

Spectral AI Reports Over 511 Days of Expert Engagement in DeepView® System Validation for FDA Submission

Spectral AI, a developer of the AI-driven DeepView® System for predicting burn healing, announced that national burn care leaders contributed over 511 in-person days to train and validate the system ...
GEN

AI Could Revolutionize Biopharma Process Validation

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...
EurekAlert!

Almost half of FDA-approved AI medical devices are not trained on real patient data

Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...