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FDA Commissioner Robert Califf wants to push the agency toward approving AI assisted medical devices that contain algorithms capable of learning, adapting and changing as they gather and analyze more data — which is not the technology in the AI-assisted devices FDA has approved thus far. Read More
BD has announced a settlement in the class action lawsuit related to its Alaris infusion pumps, agreeing to pay $85 million to resolve all the claims against the company and it officers. Read More
This edition of Quick Notes looks at recent FDA Class I and company recalls involving patient return electrodes, pump-incompatible syringes, unintentional double drug dosing and missing zeroes. Read More
The integration of AI tools like ChatGPT and GitHub Copilot into corporate structures can revolutionize efficiency and productivity, especially in software development and content generation. Read More
Boston Scientific, GSK and Johnson & Johnson have each announced billion dollar acquisitions this week with major deals designed to expand the companies’ portfolios in very specific areas. Read More
Vaporized hydrogen peroxide (VHP) is now an established method of sterilization for medical devices, the FDA said, and can be used in place of ethylene oxide (EtO), which has been under fire for its potential to cause cancer. Read More
How the FDA handles internal scientific disagreements and whether scientists have faced retaliation for expressing differing scientific views is the subject of a letter sent by the House Energy and Commerce Committee to the FDA. Read More