In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

Key market opportunities lie in developing medical software and healthcare apps with a strong focus on safety, quality, and effectiveness. Leveraging AI/ML technologies, understanding clinical ...

For manufacturers of software-containing devices, a clear understanding of all relevant standards is crucial. This article takes a close look at the past, present, and future state of those standards.

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...

The data reveals key market opportunities in enhancing compliance through expertise in PMS, PMCF, and vigilance for digital health technologies. Emphasizing real-world data, risk management, and ...

For SLAS US 2023, we speak to Guy Starbuck, one of the co-founders at AIQ Global, about how we can utilize AI technology to bring new medical devices to market. Please could you introduce yourself and ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Discover how medical 3D printing creates patient-specific devices and custom prosthetics. Read our guide to clinical ...