Early-stage development in technology usually follows a “fail fast” philosophy: build something simple, observe outcomes, 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 ...

The pharmaceutical and medical device industries stand at an inflection point. After decades of reliance on traditional randomized controlled trials (RCTs), computational modeling and simulation (CM&S ...

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 ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

Late last month, India’s drug regulator came out with a draft guidance document to regulate “medical device software” — this move, the medical device industry agrees, could not have come sooner. The ...

Real-time operating systems (RTOSes) allow medical device manufacturers to improve the performance of their medical devices and ensure they meet regulatory requirements. But choosing whether to use an ...

The 2023 State of Cybersecurity for Medical Devices and Healthcare Systems report, a collaboration of the Health Information Sharing and Analysis Center with Securin and Finite State, examined the ...

Artificial intelligence (AI) is no longer the future of healthcare—it’s already here. AI-driven medical devices are diagnosing diseases faster than doctors, guiding surgical procedures with precision ...