In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

AUSTIN, Texas and TOKYO, Nov. 24, 2025 /PRNewswire/ -- According to DataM Intelligence, the U.S. Software as a Medical Device (SaMD) Market Size reached USD 205.12 million in 2024 and is forecast to ...

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 ...

The US Food and Drug Administration (FDA) is moving to relax regulatory requirements for low risk health and wellness ...

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 ...

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. In 2023, the MedTech custom medical software development market will continue growing with ...

The integration of third-party components and software is an increasingly critical area of security risk that needs more attention from medical device manufacturers, says Anura Fernando, global head ...

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...