Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

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 ...

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 ...

With more than $10m in cash, and a significantly reduced burn rate, the Company is positioned to fully fund the development of its technology platform. Innolitics specializes in medical device ...

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The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...

Formal methods provide a rigorous mathematical foundation for the specification, development and verification of medical device software. This approach enhances both reliability and safety, which are ...

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 ...

The use of smartphones in healthcare is old news. Despite the decade-old trend, many challenges still exist with utilizing a patient’s smartphone, especially with optimizing both safety and patient ...

On June 7, 2024, the Court of Appeals for the DC Circuit in Medical Imaging & Technology Alliance et al. v. Library of Congress et al., No. 23-5067 (D.C. Cir.), vacated an earlier district court ...