Cybeats Technologies Corp. reported a contract renewal for its product, SBOM Studio, with a Top 10 global Medical Device Manufacturer that has a $70 billion market cap. The FDA, which oversees medical device security, released new guidelines that stress the importance of SBOM ("Software Bills of Materials"), for ensuring medical devices remain safe and effective against cyber threats.

The guidelines emphasize traceability and leveraging SBOMs to provide a deep understanding of software components, which helps MDM spot risks and weaknesses, leading to more precise and effective cybersecurity practices. SBOM Studio. allows MDM to understand their software more effectively, including in the third-party and open-source components they deploy, and comply with the FDA's new cybersecurity regulations.

This contract follows several other engagements from the Global Top 10 MDM, including from late 2023 and February 2024, all of which help sustain Cybeats' 100% client retention rate, and demonstrate significant product uptake and clear value proposition to the healthcare industry. With regulations and industry pressures looming, the reason companies keep choosing SBOM Studio is becoming more clear and understandable. The U.S. Food and Drug Administration's ("FDA") solidified its role in regulating medical device cybersecurity with its authority to approve or reject premarket submissions based on compliance with section 524B of the Federal Food, Drug, and Cosmetic Act ("FD&C Act").

This section mandates that Medical Device Manufacturers ("MDM") provide a SBOM for their devices' commercial, open-source, and off-the-shelf software components. To proactively manage cybersecurity risks, MDMs must maintain an accurate inventory of device components, develop vulnerability management and risk assessment processes, provide device patches, and maintain device change records. The FDA's Refuse-to-Accept ("RTA") authority emphasizes the significance of SBOM management solutions like SBOM Studio.