Cybeats license agreement with Starfish Medical

TORONTO — Cybeats Technologies Corp., lands a license agreement for SBOM Studio with StarFish Medical1 (StarFish), a North American-based full-service medical device design company.

“The interest from a prominent medical device company highlights the increasing demand for SBOM management solutions like SBOM Studio, which assists with cybersecurity risk management, and importantly, also helps to comply with newly mandated FDA requirements for SBOMs and ensure a smoother market entry for their products,” said Bob Lyle, CEO, Cybeats.

Cybeats SBOM Studio delivers software supply chain intelligence technology, allowing StarFish to manage Software Bill of Materials (SBOM) and address cyber risks in their medical device projects. The U.S. FDA new Refuse-to-Accept (RTA) authority emphasizes the significance of SBOM management solutions like SBOM Studio. This recent contract with a medical device firm underscores the growing expertise in the healthcare security industry vertical and increasing demand for SBOM solutions within the industry.

The FDA’s role in regulating medical device cybersecurity has significantly increased due to 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.

The ability to institute an RTA decision emphasizes the FDA’s dedication to medical device cybersecurity and the importance of SBOMs for a transparent and accountable software supply chain. Cybeats, already serving one of the largest global MDMs, is in trial evaluations and late-stage contract negotiations with several other leading MDMs worldwide.

The Consolidated Appropriations Act (Omnibus), signed into law in late 2022, amended the FD&C Act’s section 524B, titled ‘Ensuring Cybersecurity of Medical Devices.’ This requires MDMs to disclose a comprehensive list of software components used in their devices, including third-party and open-source elements, and address post market vulnerabilities with patches. 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 urgent need for managing vast amounts of SBOM data has created a large and growing addressable market for solutions like SBOM Studio.
Cybeats Engages Leading Marketing Companies Gold Standard Media and Outside the Box Capital

“We’re thrilled to attract leaders in the marketing world. Our company has grown significantly since our public listing and deserves to be put on the biggest stage possible to tell our story. Both of these companies are leaders in telling unique stories and we’re looking forward to a long-term relationship as we continue to deliver business wins,” said Yoav Raiter, CEO of Cybeats.