WILMINGTON, DE — Amalgam Rx, Inc. has announced a collaboration with Biolinq Incorporated to develop the digital infrastructure behind Biolinq Shine™, the first fully autonomous, needle-free glucose sensor recently granted De Novo Classification by the U.S. Food and Drug Administration (FDA).
The partnership represents a major advancement in continuous glucose monitoring (CGM), combining Biolinq’s biosensing technology with Amalgam’s regulated healthcare software platform. Amalgam’s modular architecture enabled Biolinq to accelerate software development to meet FDA submission timelines while ensuring secure, real-time data capture and integration with mobile applications.
Biolinq Shine is designed to provide users with continuous, needle-free glucose readings and personalized feedback, marking a significant shift toward more accessible and comfortable metabolic monitoring. The same digital framework supporting Shine will also serve as the foundation for Biolinq’s planned expansion into additional biomarkers beyond glucose, opening the door to a broader range of wearable diagnostic tools.
“As our software platform partner, Amalgam’s speed of execution contributed to a successful regulatory submission for Biolinq Shine,” said Rich Yang, Chief Executive Officer of Biolinq. “Their extensible architecture aligns with our roadmap to expand the biowearables market and support growth in new healthcare verticals over time.”
Amalgam President Chris Bergstrom said the collaboration underscores how technology integration is reshaping personalized medicine. “This milestone exemplifies what’s possible when biosensing innovation meets intelligent software,” Bergstrom said. “Together, we’re redefining how people can understand and act on their health—establishing a blueprint for how software and sensors can evolve together to enable personalized care at scale.”
Amalgam’s software is purpose-built for regulated healthcare applications, offering scalable deployment across therapeutic areas, secure compliance with MDR and FDA standards, and interoperability with connected devices and third-party systems.
Amalgam CEO Ryan Sysko added that the collaboration highlights a growing shift toward intelligent, data-driven healthcare solutions. “We’re proud to support Biolinq’s vision of improving metabolic health for millions of people,” Sysko said. “Together, we’re setting the standard for digital-enabled biosensors that are both clinically meaningful and commercially scalable.”
The partnership positions Amalgam and Biolinq at the forefront of a new wave of digital health innovation—one focused on merging device intelligence with real-world data to make personalized care more precise, efficient, and widely accessible.
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