Amalgam’s Scalable Digital Platform Powers the Mobile App for Biolinq Shine™, an FDA De Novo–Cleared, Needle-Free Glucose Sensor

WILMINGTON, Del.: #clinical--Amalgam Rx, Inc., a leading provider of AI-powered software for regulated medical devices, announced its collaboration with Biolinq Incorporated in developing the digital backbone for Biolinq Shine™, the first fully autonomous, needle-free glucose sensor recently granted De Novo Classification by the U.S. Food and Drug Administration (FDA).

Biolinq Shine marks a major step forward in establishing a new category in continuous glucose monitoring, and Amalgam’s scalable software platform played a key role in enabling rapid software development to support Biolinq’s regulatory timelines. The same architecture that powers Biolinq Shine’s secure, real-time data capture and mobile app feedback will support Biolinq’s broader multi-analyte ambitions, including expansion into additional biomarkers beyond glucose.

“As our software platform partner, Amalgam’s speed of execution contributed to a successful regulatory submission for Biolinq Shine. Their extensible architecture aligns with our roadmap to expand the biowearables market and to support growth in new healthcare verticals over time,” said Rich Yang, Chief Executive Officer of Biolinq. “We’re incredibly grateful for Amalgam’s shared mission and talented team.”

“This milestone exemplifies what’s possible when biosensing innovation meets intelligent software,” said Amalgam president, Chris Bergstrom. “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.”

The Amalgam platform is designed specifically for regulated healthcare applications, providing:

• Modularity and scalability across use cases, diseases, and geographies
• Secure, compliant data architecture that meets MDR and FDA standards
• Integration readiness for connected devices and other third-party sources
• Audit-ready oversight with end-to-end traceability and monitoring

This collaboration demonstrates how strategic partnerships between hardware innovators and software specialists can bring safer, smarter, and more accessible connected health solutions to market.

“We’re proud to support Biolinq’s vision of improving metabolic health for millions of people,” added Ryan Sysko, CEO of Amalgam. “Together, we’re setting the standard for digital-enabled biosensors that are both clinically meaningful and commercially scalable.”

About Amalgam Rx

Amalgam Rx empowers patients and providers to make the best decisions possible-within clinical workflows and in everyday life. With a modular SaMD platform, EHR solutions, and Medical-Grade AI, Amalgam partners with global life sciences companies, health plans, and providers to reimagine care delivery. Today, Amalgam’s AI-powered solutions support nearly 10 million patients across four continents and have enabled more than 70 million clinical decisions. Learn more at www.amalgamrx.com.

About Biolinq Incorporated


Biolinq Incorporated is a healthcare technology company pioneering precision multi-analyte wearable sensors to improve metabolic health. The company’s biosensor platform is designed to inform and inspire with unparalleled simplicity to support healthier living. With microsensors that reside just below the skin's surface, Biolinq is redefining the future of continuous biosensing. The company is headquartered in San Diego, CA. For more information, please visit www.biolinq.com.

Fonte: Business Wire