About Amalgam Rx
Amalgam Rx is a digital health technology company that develops AI-powered Software as a Medical Device (SaMD) and digital therapeutic solutions for chronic disease management. The company operates a modular, enterprise-grade platform that enables life sciences companies, health plans, and healthcare providers to build and deploy regulated digital health applications at scale across multiple geographies and therapeutic areas. Amalgam Rx's proprietary Medical-Grade AI™ technology powers conversational interfaces and clinical decision support tools that engage patients, caregivers, and clinicians. The platform supports approximately 10 million patients and has evaluated over 70 million clinical decisions, with regulatory clearances across four continents. The company's solutions span symptom management, medication adherence and titration, patient education, clinical trial recruitment, and care guidelines. Amalgam Rx serves as Manufacturer of Record for SaMD products globally, maintaining FDA 21 CFR Part 820, ISO 27001:2022, ISO 13485, and CE-Mark MDR certifications. Their digital products address conditions including type 2 diabetes, Alzheimer's disease, myeloproliferative neoplasms, and support bone marrow transplant recovery. The company integrates deeply with EHR systems to embed clinical workflows and offers both standalone patient applications and provider-facing point-of-care solutions. Amalgam Rx combines behavioral science, clinical validation through randomized trials and real-world data, and flexible deployment models to deliver measurable outcomes for patients and healthcare organizations.
Clinical Focus
Medical conditions and clinical areas addressed by Amalgam Rx.
Who It Serves
Milestones & Awards
Recent Milestones
FDA De Novo clearance for Biolinq Shine (first fully autonomous wearable integrating glucose, activity, and sleep). Launch of Elevmi for Alzheimer's caregivers with Otsuka Digital Health. Platform scaling to support ~10M patients and 70M+ clinical decisions.
Key Partnerships
Social & Media
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Latest Updates
Amalgam Rx Named to the 2022 CB Insights’ Digital Health 150 List
Amalgam Rx’s DoseCheck Receives SFDA Clearance in Saudi Arabia
Amalgam Rx Wins “Overall Large Language Model of the Year”
Amalgam Rx and Otsuka Precision Health, Inc (OPH) Announce AI Digital Support Solution for Caregivers of Patients with Alzheimer’s Disease
Amalgam Rx Secures $20M Credit Investment from Catalio Capital Management to Accelerate Medical-Grade AI™️ Deployment
Company Details
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