Biolinq Shine™
First needle-free wearable glucose sensor with integrated activity and sleep data
Device · EmbeddedCompany source
Company profile
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.
Company description Amalgam Rx official website
Primary marketChronic Disease Management & Digital Therapeutics
Commercial modelCommercial information available on request
Company presenceLinkedIn
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- Alzheimer's disease
- Bone marrow transplant recovery
- Chronic diseases requiring medication adherence
- Myeloproliferative neoplasms (MPNs)
- Type 2 diabetes
Who it serves
- Health plans
- Health systems
- Healthcare providers
- Life sciences companies
- Pharmaceutical companies
Deployment & integration
Cloud Saas · Embedded deployment with recorded integration context.
Recorded integration context: EHR systems (unspecified vendors), Glucose sensors, Wearable devices.
Geographic context
Markets4 continents with regulatory clearance (specific countries not detailed) · Europe · United States
Company sourceOfficial website
Company milestones
Platform expansion
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.
Partnerships
Recorded partners
- Biolinq (Biolinq Shine glucose monitoring system)
- Global life sciences companies (unnamed)
- Health plans
- Otsuka Digital Health (Elevmi for Alzheimer's caregivers)
- Provider organizations
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
Bone Marrow Transplant Recovery Support
Supports BMT patients through 100-day recovery with symptom tracking and education
Software · Cloud SaaSCompany source
Digital Products (DTx & Companion Apps)
Custom digital therapeutics and companion products for life sciences companies
Software · Cloud SaaSCompany source
EHR Solutions
Point-of-care solutions integrated into provider workflows for patient identification and care
Software · EmbeddedCompany source
Elevmi (Alzheimer's Caregiver Support)
AI-powered support for Alzheimer's caregivers with instant answers and self-care tools
Software · Cloud SaaSCompany source
Enterprise Platform
Modular, AI-powered SaMD platform for deploying digital health solutions globally
Platform · Cloud SaaSCompany source
Medical-Grade AI™
Conversational AI built for life sciences with rigorous regulatory compliance and patient engagement
Model · EmbeddedCompany source
MPN Symptom Tracker
Empowers MPN patients to track symptoms, labs, and procedures
Software · Cloud SaaSCompany source
PDURS
Post-authorization safety study and pharmacovigilance solution
Software · Cloud SaaSCompany source
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
A digital therapeutic for management of psychosocial aspects of psoriasis: A pre-post proof of concept study.Skin health and disease · Jun 1, 2022
Clinical validation
Clinical-trial records
A Study to Evaluate the My Hematology Oncology Patient Experience (MyHOPE™) For Multiple Myeloma (MM) Digital Care Network in Patients With MMNCT04730505 · Sponsor · TERMINATED
mHealth Titration and ManagementNCT03908762 · Sponsor · UNKNOWN
A Digital Health Tool for Insulin Titration (DHIT) Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control GroupNCT03138447 · Sponsor · COMPLETED
Regulatory
Regulatory records
No linked records are currently available.
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
~10 million patients supported
Total patient reach across deployed solutions
70+ million clinical decisions evaluated
Clinical decision support interactions processed by platform
Biolinq
Software platform partnership for Biolinq Shine™, a fully autonomous wearable glucose monitor
Successful FDA De Novo grant for first needle-free wearable integrating glucose, activity and sleep data
Otsuka Digital Health
Developed Elevmi, an AI-driven caregiver engagement solution for families navigating Alzheimer's disease
Successfully brought Elevmi to life with AI-driven approach to caregiver engagement
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Updates from Amalgam Rx
Recent articles published on Amalgam Rx's official website.
Amalgam Rx Named to the 2022 CB Insights’ Digital Health 150 List
Read on Amalgam RxAmalgam Rx’s DoseCheck Receives SFDA Clearance in Saudi Arabia
Read on Amalgam RxAmalgam Rx Wins “Overall Large Language Model of the Year”
Read on Amalgam RxAmalgam Rx and Otsuka Precision Health, Inc (OPH) Announce AI Digital Support Solution for Caregivers of Patients with Alzheimer’s Disease
Read on Amalgam Rx07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Chronic Disease Management & Digital Therapeutics
Companies using AI and digital health tools to help patients manage chronic conditions through digital therapeutics, gamified health management, and AI-powered coaching. Covers management of all chronic diseases including diabetes, hypertension, COPD, heart disease, and multi-condition platforms. Includes continuous glucose monitoring (CGM) systems with AI analytics and insulin optimization algorithms.
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Linked research, clinical, and regulatory source pathways.
Expanded product, deployment, integration, and partnership research.
Record-level provenance and review context.