Our Product Portfolio
New Horizon Biotech develops diabetes management technologies across three core product lines: HorizonFlow Insulin Pump, HorizonGuard CGM, and Blood Glucose Monitoring System. Each platform is designed to support reliable performance, evolving market needs, and the long-term demands of regulated healthcare environments.
Diabetes Management Technologies
New Horizon Biotech’s product portfolio is built around three Class II diabetes platforms, each representing a distinct combination of product maturity, regulatory pathway, and operational complexity. Together, these platforms reflect NHB’s focus on dependable performance, scalable execution, and long-term support for regulated healthcare markets.
HorizonFlow Insulin Pump HF
Model: HF-210 Series
Device Class: Class II
Market Focus: United States, Europe, Asia-Pacific
Regulatory Pathway: U.S. 510(k) strategy; EU technical documentation pathway; China domestic registration pathway
Documentation Status: Legacy platform with maintained lifecycle and component continuity records
HorizonFlow is New Horizon Biotech’s established insulin pump platform and one of the company’s core diabetes management products. Within the NHB portfolio, it is positioned as a mature electromechanical device with a long operating history and a stable market role. Its significance in the case study comes from the operational challenges common to legacy devices, especially component obsolescence, long-term supply continuity, and the need to maintain documentation discipline while supporting ongoing market demand.
HorizonGuard CGM
320
Model: HG-CGM 320
Device Class: Class II
Market Focus: United States, European Union, Australia
Regulatory Pathway: U.S. Class II submission strategy; EU MDR technical documentation and GSPR mapping pathway
Documentation Status: Active evidence mapping and technical file support in progress
HorizonGuard is NHB’s continuous glucose monitoring platform and a key part of the company’s high-volume diabetes portfolio. In the thesis framework, this product line represents NHB’s forward-facing regulatory and technical capability, particularly in navigating EU MDR transition work and structured evidence mapping. It is the product most closely associated with regulatory throughput improvement, because it was used as the primary test bed for linking design, testing, and safety evidence to EU GSPR requirements.
Blood Glucose Monitoring System 105
Model: BGM-105 Flex
Device Class: Class II
Market Focus: United States, Europe, China
Regulatory Pathway: U.S. Class II submission strategy; EU technical documentation pathway; China domestic registration pathway
Documentation Status: New-product-introduction platform with predicate-fit and launch-readiness documentation under development
NHB’s Blood Glucose Monitoring System expands the company’s diabetes portfolio with a complementary glucose monitoring platform designed for routine use environments. In the case-study setting, this line plays a different role from the other two products: it serves as the “cold start” platform for new product introduction learning. That makes it especially useful for testing early documentation readiness, predicate-fit assessment, and the ability of the operating model to support a newer product configuration without the same depth of legacy records available for mature platforms.
