Adherium (Nz), Ltd.

Adherium (NZ), Ltd. specialises in inhaler dose sensors, which are designed to attach to specific metered-dose inhalers (MDIs) and dry-powder inhalers (DPIs). These sensors track inhalation events in real-time, helping patients and healthcare providers monitor adherence and usage patterns for respiratory medications like Advair HFA, Ventolin HFA, and Symbicort MDI. The devices are accessory-based and work alongside branded inhalers to provide data-driven insights for asthma or COPD management.

Adherium (NZ), Ltd. is based in the United States. Its devices are authorised for commercial distribution in regulated markets where Class II inhaler accessories are permitted. The company’s products are not company-wide approved but are individually authorised through processes like the FDA’s 510(k) premarket notification for Class II devices, ensuring compliance with relevant medical device regulations.

Adherium’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which is a centralised system for tracking medical devices authorised in the U.S. Additionally, the company’s products undergo the FDA’s 510(k) premarket notification process, a regulatory pathway for Class II devices. These registries ensure transparency and traceability of the devices in the market.

Adherium’s inhaler dose sensors are classified as Class II medical devices under FDA regulations. This classification applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. The 510(k) process is used to demonstrate that these sensors meet the required regulatory standards before they are authorised for commercial distribution.