PHC Receives EU-MDR Certification for Motorized Drug Injection Device

The in vitro diagnostics division of Tokyo, Japan-based PHC has received certification under the EU’s Medical Devices Regulation (EU-MDR) for a motorized drug injection device that delivers anti-inflammatory medications called tumor-necrosis factor (TNF) inhibitors.

The APP-1000 device features a screen with illustrations to make it easier for patients to use and a choice of three injection speeds. The device allows patients to self-inject TNF inhibitors at a touch of a button, without the need for measurement or preparation.

Dosing history stored in the device’s memory can be transferred via Bluetooth to a smartphone, so patients and doctors can check the dosing record remotely.

The company plans to launch the APP-1000 in EU countries in July.