PHC’s in vitro diagnostics division has received European Union Medical Devices Regulation (EU-MDR) certification for APP-1000, a motorized drug injection device.
The class IIa portable medical device, is intended for delivering anti-inflammatory medications called tumour-necrosis factor (TNF) inhibitors.
It has been designed for providing precise, simple, and monitored drug injections at home for conditions that include rheumatoid arthritis.
Manufactured at PHC IVD’s Wakimachi plant in Japan, the drug injection device allows patients to self-inject TNF inhibitors automatically without measurement or preparation.
It comprises an LCD screen with illustrated guidance which makes it easier for patients to use.
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The company stated that users can transfer the dosing history which is stored in the device memory to a smartphone through Bluetooth.
This allows patients and doctors to check the dosing record at any time remotely.
Additionally, patients will have the option to choose from three injection speeds depending on their need.
PHC IVD director and PHC Corporation board member Hiroyuki Tokunaga said: “We strive to provide best-in-class healthcare solutions that meet the needs of healthcare professionals and improve patients’ quality of life, by integrating precision manufacturing with digital technology.
“This EU-MDR certification will enable APP-1000 to be available to more patients and is an important milestone in our work to improve healthcare in the field of digital injectors.”
The receipt of EU-MDR certification allows the company to distribute the new motorized drug injection device in approximately 20 countries including Switzerland, South America and EU countries after June this year.
The EU-MDR regulation replaces the Medical Devices Directive and the Active Implantable Medical Devices Directive.