PHC
The In Vitro Diagnostics Division of PHC Corporation (hereafter, PHC IVD), a provider of medical devices and diagnostics, today announced that it has received European Union Medical Devices Regulation (EU-MDR) certification for a motorized drug injection device that delivers anti-inflammatory medications called tumor-necrosis factor (TNF) inhibitors. The device, called APP-1000*1 , is designed to provide simple, precise, and monitored drug injections in the home setting for conditions including rheumatoid arthritis. The EU-MDR certification clears the way for future distribution of the device in approximately 20 countries including EU countries, Switzerland, and South America.
APP-1000 is a class IIa*2 portable medical device, manufactured at PHC IVD’s Wakimachi plant in Japan. It allows patients to self-inject TNF inhibitors automatically at a touch of a button with no measurement or preparation required. The device comes equipped with an LCD screen with illustrated guidance to make it easier for patients to use. Dosing history stored in the device memory can be transferred via Bluetooth®*3 to a smartphone, allowing patients and doctors to check the dosing record remotely at any time. In addition, patients can choose from three injection speeds depending on their needs.
EU-MDR is a regulation for medical devices applied by the European Commission effective as of May 26, 2021. It replaces the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMD), and establishes rules to improve the safety and quality of medical devices and provide transparency for patients to protect public health and patient safety. TÜV SÜD Product Service GmbH, an independent third-party certification organization (or “Notified Body”) based in Germany, conducted the technical documentation reviews and audits required for APP-1000 to be certified. It is PHC Corporation’s first device to receive the EU-MDR certification.
Hiroyuki Tokunaga, Member of the Board of PHC Corporation and Director of PHC IVD 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.”
This device is currently available in Japan. With the EU-MDR certification, PHC IVD plans to make it available in EU countries, Switzerland, and South America after June 2022.
*1 www.phchd.com/global/ivd/digital-injector
*2 EU-MDR classifies medical devices into four categories, taking into account the intended purpose of the devices and their inherent risks; Class I (lowest-risk), Class IIa, Class IIb, and Class III (highest-risk).
For further information on classification of medical devices: ec.europa.eu/health/system/files/2021-10/mdcg_2021-24_en_0.pdf
*3 The Bluetooth®
word mark and logos are registered trademarks owned by Bluetooth SIG, Inc., and any use of such marks by PHC Corporation is under license. Other trademarks and trade names are those of their respective owners.
About In Vitro Diagnostics (IVD) Division, PHC Corporation
Established in 1969, PHC Corporation is a Japanese subsidiary of PHC Holdings Corporation (TOKYO 6523), a global healthcare company that develops, manufactures, sells and services solutions across diabetes management, healthcare solutions, life sciences and diagnostics. With the mission to contribute to the health of society through healthcare solutions that have a positive impact and improve the lives of people, its IVD Division has worked to improve medical services for patients by contributing to early diagnosis and effective medical care for diseases such as diabetes and asthma through development, manufacturing, and distribution of testing and analyzing devices including blood glucose monitoring systems.
www.phchd.com/global/ivd
View source version on businesswire.com: https://www.businesswire.com/news/home/20220417005004/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
UAE announces Google Gemini Is Now the Most Culturally Accurate AI for Arabs28.11.2025 22:31:00 CET | Press release
The world’s first assessment to assess AI models’ alignment with Emirati identity and values The UAE’s Artificial Intelligence, Digital Economy, and Remote Work Applications Office announced that Google Gemini has ranked first in the “AI in the Ring” Index, the world’s first benchmark designed to evaluate how effectively AI language models reflect Emirati culture, dialects, traditions, and national values through a challenge centered on cultural intelligence within the UAE context. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251128785463/en/ UAE announces Google Gemini Is Now the Most Culturally Accurate AI for Arabs (Photo: AETOSWire) Gemini earned the top ranking following a review of over 400 questions across 7 cultural dimensions and 5,200 generated responses from 11 major language models. A Committee of Emirati experts evaluated the outputs to identify which models demonstrated the strongest cultural understanding. F
GE HealthCare announces CE Mark for the Omni 128cm total body PET/CT system28.11.2025 12:00:00 CET | Press release
FOR USE IN CE-MARK EUROPEAN COUNTRIES ONLY GE HealthCare announces CE Mark for its Omni 128cm total body PET/CT,i a next-generation imaging system designed to advance precision care as well as cancer diagnosis, staging and treatment planning The new system is designed to accommodate head-to-thigh imaging in a single bed to improve workflow and efficiency, and enable a significant reduction in dose/scan time – all important factors, especially for populations like pediatric patients Built for both clinical and research excellence, the system may support the development and evaluation of new clinical pathways, novel PET tracers and emerging theranostic agents GE HealthCare today announced CE Mark for its next-generation Omni 128cm total body positron emission tomography / computed tomography (PET/CT) system,i a major milestone in its mission to advance precision care. Designed to advance cancer diagnosis, staging, therapeutic planning and treatment response monitoring, this innovative sy
King Abdulaziz Foundation Organizes the First Edition of the Forum on the “History of Hajj and the Two Holy Mosques” in Jeddah28.11.2025 10:53:00 CET | Press release
King Abdulaziz Foundation (Darah) held the first edition of the Forum on the “History of Hajj and the Two Holy Mosques”, convened as part of the program of the “Hajj Conference and Exhibition 2025” at the Super Dome Hall in Jeddah, in cooperation with the Ministry of Hajj and Umrah and the Guests of God Service Program, during the period from 9–12 November 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251128600368/en/ King Abdulaziz Foundation Organizes the First Edition of the Forum on the “History of Hajj and the Two Holy Mosques” in Jeddah (Photo: AETOSWire) The forum’s activities were inaugurated following the announcement by His Royal Highness Prince Faisal bin Salman bin Abdulaziz Al Saud, Special Advisor to the Custodian of the Two Holy Mosques and Chairman of the Board of Directors of the King Abdulaziz Foundation, who declared the launch of the forum during the opening ceremony of the “Hajj Conference and Exh
VSO Unveils VCP v1.0, a First-of-Its-Kind Cryptographic Audit Protocol to Restore Trust in AI-Driven Markets28.11.2025 06:30:00 CET | Press release
New open standard replaces opaque server logs with mathematically verifiable evidence, helping market participants meet EU AI Act and MiFID II transparency requirements The VeritasChain Standards Organization (VSO), an independent international standards body, today announced the global release of VeritasChain Protocol (VCP) v1.0, an open cryptographic audit protocol designed to provide mathematically provable transparency for AI‑driven and algorithmic trading systems. VCP replaces mutable server logs with a tamper‑evident chain of cryptographic evidence, enabling regulators, brokers, exchanges and trading firms to move from trust‑based oversight to verification‑based supervision. Why This Matters Now The launch of VCP v1.0 comes at a pivotal moment for global market infrastructure: More than 80 proprietary trading firms collapsed between 2024 and 2025 amid regulatory scrutiny, opaque execution models and frozen payout disputes, leaving a trust gap between traders and platforms. Regula
Andersen Consulting styrker sine kompetencer med BMA27.11.2025 22:48:00 CET | Pressemeddelelse
Andersen Consulting udvider sine kompetencer inden for bæredygtighed og virksomhedsforandring gennem en samarbejdsaftale med BMA, der er et sydafrikansk firma, som arbejder for at styrke konkurrenceevnen i fremstillingsindustrien og fremme inkluderende industriel vækst. BMA, der blev etableret for mere end to årtier siden, arbejder på tværs af produktionsværdikæder – fra producenter til deres kunder – sammen med myndigheder og udviklingsagenturer for at fremme bæredygtig industriel konkurrenceevne. Gennem sine sektorfokuserede industrielle klynger leverer firmaet integrerede tjenester inden for industriel politik og strategisk udvikling, værdikædestrategi, produktionskonkurrenceevne og lean-rådgivning, reduktion af CO2-udledning samt udvikling af små og mellemstore virksomheder og samler interessenter omkring fælles prioriteter og skalerbare, langsigtede løsninger. "Bæredygtig produktion handler om mere end effektivitet. Det drejer sig om at skabe økosystemer, der er regenerative, resi
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom