PHC
18.4.2022 07:02:05 CEST | Business Wire | Press release
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
Ant International Research Highlights How Readable AI Memories Can Unlock More Personalised, Privacy-conscious Consumer Experiences2.11.2026 09:52:00 CET | Press release
Human sales and customer representatives have institutional memories to serve clients: their preferences and choices. How can we build a memory mechanism for AI services to create similarly personalised experiences? Ant International’s research on this subject recently received the Senior Area Chair (SAC) Highlight Award from the Best Paper Committee at EMNLP 2026, a leading global AI conference. Why do we need “readable AI memory”? In this paper titled 'Text as a universal interface for transferable personalisation', we look into one fact: until now, AI memory of a user has usually been generated and stored as dense numerical code only the original system can interpret. Two long-standing problems with that: First, today's user profiles are "black boxes" — opaque code locked inside a single app, so activity in one service teaches nothing to another, and every product has to re-learn you from scratch. Second, profiles are welded to the model that created them, so they don't transfer whe
Liberis and Qred Complete Merger Following Regulatory Approval to Create Global SMB Financial Platform2.11.2026 09:00:00 CET | Press release
Key points The merger is complete following regulatory approval. The combined group serves more than 60,000 small businesses across 17 countries, with access to approximately 11.5 million addressable merchants. Emil Sunvisson becomes Group CEO and Rob Fairfield becomes Deputy CEO. Both brands, products, partner integrations and customer relationships continue as they do today. Liberis, a leading global embedded finance platform, and Qred, one of Europe’s foremost digital small business banks, today announced the completion of their merger, first announced in June 2026, following approval from the Swedish Financial Supervisory Authority (SFSA). The merger combines Qred’s regulated banking capability and direct relationships with small businesses with Liberis’s embedded finance technology and distribution through more than 30 partners, including Deliveroo, Vagaro and Nexi. The group serves more than 60,000 small businesses across 17 countries and has access to approximately 11.5 million
Car Connectivity Consortium Expands Focus on Digital Access for Two-Wheelers and Micromobility2.11.2026 09:00:00 CET | Press release
Ahead of EICMA 2026, CCC highlights industry collaboration around secure, interoperable digital access for motorcycles, scooters, and other two-wheeled vehicles The Car Connectivity Consortium® (CCC), the global organization advancing interoperable connectivity between vehicles and devices, today highlighted its expanding work across the two-wheeler and micromobility markets ahead of EICMA 2026 in Milan, Italy. Through its Light Motor & Mobility Task Group (LMTG), CCC is bringing member companies together to address the distinct digital access needs of these markets and identify opportunities to advance standardization and interoperability. Key highlights of CCC's two-wheeler and micromobility work include: Addressing two-wheeler digital access needs: LMTG is examining requirements across motorcycles, scooters, e-bikes and other two- and three-wheeled vehicles. Exploring new applications for digital key technology: Member discussions include vehicle access and starting, access to vehic
OpenGate Capital Completes the Acquisition of Maersk Training, the Global Safety Training and Gas Safety Services Business of Maersk2.11.2026 09:00:00 CET | Press release
OpenGate Capital (“OpenGate”), a global private equity firm, announced today that it has completed the acquisition of Maersk Training and its subsidiary Maersk H2S Safety Services. The company, a provider of global safety training and gas safety services, is being carved out from A.P. Møller - Mærsk A/S (MAERSK A:CPH), a listed integrated logistics company. Terms of the acquisition were not disclosed. Headquartered in Svendborg, Denmark, Maersk Training is a leading global provider of essential safety services and training. Through Maersk H2S Safety Services, the company provides specialized outsourced hydrogen sulphide and Health, Safety and Environment safety services for customers in high-risk operating environments. The H2S Safety Services team provides onsite supervision, monitoring and safety equipment maintenance where the safety of personnel and the protection of assets are critical. Through its training business, the company also delivers safety training, competency developmen
SES to Supply Finnair with Ground-like Connectivity Experience in the Skies2.11.2026 08:00:00 CET | Press release
Multi-orbit inflight connectivity service will deliver faster, more reliable onboard internet experience to 18 Embraer aircraft SES today announced a new agreement with Finnair, Finland's flagship airline, to equip 18 E195-E2s with multi-orbit in-flight connectivity, enabling Finnair’s customers to enjoy fast, reliable internet access throughout their journey. Under the agreement, the Embraer E2 aircraft, which will be line-fitted at Embraer, will be equipped with SES’s electronically steered array antenna (ESA) offering reliable connectivity to the SES multi-orbit network, combining SES’s geostationary (GEO) satellite services with low-earth orbit (LEO) capacity from its partner Eutelsat. The first connected aircraft is expected to enter service in 2027. “Inflight Wi-Fi is a core part of the travel experience,” said Blane Boynton, Senior Vice President Aviation at SES. “SES’s multi-orbit network delivers the reliability, performance and flexibility airlines need today while providing
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