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
QpiAI Open-Sources Its Quantum SDK to Accelerate Global Quantum Software Development8.7.2026 06:30:00 CEST | Press release
QpiAI, a globally leading full-stack quantum computing company, today released the QpiAI Quantum SDK as open-source software. Available now at https://github.com/qpiai/quantum-sdk, the QpiAI Quantum SDK gives developers, researchers, and startups an accessible, developer-friendly toolkit to build and run quantum algorithms and to connect their quantum development workflows directly to QpiAI's 8-qubit and 25-qubit quantum computers through QpiAI-QCloud (https://qcloud.qpiai.tech/). The release is designed to expand access to quantum software development for developers, researchers, universities, startups, and enterprise innovation teams worldwide. By open-sourcing the SDK, QpiAI is giving the global quantum community a practical foundation for building industry-specific quantum solutions across finance, logistics, materials, chemistry, security, AI, optimization, and advanced scientific computing. The QpiAI Quantum SDK provides a Python-based interface for circuit creation, simulation,
Access Advance Welcomes Wave of New Licensees to the HEVC Advance Patent Pool8.7.2026 02:00:00 CEST | Press release
Access Advance LLC, the leading HEVC patent pool administrator, today announced a significant expansion of the HEVC Advance Patent Pool, with 28 companies executing licenses in the first half of 2026. The new Licensees span consumer electronics, automotive, telecommunications, industrial technology, and professional security, reflecting the breadth of industries in which HEVC has become a foundational video technology. "HEVC remains the cornerstone of modern video delivery, and the demand we are seeing from new Licensees speaks to the long-term commercial relevance of this technology," said Peter Moller, CEO of Access Advance. "HEVC licensing activity has been consistently strong, and we are pleased to welcome a number of important new participants to the program." Notably, nine video surveillance equipment manufacturers have joined the HEVC Advance program as Licensees, ranging from three of the world's largest video surveillance equipment makers to specialized developers of security
Empire State Building Observation Deck Run-Up Returns for 48th Annual Race on Oct. 68.7.2026 00:22:00 CEST | Press release
Presented by NYU Langone Health and Powered by MerrellLottery Open Through July 20 The Empire State Building Observation Deck (ESB), atop the “World’s Most Famous Building,” today announced that general lottery registration is open for this year's Empire State Building Observation Deck Run-Up (ESBRU), which will run through July 20, 2026. The annual race, presented by NYU Langone Health and powered by Merrell, will take place on Oct. 6, 2026, at 8 p.m. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707902561/en/ Empire State Building Observation Deck Run-Up Returns for 48th Annual Race on Oct. 6 This year’s race marks the 48th anniversary of the event, in which 225 runners will race up 1,576 stairs of the iconic New York City landmark to reach the world-famous 86th Floor Observation Deck. “Every year, the Empire State Building Observation Deck Run-Up is a remarkable feat for all who participate as they race up to Tripadvi
Modon's Hudayriyat Golf Estates Sets UAE Record With More Than AED 13 Billion in Sales Within Days of Launch7.7.2026 20:36:00 CEST | Press release
A record-breaking sales value for a residential project in the UAEThe project comprises golf mansions, villas, and townhouses across Hudayriyat Island, Abu Dhabi1,700 residences sold within days after the launch15% non-UAE resident buyers81% new customers to Modon Modon has set a new benchmark for the UAE real estate market with the launch of Hudayriyat Golf Estates on Hudayriyat Island, Abu Dhabi. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707126559/en/ Modon's Hudayriyat Golf Estates sets UAE record with more than AED 13 billion in sales within days of launch (Photo: AETOSWire) Within days of launch, the community achieved record-breaking sales exceeding AED 13 billion, marking the highest publicly recorded sales value for a single residential project launch in the UAE. Comprising an exclusive collection of golf mansions, villas, and townhouses, the development saw 1,700 of its residences sold after few days of laun
Loomis Sayles Growth Equity Strategies Team Celebrates Twenty-Year Milestones7.7.2026 16:36:00 CEST | Press release
Loomis, Sayles & Company, the century-old investment manager with nearly $418 billion in assets under management, proudly celebrates the 20-year anniversaries of the Loomis Sayles Large Cap Growth and the Loomis Sayles All Cap Growth strategies, as well as a differentiated approach to growth equity investing under the leadership of Aziz V. Hamzaogullari, CFA, the founder, chief investment officer and portfolio manager of the Loomis Sayles Growth Equity Strategies (GES) Team. Aziz is also an executive vice president and a member of the firm’s Board of Directors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707992418/en/ Celebrating 20 Years of The Power of Active Management Done Right GES is a cohesive team with 20 years of alpha generation and a long-term, private equity approach to investing. Under Aziz Hamzaogullari’s leadership since 2010, assets under management for GES have grown from $1.9 billion to $98.2 billion
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