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
Philip Morris International’s Moira Gilchrist Positions Human Judgment as a Critical Leadership Advantage Amid Rapid AI Adoption at Wall Street Journal Forum8.5.2026 10:00:00 CEST | Press release
PMI’s Chief Global Communications Officer says companies that safeguard human judgment will gain a competitive edge as AI automates routine knowledge work Philip Morris International’s (PMI) (NYSE:PM) Chief Global Communications Officer, Moira Gilchrist, joined global thought leaders at The Wall Street Journal’s Future of Everything conference in New York to examine why human cognition—judgment, context, creativity, and ethical reasoning—is becoming the most valuable asset in an age of artificial intelligence. “The AI boom is putting a premium on distinctly human capabilities,” said Gilchrist, who took part in the session “Cognition: The New Currency – Why Human Judgment Matters More Than Ever.” Speaking to attendees, she emphasized that, “As knowledge is getting democratized, human judgment, intuition, and creativity become the true differentiators that leaders need to nurture across all levels of their organizations.” Philip Morris International is today a different company, built wi
Fortegra Appoints Iwan Röpcke as Chief Executive Officer, Belgium8.5.2026 09:30:00 CEST | Press release
The Fortegra Group, Inc., a global specialty insurer, today announced the appointment of Iwan Röpcke as Chief Executive Officer, Belgium. Mr. Röpcke brings more than 25 years of insurance industry experience to the role, spanning broking, commercial leadership, and executive management across the Benelux and broader European markets. He joins Fortegra from Lloyd’s Insurance Company S.A., where he served as Country Manager for Belgium and the Netherlands, building out the operation from its early stages and overseeing both business strategy and development. Prior to Lloyd's, Mr. Röpcke held senior leadership positions at Willis Towers Watson (via Gras Savoye), where he served as Head of Sales and Head of the Competence Center. His career also includes roles at Inter Partner Assistance (AXA Assistance) as Commercial Director Benelux, Winterthur Europe Assurances, AIG Europe, Aon Belgium, and Marsh. Mr. Röpcke’s industry expertise spans a range of specialty risk areas, with deep relations
KAYTUS Launches All-QLC Flash Storage at AI EXPO 2026 for 10,000-GPU Clusters8.5.2026 09:02:00 CEST | Press release
KAYTUS’s next-generation all-QLC flash solution delivers fully linear performance scaling for massive GPU clusters, while reducing TCO by 70%, enabling ultra-large-scale computing for the era of agentic AI. At AI EXPO KOREA 2026, KAYTUS officially launched its All-QLC Flash Storage Solution, engineered to deliver high performance, massive scalability, and cost efficiency for 10,000-GPU clusters. The solution addresses data-delivery bottlenecks in ultra-large-scale AI training, helping maximize GPU resource utilization. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508313130/en/ Based on the KR2280 and KR1180 server platforms, the solution is deeply integrated with industry-leading AI-native parallel file systems to eliminate data silos inherent in traditional tiered storage. Purpose-built for read-intensive AI workloads, it overcomes the horizontal scaling limitations of massive clusters. Verified test-data shows that, a
Beneq Appoints Dr. Jason Harrison as Chief Executive Officer8.5.2026 09:00:00 CEST | Press release
Semiconductor industry leader takes the helm to accelerate Beneq’s next phase of growth in atomic layer deposition Beneq Oy, the home of atomic layer deposition (ALD), today announced the appointment of Dr. Jason Harrison as Chief Executive Officer. Dr. Harrison succeeds Dr. Tommi Vainio and will lead Beneq into its next phase of growth across semiconductor, optical, and emerging technology markets. A Strategic Leadership Transition Beneq enters its next phase of growth from a position of strong commercial momentum. Recent milestones include the qualification of the Beneq Transform® cluster tool for volume production of GaN power and RF filter devices; the introduction of Beneq Transmute™ and Beneq Transform® XP, both engineered for high-volume manufacturing (HVM) of specialty semiconductors; growing adoption of the P-Series for coating critical chamber parts in advanced node devices; and selection of the C2R™ for AR waveguide production in next-generation XR optics. Against this backd
World Employment Confederation’s 59th Annual Conference to Address Critical Global Labour Market Concerns8.5.2026 07:12:00 CEST | Press release
Senior leaders from policy, business and international institutions are set to discuss critical labour market concerns at the World Employment Confederation’s Annual Conference, during an era of global transformation and disruption never-before-seen. Taking place on 12-13 May in Toronto and entitled ‘Grow With Talent’, this year’s World Employment Conference – co-organised with ACSESS – arrives at a time of profound economic uncertainty. This gathering of leaders and experts will help define the path forward for the global labour market and set the stage for discussions at the 114th Session of the International Labour Conference (ILC) in June. Bettina Schaller, President of World Employment Confederation (WEC) says: “The question at the heart of this year’s World Employment Conference is: how will we mobilise the world’s talent to drive growth in an era of disruption?At a time of accelerating AI adoption, rapid demographic change and an uncertain global economic outlook, pressure on la
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