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
European Wealth Firms Build Private Markets Capability Faster Than They Communicate It, Peregrine Report Finds20.10.2026 10:15:00 CEST | Press release
Capability outpaces communication: 73% of the 30 firms show visible private markets engagement, yet only 40% have a dedicated landing page explaining it to clients Swiss private banks set the benchmark: 70% maintain dedicated private markets destinations, led by Julius Baer, UBP, Pictet and Lombard Odier Visibility is concentrated: five firms generate half of all wealth management media coverage, and alternatives just 7% Europe's leading wealth managers have built genuine private markets capability but most have yet to explain it to the clients they built it for, according to The Wealth 30, a new report from Peregrine Communications. The study analyses how 30 leading UK and European wealth managers and private banks position private markets. It concludes that communication, not product, is now the biggest barrier to differentiation in the wealth channel. Capability outpaces explanation 73% of the Wealth 30 engage in private markets yet only 40% operate a dedicated landing page explaini
Infobip and Yamaha Power Conversational Customer Engagement in Indonesia’s Automotive Sector20.10.2026 10:00:00 CEST | Press release
Global AI-first cloud communications platform Infobip strengthens its collaboration with Yamaha Indonesia Motor Manufacturing (YIMM) to transform customer engagement through WhatsApp-powered conversational experiences designed to drive stronger personalization and faster customer interactions. As Indonesia’s consumers increasingly adopt digital-first purchasing behaviors, Yamaha Indonesia is evolving how it connects with customers across the buying journey. Today’s motorcycle buyers often research products through Yamaha’s social media, websites, and video reviews on YouTube before visiting dealerships, raising expectations for brands to deliver fast, seamless, and highly personalized communication. For more than two years, Infobip has supported Yamaha Indonesia in building connected customer engagement strategies that integrate WhatsApp across the company’s wider digital ecosystem, including its websites, social media platforms, and customer touchpoints. The collaboration reflects the
BRG Survey Finds 71% of Competition Lawyers Say Global Antitrust Policies Grew More Fragmented over Past Year20.10.2026 09:00:00 CEST | Press release
BRG's inaugural Global Antitrust & Competition Report surveys 155 senior attorneys across 15 countries, mapping a new era of enforcement shaped by expanding priorities and mounting political stakes. Global antitrust enforcement is pulling apart along national lines, with 71% of senior competition attorneys reporting that policy became more fragmented across jurisdictions over the past 12 months, according to BRG’s inaugural Global Antitrust & Competition Report. Nearly four in five (78%) also cite cross-border antitrust requirements as a significant or recurring challenge. The report draws on a survey of 155 senior antitrust and competition attorneys across the U.S., Europe and Asia-Pacific (APAC) and in-depth interviews with 18 leading lawyers. It also finds that about 60% of respondents expect antitrust enforcement to expand in scope and intensity over the next 12 months. “Domestic politics and geopolitical considerations increasingly influence the application of competition law acro
Finsei Selects Thredd to Power New Debit Offering20.10.2026 09:00:00 CEST | Press release
Partnership brings scalable payment processing, digital wallet capabilities and advanced fraud controls to integrated business finance platform Thredd, the AI-first issuer processing platform, today announced a new partnership with Finsei, a London-based payments company, to power the processing infrastructure behind Finsei’s new Mastercard debit offering. The partnership reflects a shared focus on simplifying an increasingly complex payments environment. Businesses operating across markets often rely on multiple providers to manage accounts, payments, foreign exchange, cards and expenses. Finsei is designed to bring those capabilities together, while Thredd provides the underlying payment technology and infrastructure needed to deliver a secure, digital-first debit experience at scale. At launch, physical and virtual cards will be available, followed by both Apple Pay and Google Pay. “Businesses increasingly expect their financial tools to work together rather than operate as a collec
Murata Develops World’s Smallest 008004-inch Size (0.25mm × 0.125mm) NTC Thermistor for Space-Constrained Temperature Sensing20.10.2026 04:00:00 CEST | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) announces the development of the world’s smallest* 008004-inch size (0.25mm × 0.125mm) NTC thermistor, the NCU01 series. Compared with Murata’s previous smallest 01005-inch size (0.4mm × 0.2mm) product, the new series reduces mounting area by approximately 60% while achieving equivalent temperature-sensing performance, with resistance tolerance of ±1% and B-constant tolerance of ±1%. Its ultra-compact size enables temperature sensing to be positioned in increasingly restricted spaces and closer to heat-generating components, supporting more accurate and responsive thermal monitoring in smartphones, wearable devices, and other densely integrated electronic devices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261019189089/en/ [Murata Manufacturing Co., Ltd.] World’s smallest 008004-inch size (0.25mm × 0.125mm) NTC thermistor Murata plans to begin sample shipm
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