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
Tanium Reappoints Co-Founder Orion Hindawi as CEO to Drive Next Chapter of Growth20.8.2026 21:10:00 CEST | Press release
Company to focus on deepening its Autonomous IT capabilities, further expanding AI offerings across its portfolio, and strengthening customer and partner engagement Tanium, a leader in Autonomous IT, today announced that Co-Founder and Executive Chairman Orion Hindawi has been appointed Chief Executive Officer, effective immediately. Dan Streetman is stepping down as CEO and as a member of the Board after leading Tanium for the last three years, during which time Tanium scaled its go-to-market operations and secured strong industry analyst recognition for innovation within the Tanium platform. Streetman will continue to advise Tanium as part of the transition and co-founder David Hindawi will return to the role of Chairman of the Board. With this foundation in place, this transition positions Tanium to deepen its Autonomous IT capabilities and further expand AI offerings across its portfolio and strengthen customer and partner engagement. The Hindawis co-founded Tanium in 2007 to build
PCI Energy Solutions to Join Mitsubishi Electric, Reinforcing Long-Term Commitment to Customers, Employees, and the Energy Industry20.8.2026 19:46:00 CEST | Press release
Mitsubishi Electric to retain PCI’s core management team and support continuity of operations, customer service, and product innovation PCI Energy Solutions ("PCI"), a leading U.S.-based provider of enterprise software for energy management and optimization, announced today that it has entered into a definitive agreement to be acquired by Mitsubishi Electric Corporation. The agreement was executed on August 20, 2026 (Japan Standard Time). The Transaction represents a strong endorsement of PCI's business, technology, employees, customer relationships and position in the energy industry. Mitsubishi Electric intends to retain PCI's core management team following completion of the Transaction, enabling PCI to preserve leadership continuity, industry expertise and its customer-focused operating model while benefiting from Mitsubishi Electric's global scale, complementary capabilities and long-term investment capacity. The agreement has been signed, but the Transaction has not yet closed. PC
Perma-Pipe Secures More Than $67 Million in New Orders in the Second Quarter of 202620.8.2026 19:02:00 CEST | Press release
Awards include significant Oil & Gas projects in MENA and Canada, as well as the Company's largest single leak detection project to date and continued growth at its new Ohio facility. Perma-Pipe International Holdings, Inc. (Nasdaq: PPIH), a global leader in engineered piping and corrosion protection solutions, today announced that the Company secured more than $67 million in new orders during the second quarter of fiscal 2026, representing strong demand across its strategically important end-markets and geographies. The orders further strengthen Perma-Pipe's backlog and provide increased visibility into future revenue growth. The Company's backlog remains well diversified across geographies, customers and end-markets. The Company continued to see strong demand across its core Oil & Gas and infrastructure markets, while also securing important new business in emerging applications, including advanced leak detection and monitoring solutions. During the quarter, Perma-Pipe secured sizabl
Impartner Launches the First CPQ Built for Partners20.8.2026 15:00:00 CEST | Press release
New quote management capability brings configure, price, and quote (CPQ) into Impartner’s PRM platform, connecting product configuration, pricing, segmentation, and approvals. Impartner, the leading partner revenue orchestration platform, today announced the launch ofImpartner CPQ, giving partners a direct path to create and advance quotes within the Impartner PRM platform. The new capability enables faster movement from opportunity to submission while giving vendors control over the rules, products, pricing, and approvals that govern each transaction. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260820479441/en/ Give partners a faster path from opportunity to quote with Impartner's CPQ. For many partnership programs, quoting remains a largely manual process. Partners often depend on vendor sales teams to prepare quotes because traditional CPQ systems are designed primarily for direct sellers or require additional licensin
Scientist.com Expands R&D Platform Capabilities with SciSure’s Integrated LabOps Inventory and Compliance Services20.8.2026 14:55:00 CEST | Press release
Strategic integration connects scientific procurement with lab operations, inventory, and EHS compliance Scientist.com, the life sciences industry’s leading AI-enabled R&D orchestration platform and digital marketplace, today announced an expansion of its platform capabilities through an integration with SciSure’s lab management and EHS compliance tools. The partnership gives biopharma organizations a more unified workflow connecting scientific procurement directly with laboratory operations. “By bringing SciSure’s inventory management, safety, and compliance capabilities into the Scientist.com ecosystem, we are closing the gap between sourcing reagents and safely managing them in the laboratory,” said Jon Zibell, VP of Global Alliances at SciSure. “Together, our platforms connect product information, safety checks, and inventory management, giving research, lab operations, and EHS teams greater visibility from purchase request through disposal.” The integration connects procurement, s
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