PHC
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
Andersen udvider sine kompetencer med tilføjelsen af Scimitar9.1.2026 21:44:00 CET | Pressemeddelelse
Andersen Consulting har indgået en samarbejdsaftale med Scimitar, der er et firma med fokus på at accelerere innovation i biovidenskabsbranchen. Scimitar, der har hovedkvarter i USA, et førende konsulenthus inden for strategieksekvering for biovidenskabsbranchen. Virksomheden er specialiseret i design af driftsmodeller, digital transformation og organisatorisk forandring. Scimitar samarbejder med medicinal- og biotech-virksomheder om at accelerere innovation, styrke den driftsmæssige eksekvering og sikre compliance gennem hele produkters livscyklus. Deres praktiske og samarbejdsorienterede tilgang sikrer løsninger, der ikke blot er formålstjenlige, men også skalerbare. "Virksomheder inden for biovidenskabsbranchen befinder sig i en tid med hurtige videnskabelige fremskridt, stigende regulatorisk kompleksitet og et voksende behov for operationel agilitet, samtidig med at de holdes op mod de højeste standarder for patientsikkerhed og dataintegritet," udtaler Ramy Khalil, CEO i Scimitar.
Biocytogen and Acepodia Expand Collaboration Through Option-based Evaluation Framework for First-in-Class Bispecific and Dual-Payload ADCs (BsAD2C)9.1.2026 13:00:00 CET | Press release
Expanded collaboration builds on Acepodia and Biocytogen’s recent co-development efforts to evaluate selected bispecific antibody and dual-payload ADC programs Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315) and Acepodia (6976:TT), today announced that the companies have entered into an option and license agreement designed to enable the structured evaluation of bispecific antibody-drug conjugate (BsADC) programs to further advance the development of dual-payload bispecific antibody-drug conjugates (BsAD2Cs). The agreement grants Acepodia an option to obtain an exclusive worldwide license from Biocytogen for two BsADC programs. Under the terms of the agreement, Biocytogen is eligible to receive an upfront option fee and, upon Acepodia’s exercise of the option, additional payments including option exercise fees, development, regulatory, and commercial milestone payments, as well as royalties on future product sales. The financial terms of the agreem
Blockstream Capital Partners Announces Strategic Acquisition of Derivatives Trading Team from Numeus Group, Leveraging Strategic Partnership with Komainu9.1.2026 11:08:00 CET | Press release
Blockstream Capital Partners (“BCP”) today announced that it has entered into a strategic agreement to acquire a division within Numeus Group’s digital asset trading and investment business. The transaction includes the absorption of select Bitcoin focused trading strategies with a focus on yield generation as well as a ten person derivatives trading team led by Chief Investment Officer Deepak Gulati, a specialist in volatility and derivatives markets. Deepak Gulati, appointed Co-Chief Investment Officer of Blockstream Capital Management alongside Rodrigo Rodriguez, previously served as Global Head of Proprietary Trading at JPMorgan, before founding Argentiere Capital, a multibillion-dollar volatility-focused hedge fund. With a thesis that derivatives would drive Bitcoin and digital asset market maturity, he co-founded Numeus Group in 2021 to develop institutional-grade trading, risk management and market-structure capabilities. Komainu, an existing BCP strategic investment, has played
Autel Unveils Strategic Shift at CES 2026: Building the AI-Powered Infrastructure of Future Cities9.1.2026 10:44:00 CET | Press release
At the Consumer Electronics Show (CES), Autel Energy is presenting its latest AI-driven smart hardware and software systems for the future of intelligent urban operations. This year’s showcase highlights Autel’s shift from AI concept validation to scenario-based engineering deployment, emphasizing closed-loop execution across real-world infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260101511436/en/ Autel Energy New Product Debut at CES 2026 Focusing on two key domains — Smart Energy and Smart Inspection — the company is unveiling a range of new products. In Smart Energy, Autel is introducing V2G (Vehicle-to-Grid) AC charger for homes and DC charging solution for fleets, strengthening its multi-tier energy touchpoint strategy from households to commercial operations. Live demonstrations at the booth will feature a smart charging robot showcasing automated plug-in capabilities. In Smart Inspection, Autel will
Allianz and Anthropic Forge Global Partnership to Advance Responsible AI in Insurance9.1.2026 10:00:00 CET | Press release
Anthropic’s safety-first AI meets Allianz's dedication to customer centricity, stakeholder trust, and regulatory excellenceThree focus areas of the partnership: workforce empowerment, operations automation through agentic AI, and regulatory compliance Allianz SE and Anthropic today announced a global partnership to accelerate the adoption of responsible Artificial Intelligence (AI) at Allianz. The collaboration centers on three transformative projects within Allianz Group designed to empower Allianz employees and accelerate operations, while setting new benchmarks for accuracy. “With this partnership, Allianz is taking a decisive step to address critical AI challenges in insurance. Anthropic’s focus on safety and transparency complements our strong dedication to customer excellence and stakeholder trust. Together, we are building solutions that prioritize what matters most to our customers while setting new standards for innovation and resilience,” said Oliver Bäte, CEO of Allianz SE.
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