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
OpenRouter Raises $113 Million CapitalG-led Series B as Weekly Volume Explodes to 25T Tokens26.5.2026 15:15:00 CEST | Press release
NVentures, ServiceNow Ventures, MongoDB Ventures, Snowflake Ventures, Databricks Ventures join CapitalG, a16z, Menlo Ventures, and others in backing the high-growth AI infrastructure startup OpenRouter, the AI model exchange, today announced a $113 million Series B led by Alphabet’s independent growth fund, CapitalG, with participation from investors including NVentures (NVIDIA’s venture capital arm), ServiceNow Ventures, MongoDB Ventures, Snowflake Ventures, Databricks Ventures, alongside existing investors including Andreessen Horowitz and Menlo Ventures. OpenRouter’s volume has surged to 25 trillion tokens per week (100 trillion tokens per month), representing a 5X increase from the 5 trillion tokens processed per week just six months ago. The explosion in token demand illustrates how quickly enterprises are deploying agents and scaling AI across multiple models and providers. OpenRouter’s infrastructure manages and optimizes inference and provides access to 400+ models across leadi
Xsolla Expands Its Community Management Tools for Creators, Community Leaders, and Resellers26.5.2026 15:00:00 CEST | Press release
Xsolla Adds New Features For Creators, Community Leader Experience, And Distinct Channels For Emerging Markets Xsolla, a leading global video game commerce company, today announced three simultaneous expansions of its community management tools and products. As the creator economy continues to reshape how games are discovered and the industry accelerates its shift toward direct-to-consumer commerce, Xsolla is building on its community management tools for creators, community leaders, and emerging markets, and will showcase them at TwitchCon Rotterdam later this month. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260526596720/en/ Graphic: Xsolla The games industry has never had a shortage of people who drive player acquisition, loyalty, and commerce; it's had a shortage of infrastructure that recognizes them. Creators stream it. Community leaders build a culture around it. Local resellers get it into the hands of players in
Biocytogen Launches AI-Powered RenSuper™ Platform and Industry-First Fully Automated Antibody Discovery Infrastructure26.5.2026 14:00:00 CEST | Press release
Biocytogen today announced the launch of RenSuper Workstation, a next-generation AI-powered antibody discovery platform providing off-the-shelf access to a large-scale, experimentally validated library of fully human therapeutic antibody sequences, together with the RenSuper High-Throughput Antibody Manufacturing Automation Center, a fully automated infrastructure designed to accelerate antibody validation and production. Built on Biocytogen’s proprietary RenMice® platforms, RenSuper establishes a closed-loop antibody discovery engine combining in vivo immune repertoires, AI-driven candidate selection, automated experimental validation, and scalable manufacturing infrastructure. The platform supports the discovery and development of monoclonal antibodies, bispecifics, multispecifics, antibody-drug conjugates (ADCs), VHHs, and other advanced therapeutic modalities, significantly reducing the time and risk associated with antibody discovery. RenSuper Workstation: AI-Powered One-Click Tar
ViaLase Announces Global Commercial Introduction of the FLIGHT Procedure26.5.2026 14:00:00 CEST | Press release
First commercial femtosecond laser image-guided, high precision trabeculotomy (FLIGHT) treatments mark a new era in interventional glaucoma; one where precision, safety, and the patient experience define the new standard of care ViaLase, Inc., a commercial stage medical technology company pioneering incision-free, laser-based solutions for glaucoma, today announced the successful completion of the first commercial FLIGHT procedures performed at Centre for Sight in London by Sheraz Daya, MD, and Gus Gazzard, MD, and at Breyer, Kaymak & Klabe Augenchirurgie in Düsseldorf, Germany, by Karsten Klabe, MD. The first commercial FLIGHT procedures were performed using the ViaLuxe® Laser System to deliver an incision-free, image-guided femtosecond laser treatment designed to create precise channels through the trabecular meshwork to restore aqueous outflow and reduce intraocular pressure in patients with open-angle glaucoma. “Centre for Sight has always been committed to bringing meaningful inno
BioIVT to Spotlight ADME-Tox Expertise and Solutions at Summer 2026 Events26.5.2026 14:00:00 CEST | Press release
Company will demonstrate how high-quality, well-characterized biospecimens are critical to the success of both new approach methodologies (NAMs) and traditional studies BioIVT, the leading biospecimen solutions provider and global research partner for drug and diagnostic development, today announced it will showcase its broad portfolio of ADME-Tox solutions and research expertise at several leading industry events, including the 2026 MPS World Summit and the ISSX 16th European Meeting. The MPS World Summit takes place May 26-May 29, 2026, in Washington, D.C. BioIVT colleagues will be available at booth #115 to discuss research questions and needs, including preparation, handling, and utilization of the high-quality tissues and cells needed for microphysiological systems (MPS), as well as conducting ADME studies and bioanalysis. BioIVT offers an extensive range of control and disease state biospecimens, including SPHEROID CERTIFIED™ Hepatocytes as well as advanced HEPATOPAC® co-cultures
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