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
Samsung and Mistral AI Announce Strategic Partnership for Intelligence-Driven Semiconductor Infrastructure8.9.2026 18:15:00 CEST | Press release
Collaboration will focus on development and implementation of on-premises AI technologies across Samsung’s chip operationsSamsung makes lead investment in Mistral’s funding round Samsung Electronics Co., Ltd., today announced it has entered into a strategic partnership with Mistral AI to enhance its semiconductor engineering and manufacturing capabilities that will reinforce its leadership in AI chip technologies. The announcement of the partnership was made during the state summit held in Paris between South Korea and France. Under the agreement, Samsung will integrate Mistral’s AI services and solutions—including its flagship large language model, Mistral Large—across its semiconductor operations to develop customized on-premises AI models optimized for intelligence-driven infrastructure. Mistral’s powerful AI platform is expected to provide Samsung with a unique stack of tools that will transform how semiconductors are designed and manufactured. The on-premises enterprise solutions
Sensereo Airo Wins IFA Berlin Innovation Award8.9.2026 17:00:00 CEST | Press release
Prestigious Accolade Recognizes Sensereo’s Next-Generation Approach to Creating Healthier, Smarter Indoor Environments Sensereo, an environmental intelligence company developing next-generation sensing products for safer, healthier and smarter living, was presented with the prestigious IFA Berlin Innovation Award for its Airo modular indoor air quality system. The award was presented during IFA Berlin on Thursday, Sept. 4, recognizing Airo for its innovative approach to helping consumers better understand and manage the quality of their indoor environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260906292649/en/ Winner of a 2026 IFA Innovation Award, Airo is Sensereo’s flagship environmental intelligence platform, combining advanced sensing technology with a modular design that allows users to monitor multiple aspects of indoor air quality and environmental conditions through a single, consumer-friendly system. Desig
Verdantis Rebrands as the AI Super-Agent for MRO, Sets Sights on AI-Native Enterprise Asset Management8.9.2026 16:06:00 CEST | Press release
Nine AI agents now run the MRO decision chain for Fortune 500 plants; new tagline “Anticipate. Resolve. Learn.” Verdantis, the AI company for spare parts and MRO inventory optimization in asset-intensive industries, today unveiled its new brand identity as the AI Super-agent for MRO and announced it is building toward a fully AI-native Enterprise Asset Management (EAM) platform. Verdantis’s super-agent orchestrates nine specialized AI agents across the decisions that decide plant uptime: spare parts, criticality, demand, reorder, and work order planning. These decisions set working capital, maintenance spend, and whether a critical asset runs and, in most plants, they are still made in spreadsheets and disconnected systems. The positioning is for the teams who own uptime - maintenance, reliability, and MRO supply chain leaders in oil and gas, mining, utilities, chemicals, and manufacturing. And it reflects an AI-first architecture: agents decide and act by default; people supervise, ov
HyperLight Welcomes VentureTech Alliance to Series C, Deepening TFLN Integration Across the Semiconductor Ecosystem8.9.2026 16:00:00 CEST | Press release
HyperLight Corporation ("HyperLight"), a leader in thin-film lithium niobate (TFLN) photonics, today announced that VentureTech Alliance ("VTA") has joined its Series C financing round. VTA is a venture investment firm focused on the semiconductor industry, with a portfolio built across the semiconductor technology stack — including circuit design, foundry-adjacent process technology, EDA, advanced packaging, and photonics. VTA's participation extends the ecosystem alignment that defined the round, which brought together investors spanning silicon ICs, foundry manufacturing, electronics manufacturing services, networking, and global infrastructure capital. With VTA's addition, the syndicate now reaches further into the semiconductor manufacturing and design-enablement layers on which high-volume photonics production depends. "The transition to TFLN is not a component decision — it is an ecosystem decision," said Mian Zhang, CEO of HyperLight. "Getting TFLN into volume requires the proc
EcoOnline Appoints Conor O’Loughlin as CEO8.9.2026 16:00:00 CEST | Press release
O’Loughlin brings founder, product and commercial experience spanning startup growth, global SaaS scale and M&A EcoOnline, a global provider of software that transforms how organisations protect people and the planet, today announced the appointment of Conor O’Loughlin as Chief Executive Officer, effective immediately. O’Loughlin succeeds Tom Goodmanson and will lead the Company into its next chapter of growth and innovation, continuing EcoOnline’s mission of keeping employees safe across the globe and supporting more than 11,000 customers. O’Loughlin is an experienced, growth-oriented technology operator and founder. He co-founded fitness technology company Glofox, scaling it into a global SaaS business serving customers in more than 80 countries before its acquisition by ABC Fitness in 2022. Following the acquisition, he served as Platform President and later Global Chief Revenue Officer at ABC Fitness, leading strategy across the company’s revenue-generating activities. “Keeping peo
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