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
Rubedo’s RLS-1496 Reduces Actinic Keratosis Pre-Cancerous Skin Lesions by 46% at Four Weeks with Minimal Irritation in Preliminary Results of Phase 1b/2a Study28.5.2026 14:30:00 CEST | Press release
RLS-1496 is an investigational, first-in-class, disease-modifying, selective glutathione peroxidase 4 (GPX4) modulator that targets pathologic senescent and other stressed, aging cells that drive chronic, age-dependent diseases, such as AK, and represents a novel drug category — Adaptive SenoTherapeutics In recognition of May as Skin Cancer Awareness Month, Rubedo is calling attention to the myths and facts surrounding AKs — and to the urgent need for a new generation of treatments that are effective without the side-effect burden of today's options Rubedo Life Sciences, Inc. (Rubedo), an AI-driven, clinical-stage biotech focused on selective cellular rejuvenation medicines targeting aging cells, today announced preliminary results from a Phase 1b/2a study of RLS-1496 in patients with actinic keratosis (AK), a common age-related condition resulting in precancerous skin lesions, that is most commonly seen after age 65.1 The open-label multi-center trial, conducted in the United States,
ExaGrid Wins 5 Industry Awards at Network Computing Awards 202628.5.2026 14:00:00 CEST | Press release
ExaGrid named “Company of the Year” for seventh year in a row ExaGrid®, the world’s largest independent backup storage vendor providing Tiered Backup Storage with the most Comprehensive Security and AI-Powered Retention Time-Lock for Ransomware Recovery, today announced that company was honored with five industry awards, including Air-gapped Ransomware Recovery Product of the Year, Bench Tested Product of the Year, Company of the Year, Data Protection Product of the Year, and the Storage Product of the Year during the Network Computing Awards ceremony, held in London on May 21, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260528849813/en/ The ExaGrid team headed to the stage five times throughout the Network Computing Awards ceremony in London to accept awards for ExaGrid Tiered Backup Storage. Photo courtesy of Network Computing Awards. The Network Computing Awards are determined by public vote. The 2026 awards mark
Ardoq Launches AI-First Enterprise Architecture Platform28.5.2026 14:00:00 CEST | Press release
Custom Agents, Omnipresent AI Assistant, and AI Import Builder Automate an Estimated 40% of Routine EA Work; Tenneco Already Achieving 292% ROI on Ardoq AI Ardoq, named a 5x Leader in the Gartner® Magic Quadrant™ for Enterprise Architecture Tools, today launched its AI-first enterprise architecture (EA) platform. The release grounds every Ardoq AI output in customers' live architecture data and introduces a new generation of AI agents capable of automating an estimated 40% of routine EA work. Architects today are being asked to defend decisions that generic AI is generating in seconds. Application rationalization choices. ERP transformation roadmaps. AI governance reviews. The questions land on the architect's desk, but the analysis underneath increasingly comes from AI assistants that do not know the architecture. Generic agents reason on whatever document is in front of them, not on the live relationships between applications, dependencies, capabilities, and risks. Ask a generic LLM
European DataWarehouse Launches DealDox®, a Next-Generation Virtual Data Room Built specifically for the Securitisation Market28.5.2026 14:00:00 CEST | Press release
European DataWarehouse (EDW) announced today the launch of DealDox®, a secure virtual data room uniquely tailored to the needs of the securitisation and structured finance market. Developed in response to long‑standing challenges around transaction data and document management, DealDox provides a single, secure environment where all parties throughout the deal lifecycle can collaborate efficiently while maintaining high standards of security, governance, and regulatory alignment. DealDox enables the centralised management of transaction data and documentation, offering robust security, granular access controls, and clear audit trails. The platform integrates seamlessly with EDW’s existing regulatory reporting ecosystem, supporting smoother workflows from deal preparation through to disclosure and compliance. “As a market infrastructure, our role is to reduce complexity and make processes simpler and more transparent for all participants,” said Dr. Christian Thun, CEO of European DataWa
SLB and Vår Energi Expand Digital Collaboration to Scale Well and Integrated Field Development Planning28.5.2026 13:47:00 CEST | Press release
Agreement supports Vår Energi’s ambition to reduce time to first oil, building on multi-discipline, collaborative well planning workflows that reduce cycle times from months to days Global energy technology company SLB (NYSE: SLB) today announced an expanded collaboration with Vår Energi to scale well planning and integrated field development planning across its Norwegian Continental Shelf operations. With collaborative well planning already reducing cycle times from months to days and integrated field development planning expected to support similar benefits, the expanded deployment is designed to support faster, more consistent decision-making as operators work to sustain production from mature offshore assets while managing increasing development complexity. As part of the expanded collaboration, Vår Energi is deploying the Delfi™ digital platform to connect exploration, subsurface evaluation, well planning, subsea design, field development planning, and production in a cloud-native
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