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
Arboris Capital Selects ROYC to Expand Private Markets Capabilities on CapGain Platform18.5.2026 09:00:00 CEST | Press release
Arboris Capital Limited (“Arboris”), a DIFC-based firm arranging alternative investments, authorised by the Dubai Financial Services Authority (DFSA), today announced that it has selected ROYC AB (“ROYC”), a private markets technology and infrastructure provider, to support the continued development of its private markets offering through its platform, CapGain. In its ongoing efforts to expand its private markets capabilities across the Middle East, Arboris has undertaken a strategic review of how to further scale its offering while maintaining the integrity of its existing platform. As a result, Arboris has chosen to integrate ROYC’s fund access, sourcing, and structuring capabilities into CapGain, complementing its existing infrastructure. CapGain is Arboris’s proprietary investment platform, purpose-built to facilitate access between international private market opportunities and Professional Investors in the region. CapGain provides fully digital investor onboarding and KYC, a secu
OdysseyRe Announces New Co-Chief Underwriting Officers for EMEA18.5.2026 09:00:00 CEST | Press release
Odyssey Reinsurance Company (OdysseyRe) today announced the appointments of Tegwen Gromellon and Anne-Claire Serres as co-chief underwriting officers of its EMEA division, effective July 1. They succeed longtime Chief Underwriting Officer, Gaël Le Païh, who is retiring later this year following 36 years with the Company. Based in Paris, Serres joined OdysseyRe in 2018 as the market director for France and will lead the division’s business across France, Africa and the Middle East. Gromellon, who joined OdysseyRe in 2004, has served as market director for Germany, Austria, Benelux and Switzerland since 2019. He will take the lead for the rest of Europe, including the relationship with the Company’s representative office in Stockholm for the Nordic markets and across Turkey. “We are delighted to appoint both Tegwen and Anne-Claire to these important leadership positions,” said Isabelle Dubots-Lafitte, chief executive officer of EMEA for OdysseyRe. “These appointments recognize their sign
LogicMonitor and Deutsche Telekom Expand Partnership Across Europe18.5.2026 09:00:00 CEST | Press release
Expanded availability of LogicMonitor within Deutsche Telekom’s managed services portfolio follows successful operational use in the UKSelect outcomes include reduced reporting times and proactive incident preventionExpansion extends across DACH, Benelux, and the Nordics LogicMonitor®, the AI-first platform for Autonomous IT, today announced the expanded availability of its platform within Deutsche Telekom’s managed services portfolio across selected European markets, including DACH, Benelux, and the Nordics. The expansion builds on operational use of LogicMonitor in the United Kingdom since 2023, where it has supported Deutsche Telekom’s service teams in improving visibility across network, cloud, and hybrid infrastructure environments. Experience gained from these deployments is now informing broader service enablement across additional European markets. As enterprise IT environments grow more complex, organisations require more than visibility—they need predictive resilience. Throug
Prokarium Reports Positive Interim Data from Phase 1/1b PARADIGM-1 trial of ZH9 in NMIBC patients, Demonstrating Excellent Safety and Encouraging Early Efficacy18.5.2026 09:00:00 CEST | Press release
ZH9 is very well tolerated with a favourable safety profile, and no dose-limiting toxicities or Grade ≥3 drug-related adverse events reported.ZH9 demonstrates 91% freedom-from-relapse in NMIBC patients who have reached study end.Company plans to run a larger phase 2 study across a range of patient populations spanning intermediate risk and high risk including CIS. Prokarium, a clinical-stage biopharmaceutical company pioneering bacterial immunotherapies for the treatment of solid tumours, today announced safety and antitumour efficacy results from an interim review of the ongoing Phase 1/1b PARADIGM-1 trial of ZH9 in non-muscle invasive bladder cancer (NMIBC) patients. These data were shared via an oral podium presentation at the American Urology Association (AUA26) Annual Meeting. Prokarium CMO, Dr Josefin-Beate Holz said “These data demonstrate ZH9 as a universally applicable treatment for patients. As the treatment is very well tolerated and is showing impactful outcomes for early a
VahatiCor Appoints Harry D. Rowland, Ph.D., as Chief Executive Officer18.5.2026 08:00:00 CEST | Press release
Endotronix co-founder and former CEO joins VahatiCor as the company advances the A-FLUX Reducer System® and the SERRA-I early feasibility study VahatiCor, Inc., a medtech company developing interventional therapies for Coronary Microvascular Dysfunction (CMD), announced today the appointment of Harry D. Rowland, Ph.D., as Chief Executive Officer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260517830314/en/ VahatiCor CEO, Harry D. Rowland, Ph.D. Rowland previously served as Chief Executive Officer and President of Endotronix, where he led the development and commercialization of the Cordella™ Pulmonary Artery Sensor and Heart Failure System. Under his leadership, Endotronix raised over $150 million and grew to more than 150 employees. He also oversaw the PROACTIVE-HF pivotal trial from execution through FDA premarket approval and commercial launch. Following its acquisition by Edwards Lifesciences in 2024, Rowland stayed o
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