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
International Human Rights Lawyer Jared Genser and Former White House Counsel Lanny J. Davis Join Legal and Advocacy Team Supporting Cambodian Businessman Yim Leak, Seiden Law LLP Announces18.9.2026 19:52:00 CEST | Press release
Jared Genser, one of the world's most recognized international human rights lawyers, and Lanny J. Davis, an adviser to former presidents George W. Bush and Bill Clinton, join the legal and advocacy team for Cambodian businessman Yim Leak and challenge what they call a coordinated smear campaign in Thailand. International human rights lawyer Jared Genser and Lanny J. Davis, who has close ties to two former US presidents and a worldwide reputation for defending those under attack with lies and smears, and for repairing the damage done to their reputations, have joined the legal and advocacy team supporting Cambodian businessman Yim Leak, Seiden Law LLP, which serves as Yim Leak's chief global counsel, announced today. Their first move is to hold the Thai government accountable, framing its conduct as either complicit in or willfully blind to a sustained smear campaign against Yim. Genser is Managing Director of Perseus Strategies, an international law firm. Over more than two decades, he
Ningbo FEED Meeting Confirms Full Confidence in Q1 2027 FID for Allied Biofuels’ US$6.1 Billion Presidential Decree-Backed SAF and e-SAF Project18.9.2026 17:38:00 CEST | Press release
Allied Biofuels has held a major Front-End Engineering Design (FEED) meeting at Sinopec’s office in Ningbo, China, bringing together Allied Biofuels, Sinopec Engineering Group Co., Ltd. of China, Topsoe A/S of Denmark, Sasol South Africa Limited, and Plug Power of the United States — the principal international engineering and technology providers supporting its US$6.1 billion Presidential Decree-backed Sustainable Aviation Fuel (SAF) and e-SAF project in Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918708077/en/ FEED Meeting - Ningbo, China At the joint FEED meeting of the project’s core engineering and technology stakeholders, the discussions established clear alignment on engineering responsibilities, technology interfaces, design deliverables, project integration and the coordinated execution programme required to advance the project through FEED. All stakeholders working on the project expressed full co
Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli® (Relacorilant)18.9.2026 14:00:00 CEST | Press release
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) should approve relacorilant, combined with the chemotherapy drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer. The CHMP’s recommendation is based on positive data from Corcept’s Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant combined with nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel alone. The safety profile of relacorilant plus nab-paclitaxel in these trials was consistent with the safety profile of nab-paclitaxel monoth
Enhertu® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer18.9.2026 14:00:00 CEST | Press release
Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 Daiichi Sankyo and AstraZeneca’s Enhertu has the potential to become a new standard of care in this early breast cancer setting Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2 targeted treatment. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast05 phase 3 trial presented at th
CHMP Recommends EU Approval of New Indication for Alfasigma’s Jyseleca® (filgotinib), Treatment of Adults With Axial Spondyloarthritis18.9.2026 12:58:00 CEST | Press release
The information contained within this press release is for the purpose of scientific exchange.It is intended for scientific, financial and investor media only.If approved, Jyselecawill be indicated for the treatment of patients with active axial spondyloarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have responded inadequately to conventional therapy.Despite the availability of multiple treatment options, nearly half of people living with axSpA do not respond adequately to current therapies, and just 10-20% reach inactive disease within 16-24 weeks of initiating treatment.CHMP’s positive opinion is based on findings from the OLINGUITO Phase 3 study, where improvements in the signs and symptoms of axSpA with filgotinib were observed early and maintained over 52 weeks of treatment.Jyselecais already approved in Europe and the United Kingdom, for the treatment of moderate to severe rheumatoid arthritis and ulcerative colitis. Alfasigma S.p.A, a global
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