Le Lézard
Classified in: Health, Science and technology
Subjects: PDT, TRI, PLW, IMA

Esaote Obtains EC MDR Certification for the New Magnifico Open Total-Body Magnetic Resonance System


The New European Union Medical Devices Regulation (MDR), Regulation (EU) 2017/745, Came Into Force on May 26th, 2021

GENOA, Italy, Nov. 30, 2021 /PRNewswire/ -- Esaote ? a leading Italian company in the biomedical sector, in ultrasound, dedicated magnetic resonance imaging and information technology for healthcare ? is pleased to announce that the new Magnifico Open total-body magnetic resonance system has obtained EC MDR certification.

The new certification attests to the Magnifico Open system's compliance with the requirements of the new European Union Medical Devices Regulation (MDR), Regulation (EU) 2017/745, which entered into force on May 26th, 2021. 

The new regulation, replacing Directive 93/42/EEC on medical devices (MDD) and others, was implemented by the European Parliament to improve the EU approval system for medical devices, by imposing strict requirements on both manufacturers and Notified Bodies involved in the conformity assessment of those devices.

The MDR certification for the Esaote Magnifico Open was issued by the internationally recognized TÜV SÜD certification body, one of the first Notified Bodies in the world to receive authorization to provide certification according to the new regulation.

The evaluation criteria in the new Regulation include more precise and rigorous requirements in terms of the content and scope of the technical documentation required for medical devices and for manufacturers' Quality Management Systems; for clinical assessments and investigations, especially the type, purpose and quality of clinical data; for product evaluation and after-sales surveillance, which must be guaranteed at all times.

"We're very proud that our new Magnifico Open total-body magnetic resonance system meets the strict regulatory requirements of the MDR," noted Massimo Polignano, Chief Quality Officer at Esaote. "It is a highly complex process, one we engaged in immediately at the same time as in the process to develop the system itself. It is a new milestone, acknowledging Esaote's constant commitment to bring safe and reliable diagnostic systems to the market, with the utmost respect for the health and protection of users and patients, on whom our everyday work is always focused."

Magnifico Open ? which adds to the range of Esaote products unveiled in 2021 ? is an open magnetic resonance system with the latest technology. The wide choice of receiver coils and state-of-the-art MRI technology offer the user excellent image quality, while the permanent magnet makes it easy to use and lowers operating costs. The open magnet and the easy-to-access patient table also facilitate, speed up and make patient positioning more comfortable, ideal for both the claustrophobic and for children.

Esaote

The Esaote Group is a leader in the biomedical equipment sector, especially ultrasound, MRI, and medical diagnosis software. It currently has approximately 1,180 employees. With facilities in Genoa and Florence, and production and research units in Italy and the Netherlands, the company has offices in over 100 countries across the world. www.esaote.com

Photo - https://mma.prnewswire.com/media/1698974/Esaote_magnifico.jpg
Logo - https://mma.prnewswire.com/media/1653938/esaote_Logo.jpg


These press releases may also interest you

at 21:42
LatAmGrowth SPAC (the "Company") announced today that it priced its initial public offering of 13,000,000 units at $10.00 per unit. The units will be listed on the Nasdaq Global Market (the "Nasdaq") and trade under the ticker symbol "LATGU"...

at 21:05
Samsung Electronics Co., Ltd., a world leader in advanced semiconductor technology, today introduced its new fingerprint security IC (integrated circuit) ? S3B512C ? with enhanced security features. The new solution is EMVCo and Common Criteria...

at 20:45
TransPerfect, the world's largest provider of language and technology solutions for global business, today announced that it has been named a winner of the 15th annual Grand Stevie Awards. The Grand Stevie is the highest honor of the Stevie Awards®...

at 20:43
OpsVeda, the leading provider of Operations Management Systems, today announced that it has achieved the Service Organization Control (SOC) 2 Type II certification. The certification is the result of extensive evaluation by an American Institute of...

at 20:14
The Blockchain-based Service Network (BSN) today announced that the BSN Decentralized Digital Certificate (BSN-DDC) Network (ddc.bsnbase.com), an infrastructure dedicated to Non-Fungible Token (NFT) adoption in China, has soft-launched with eight...

at 20:01
Yosi Health, a provider of digital patient scheduling, registration, payment, and communication cloud-based software solutions, announced today they have added Hants Williams, PhD, RN, a professor at the State University of New York (SUNY) at Stony...



News published on 30 november 2021 at 07:39 and distributed by: