NICO Corporation Among Early Companies to Successfully Transition to New EU MDR Requirements for Class III Medical Devices

Monumental effort required to meet stricter clinical compliance standards compared to EU MDD

NICO Corporation, an Indianapolis-based pioneer and leader in minimally invasive neurosurgery, announced today it is among early companies to successfully complete transition to the new European Union (EU) Medical Device Regulation (MDR). This regulation is considered to be the most comprehensive and stringent medical device regulation in the world and allows NICO to continue providing its innovative, clinically proven Class 3 medical device products to patients across Europe.

Achieving EU MDR certification is a significant milestone for NICO that included a rigorous process demanding compliance with stricter requirements in quality management systems, manufacturing processes, product design, and clinical data monitoring.
“Our devices encompass the full range of EU classifications, including multiple EU class III products,” said Jay Dittman, Vice President of Operations at NICO Corporation. “The expectations under MDR have set a new standard for medical devices in Europe. Years of planning and preparation were required to handle raised expectations, numerous audits, simultaneous reviews, and challenges with notified body capacity. Our Quality, Regulatory and Engineering team achieved a monumental milestone for NICO.”

NICO’s successful transition to the new regulation demonstrates its commitment to safety and quality in the design, manufacture and distribution of their products and positions the company for continued success in the global medical device market.

“This certification supports our determination to improve clinical outcomes through true minimally invasive neurosurgery that is safe and less traumatic for the patient and more efficient for the neurosurgeon,” said Jim Pearson, president and CEO of NICO Corporation. “We continue to work toward advancing and expanding our product portfolio that offers a complete solution for minimally invasive neurosurgery, as well as enabling improved processing for oncology precision medicine using our novel method of tissue collection and biological preservation.”

NICO is the first and only company in the world to develop and patent technologies to create an entirely new minimally invasive surgical market in neurosurgery for subcortical and skull base lesions. NICO technologies have been featured in more than 180 peer-reviewed publications with over 550 unique authors from major academic centers. Data from these publications suggest improved clinical outcomes in Minimally Invasive Parafascicular Surgery (MIPS).

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.
"Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy," said Henry Shin, CEO of STARmed. "We look forward to our products being made available to more patients through Olympus' global distribution network."
The company reports they have successfully met the six-month primary endpoint for the first-ever female patient implanted with the UroActive™ System, the first smart automated artificial urinary sphincter (AUS) to treat SUI.

By using this website you agree to accept Medical Device News Magazine Privacy Policy