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ClearPoint Neuro Announces First EU MDR Certification Success and Approval to Ship Product to Europe
SOLANA BEACH, Calif., Jan. 22, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene
About this update from Clearpoint Neuro Inc.
[{"type":"text","content":"SOLANA BEACH, Calif., Jan. 22, 2024 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced receipt of European Medical Device Regulation (EU MDR) clearance for the manual SmartTwist® MR Hand Drill and SmartTip® MR Drill Kit. Additionally, the Company received updated certification from its Notified Body allowing for shipment of products manufactured at its new Carlsbad, California facility to Europe. European Medical Device Regulation 2017/745 (EU MDR), the new medical device regulation applicable in Europe, replaces the previous Medical Device Directive 93/42/EEC (MDD) regulation. With the introduction of EU MDR, the EU is placing greater emphasis on safety measures, risk management, post-market surveillance, and data collection of medical devices for companies who wish to obtain European market access. “EU MDR is much more rigorous than MDD, forcing many medical device companies in our space who wish to enter or continue commercialization in Europe to closely assess every product before committing the time and resources necessary to meet its requirements,” stated Megan Faulkenberry, Vice President of Quality at ClearPoint Neuro. “Our team has risen to this challenge, especially given the importance of the EU to our pharmaceutical partners.” About ClearPoint Neuro ClearPoint Neuro is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company’s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical/biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company’s field-based clinical specialist team, which offers support and services to our customers and partne...