Lumendi receives ISO certification — 3 insights

Lumendi received ISO 13485 certification from BSI America, a medical device testing and certification company, for its medical devices.

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Here’s what you should know:

1. The certification recognizes medical device manufacturers for their quality control systems. The certification process emphasizes patient safety, product performance and quality.

2. Lumendi’s flagship product is its DiLumen Endolumenal Interventional Platform. The platform fits over a standard endoscope and gives gastroenterologists enhanced inner colon maneuverability and visibility.

3. Lumendi’s DiLumen received FDA 510(k) clearance in December 2016.

More articles on gastroenterology:
GI leader to know: Dr. Sumanth Daram of Augusta University
Stock market week-in-review for 5 large GI companies — July 24-28
GI center to know: Texas GI Endoscopy Center

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