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June 22, 2020
Northeast Scientific Gains FDA Clearance for IVUS Catheter Reprocessing
June 23, 2020—Northeast Scientific Inc. announced it has received FDA 510(k) clearance for reprocessing a .014-inch digital intravascular ultrasound (IVUS) catheter. The company advised it will soon announce commercialization plans for the .014 device.
This is the second FDA clearance the company has been awarded for the reprocessing of the IVUS catheter.
The company’s CEO Craig Allmendinger commented in the announcement, “By adding the .014 IVUS to our existing portfolio of products, we are positioned to be the key resource for any office-based lab physician focused on keeping costs down, while never compromising on patient safety.” He continued, “Adding the .014 in conjunction with the ongoing [research and development] projects we are working on for other devices, Northeast Scientific is going to continue to separate itself as the world leader in reprocessing for the peripheral vascular market.”
Based in Waterbury, Connecticut, Northeast Scientific has been in the business of reprocessing medical devices for 15 years. More information about the company’s products is available on the company website.
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