Northeast Scientific Achieves 510(k) for IVUS Catheter reprocessing

Awl-in-One Tap (Next-Generation) Granted U.S. Patent Reports EDGe Surgical

Awl-in-One Tap is a single-use spinal surgery instrument with disposable neuromonitoring EMG system and digital depth measurement built in. The device, which is under development, is intended to be used when creating a screw hole pathway during posterior pedicle spinal fusion surgeries.

Healthcare Safety Preparedness Post-Covid-19: Protection from Violence and Virus

If the nation has learned anything from the Covid-19 crisis, it’s that advance planning in safety preparedness is vital to our ability to respond to emergencies, whether they’re viral, violent, or otherwise.

June 23, 2020

Northeast Scientific Inc., this week announced it has received FDA clearance for reprocessing the .014 Digital IVUS catheter.

Northeast Scientific notes this is the second 510(k) the Connecticut-based company has been awarded for the reprocessing of the IVUS type catheter.

While crediting his team in their work addressing the FDA requirements to win the 510(k), CEO Craig Allmendinger went on to say; “By adding the .014 IVUS to our existing portfolio of products, we are positioned to be the key resource for any OBL Physician focused on keeping costs down while never compromising on patient safety”.

 “Adding the .014 in conjunction with the ongoing R&D 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”, closed Allmendinger.

The company has said that it will have an additional announcement soon regarding when the .014 device will be available for sale.

With an unparalleled record for quality and safety across their 15 years of business, Northeast Scientific has reprocessed over 650,000 devices.





Related Articles