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BioWorld - Monday, May 12, 2025
Home » Keywords » Align Technology Inc.

Items Tagged with 'Align Technology Inc.'

ARTICLES

Regulatory front

ITC kicks complaint by Align Technologies

Nov. 20, 2020
By Mark McCarty
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: J&J subsidiary agrees to settle off-label promotion allegations; FDA says ‘vulnerabilities persist’ in limited CDS programs.
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3-25-Align-itero-element-5d.png

FDA OKs Align Technology’s Itero Element 5D dental scanner

March 25, 2020
By Meg Bryant
San Jose, Calif.-based Align Technology Inc. has won the FDA’s nod for its Itero Element 5D imaging system. The company said the Itero Element 5D is the first intraoral scanner with near-infrared imaging (NIRI) technology that visualizes the internal structure of the tooth in real time. The FDA cleared the device for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.
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