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Align Technology Gets FDA Nod for iTero Intraoral Scanner

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Align Technology, Inc. ALGN received the FDA 510(k) clearance for its iTero Element 5D Imaging System for commercial launch in the United States. The iTero Element 5D Imaging System broadens its existing portfolio of high-precision, full-color imaging and speeds up scan times of the iTero Element intraoral scanner.

The regulatory go-ahead is likely to help bolster the company’s iTero scanner and services business segment.

More about iTero Element 5D Imaging System

It is equipped with improved clinical technology, optimized orthodontic and restorative dental workflows. Moreover, the iTero Element 5D Imaging System visualization tools offer a higher quality of patient engagement and communication by enabling them to understand their current dental health, treatment options. This facilitates better patient education, engagement, and compliance during treatment.

The iTero Element 5D Imaging System effortlessly merges three key scanning technologies viz. 3D data, intra-oral color photos and NIRI images into one integrated scan.



Market Prospects

Per Allied market research, the global intraoral scanners market was valued at $273 million in 2016 and is projected to reach $557 million by 2023, witnessing a CAGR of 10.7% from 2017 to 2023. Hence, the regulatory clearance comes at an ideal time.

Recent Developments

Lately, Align technology has been taking steps to strengthen its iTero scanner and services business segment.

In this line, the company recently inked a deal to acquire Germany-based privately held exocad Global Holdings GmbH. exocad is a global pioneer in the dental CAD/CAM software space and specializes in offering fully-integrated workflows to dental laboratories and practices.The acquisitionis likely to bolster Align Technology’s digital platform that provides innovative tools, and features for diagnostic, restorative, implant and orthodontic workflows. Once the acquisition is completed, exocad’s expertise in restorative dentistry, implantology, guided surgery and smile design will be integrated into Align Technology’s portfolio of Invisalign and iTero digital solutions.

Price Performance

In the past six months, the stock has lost  7.6% compared with  a 32.7% decline of its industry.

Zacks Rank and Key Picks

Currently, Align Technology carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are ResMed Inc. RMD, Medtronic plc MDT and Hill-Rom Holdings, Inc HRC.

ResMed has a projected long-term earnings growth rate of 12%. It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Medtronic’s long-term earnings growth rate is estimated at 7.4%. The company presently carries a Zacks Rank #2.

Hill-Rom’s long-term earnings growth rate is estimated at 11.1%. It currently carries a Zacks Rank #2.

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