Align Technology issues statement on EU proceeding

The European Commission has opened a formal investigation into Align Technology (Nasdaq: ALGN) following a complaint filed by a competitor, the company confirmed in a statement based on the Commission's June 30 announcement.

Align, which makes the Invisalign clear aligner system and iTero intraoral scanners, said the Commission's action is procedural and does not represent a finding of wrongdoing or a conclusion on the merits of the case.

The investigation appears to center on Align's scan acceptance policies related to its iTero intraoral scanning platform. Align said its platform supports an open digital dental ecosystem and that scans generated by iTero devices can be exported to order aligners from competitors other than Invisalign. The company said its scan acceptance policy is designed to ensure clinical quality, patient safety, and system reliability.

Align stated it disputes any suggestion that its practices are unfair and expressed confidence that a review will reflect what it described as a competitive teeth-straightening market. The company said it will cooperate fully with the Commission.

According to the press release, iTero scanners have been used to perform over 24 million restorative, wellness, and orthodontic scans since 2018.

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