Invisalign Maker Align Denies Wrongdoing, Defends Competition Practices As Europe Launches Probe

The European Commission on Tuesday launched a formal antitrust investigation into Align Technology Inc. (NASDAQ: ALGN ) to determine whether the medical device company abused its market position by tying the use of its Invisalign clear aligners to its iTero intraoral scanners across the European Economic Area.

The iTero intraoral scanner is a digital 3D dental impression system used to capture precise images of teeth and oral tissue.

Align said the probe is procedural, denied any wrongdoing, and said it complies with applicable competition laws.

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The regulator is assessing whether Align leveraged Invisalign’s market position by effectively requiring dental professionals to use iTero scanners to order its clear aligners.

The Commission’s review centers on Align’s interoperability policies.

Specifically, the Commission is examining whether, since 2017, Align has refused to approve competing scanners for the automated submission of digital scans used in Invisalign orders.

It is also investigating whether the company declined to accept scans generated by rival scanners even when they used industry-standard file formats.

According to the Commission, those practices may have created a closed ecosystem around Invisalign, potentially insulating iTero scanners from competition while reinforcing Align’s position in the clear aligner market.

Align Defends Competition Practices In a response issued Tuesday, Align said it conducts business with integrity and complies with global competition laws.

The company added that product quality, innovation, and customer experience— not unfair business practices —drive its market position.

Align said its iTero platform supports a broad digital dental ecosystem and allows users to export scans for aligners other than Invisalign.

The company added that it designed its scan acceptance policy to ensure clinical quality, patient safety, and reliable processing through validation requirements.

Align also noted that healthcare professionals have performed more than 24 million restorative, wellness, and orthodontic scans using iTero since 2018.

The company said the Commission’s action is a procedural step to collect information and does not represent a finding of wrongdoing.

Align added that it will cooperate fully with the investigation and remains confident that its scanner and scan acceptance policies comply with competition laws.

ALGN Stock Price Activity: Align Technology shares were at $168.66 during premarket trading on Wednesday, according to Pro data.

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