EU opens antitrust probe into Align Technology’s Invisalign sales practices
Brussels opened its first medical devices antitrust case, testing whether Align tied Invisalign orders to iTero scanners across Europe.
The European Commission opened a formal antitrust investigation into Align Technology on Tuesday, examining whether the U.S. company tied its iTero intra-oral scanners to Invisalign clear aligners across the European Economic Area. The case, triggered by a competitor complaint, is the bloc’s first formal antitrust probe in medical devices and could shape how far Brussels is willing to go against platform-style control in digital dentistry.
Regulators are focusing on whether dentists and orthodontists were effectively required to buy or use an Align scanner to order Invisalign treatment for patients. The Commission is also testing whether Align refused scans from rival scanners or made access to Invisalign conditional on scanner use, a tactic that would let the company use its strength in aligners to reinforce its scanner business. The inquiry has no announced deadline, and any finding against Align could lead to changes in sales practices, interoperability rules and customer access across Europe.
The stakes are commercial as well as regulatory. Align reported fiscal 2025 revenue of $4.0 billion, including $3.2 billion from clear aligners and $789.6 million from systems and services. By the end of 2025, the company said it had more than 22 million Invisalign patients worldwide, more than 121,000 active iTero scanner units and more than 295,000 Invisalign-trained doctors. Its annual report says the digital workflow is built around proprietary software embedded in iTero scanners, ClinCheck, ClinCheck Pro, the Invisalign Doctor Site and Align X-Ray Insights, and that those products are not sold separately.
That tightly linked model is central to the competition case. Align built its business around a vertically integrated chain that combines scanning, treatment planning and aligner production, a structure that can be difficult for rivals to match once dentists are locked into one system. The company also continues to expand that ecosystem abroad, announcing a new multi-million-dollar manufacturing facility in Hyderabad, India on May 22 and hosting 400 doctors at its 2026 Invisalign EMEA Ortho Summit in Barcelona on May 21.
Teresa Ribera, the European Commission’s competition chief, has said clear aligners have transformed orthodontic care for millions of Europeans and that the investigation reflects the bloc’s commitment to fair markets in healthcare. For Align, the immediate risk is not a finding of guilt but a long investigation into whether its sales strategy crosses the line from successful integration into abuse of dominance.
This article was produced by Prism’s automated news system from verified source data, official records, and press releases, then run through automated quality and moderation checks before publishing. The system is built and supervised by the people who set the standards it runs under. Read our full AI policy.
Did this article answer your question?
