Under the European antitrust microscope, in an action that for the first time touches the medical devices sector, is Align Technology, the US company that revolutionized orthodontics with the Invisalign brand, suspected of hindering competition by linking its transparent aligners to the exclusive use of iTero intraoral scanners.
BRUSSELS TIGHTENS THE SCREWS
The European Commission has launched a formal antitrust investigation to verify whether Align Technology abused its dominant position in the European Economic Area.
The investigation, triggered by a competitor’s complaint, hypothesizes that the US company implemented a forced tying strategy between Invisalign transparent aligners and iTero intraoral scanners. This procedure assumes historic relevance as it represents the first case in which competition rules are formally applied to a sector, that of medical devices, previously monitored only regarding public procurement.
Teresa Ribera, Executive Vice-President of the Commission, emphasized that the goal is to preserve fair markets for the benefit of citizens’ health.
PRACTICES TO CLOSE THE ECOSYSTEM
At the heart of Brussels’ suspicions is conduct aimed at creating a closed digital ecosystem that would limit the freedom of choice of dental professionals.
The Commission is particularly analyzing Align’s refusal, starting in 2017 coinciding with the expiration of some key patents, to approve third-party scanners for the automated submission of Invisalign orders. Furthermore, the company allegedly systematically rejected scans generated by competitors’ devices, despite these being based on file formats compliant with industry standards. Such measures could have artificially protected iTero scanners from competition, exploiting the market leadership of Invisalign aligners to induce dentists to adopt the manufacturer’s entire technological suite.
THE COMPANY’S RESPONSE
In an official statement, Align Technology described the opening of the European proceeding as a purely procedural act, clarifying that it does not constitute a finding of guilt nor a formal accusation.
The company rejected any hypothesis of wrongdoing, declaring that it operates with integrity and in full compliance with competition laws. Management also defended the open nature of the iTero platform, asserting that scans can be exported for the purchase of aligners produced by third parties.
Reiterating that its success derives from innovation and the quality of the experience offered to doctors and patients, the US giant assured constructive cooperation with the European Commission throughout the investigative process.
THE REVOLUTION OF ALIGN TECHNOLOGY
Founded in 1997 in Redwood City by five employees, Align Technology radically transformed orthodontics by introducing the Invisalign system in 1999, a method based on removable transparent plastic aligners. The company, which today is headquartered in Tempe, Arizona, expanded its technological offering in 2011 with the acquisition of Cadent and its iTero scanners.
Thanks to a database of over 22 million patients treated globally, the company operates through the Align Digital Platform, a complex architecture integrating advanced 3D modeling, biomechanics, and large-scale 3D printing. With a presence in more than 100 markets, the company has served so far approximately 299,500 doctor clients worldwide.
GOVERNANCE AND RECENT ECONOMIC SUCCESSES
Since 2015, the company has been led by Joseph M. Hogan, Chairman and CEO with a background leading GE Healthcare and ABB. The management team includes John F. Morici as CFO, Julie Coletti as head of legal and regulatory affairs, and David Carr, Managing Director for the EMEA area, responsible for operational management in the European territory.
On the financial front, in the first quarter of 2026 Align Technology reported record revenues of $1,040.1 million, up 6.2% year-on-year. Invisalign aligner shipments reached 685,700 units in the quarter, driven by strong international demand. These performances enabled the company to generate a net profit of $112.8 million and to confirm a share repurchase program for an additional $200 million.
