The European Union has opened an antitrust investigation to determine if Align Technology violated competition rules with its intraoral scanners and clear aligners.
Here are eight things to know:
- Align Technology’s iTero intraoral scanners are used by dental professionals to create 3D digital scans of patients’ teeth, which are then used to create clear aligners, according to a June 29 news release from the European Union.
- The investigation focuses on Align Technology’s refusal to approve competing scanners for the automated submission to Align of digital scans for Invisalign orders since 2017, and refusal to accept dental professionals’ submissions of scans generated by other intraoral scanners.
- The EU has expressed concerns that Align Technology may have “unfairly leveraged” its Invisalign clear aligners by having dental professionals needing to purchase their intraoral scanners to order the aligners.
- Article 102 of the Treaty on the Functioning of the European Union (TFEU) and Article 54 of the European Economic Area (EEA) Agreement prohibit the abuse of a dominant position that may affect trade and prevent or restrict competition.
- The company’s scan acceptance policy is designed to ensure clinical quality, patient safety and system reliability, according to a June 30 news release from Align Technology.
- Scans generated by iTero scanners can be exported to order aligners other than Invisalign aligners.
- Since 2018, the iTero scanner has been used by healthcare professionals to perform over 24 million restorative, wellness, and orthodontic scans.
- “Align Technology is committed to conducting business with integrity and in full compliance with global competition laws,” the company said in the release. “We believe fair, lawful competition drives innovation, expands choice, and delivers better outcomes for doctors and patients. Our success in the teeth-straightening market is built on the strength of our products and services — quality, innovation, and customer experience — not on unfair practices, and we strongly dispute any suggestion to the contrary.”
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