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The European Commission has launched an antitrust investigation into Align Technology regarding suspected tying of iTero scanners to Invisalign products.

Investigation Scope and Allegations

The European Commission announced on Tuesday that it is investigating U.S.-based Align Technology for potential anti-competitive practices within the European Economic Area. The probe focuses on whether the company is unfairly tying its iTero intra-oral scanners to its Invisalign clear aligner systems.

Regulatory authorities are examining whether this practice restricts competition by forcing or incentivizing dental professionals to use the company's proprietary hardware to access its widely used orthodontic products. Tying occurs when a seller makes the sale of one product conditional on the purchase of a second, distinct product, potentially shutting out competitors in the secondary market.

Regulatory Oversight in the EEA

This investigation marks a significant move by EU regulators to ensure fair play within the medical technology and dental sectors. The European Commission holds the authority to penalize companies if they are found to have abused a dominant market position to stifle competition.

If the investigation confirms that Align Technology leveraged its market share in clear aligners to gain an unfair advantage in the scanner market, the company could face substantial fines. Currently, the Commission has not reached any final conclusions regarding the legality of the company's business model or the specific impact on the European dental market.

Industry Impact

The outcome of this probe may influence how medical device manufacturers bundle software and hardware in the future. Key areas of interest for regulators include:

• The compatibility of iTero scanners with third-party orthodontic aligners.
• Whether the integration of Invisalign software creates artificial barriers for other scanner manufacturers.
• The pricing structures used to market the scanner and aligner combination to dental clinics.

Align Technology has not yet issued a formal response to the commencement of this specific antitrust inquiry. The investigation is expected to involve a detailed review of internal company policies and market data provided by dental practitioners across the European Economic Area.