- MedTech firm RxSight, Inc. ( NASDAQ: RXST ) announced that the U.S. Food and Drug Administration (FDA) notified the company on June 30 that the agency required additional information for the approval of its lower-cost-to-manufacture Light Delivery Device (LDD).
- LDD — used with the company’s light adjustable intraocular lenses (LAL) as needed — is a machine used in cataract surgery.
- The company intends to provide the additional information to the FDA and plans to obtain approval for the device without any impact on the timeline for its commercial launch.
- Commercial sales of lower-cost-to manufacture LDD, which has a functionality similar to the currently marketed LDD product, is not planned until 2023, RxSight ( RXST ) reiterated.
- Read: RxSight ( RXST ) posted a strong revenue beat with its financials for 1Q 2022.
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RxSight says FDA requires additional info for approval of light delivery device