FDA

FDA “First” Approvals: Pediatric Lens for Myopia and Duodenoscope with Disposable Elevator

By MedTech Intelligence Staff
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FDA

CooperVision, Inc. and Pentax of America won the agency approvals, respectively.

Last Friday FDA announced two first-of-its-kind approvals.

CooperVision, Inc. received FDA approval for MiSight, the first contact lens intended to slow the progression of myopia in children between 8 and 12 years old. Also known as nearsightedness, myopia is the most common cause of correctable visual impairment around the world. MiSight is a single use, disposable and soft contact lens that is meant to be worn every day.

MiSight is a revolutionary product that can make a meaningful difference in the lives of children needing visual correction,” said Al White, president and CEO of CooperVision in a press release. “Today’s approval is a big step forward for the ophthalmic industry as eye care professionals finally have an approved treatment for slowing the progression of myopia rather than just providing glasses or contact lenses to mask the condition.” White called the growing incidence of myopia a “global epidemic”.

As part of the approval, CooperVision must conduct a postmarket study of MiSight to further evaluate product safety and effectiveness.

Pentax of America received FDA clearance for the first duodenoscope that has a sterile, disposable elevator component that reduces how many parts must be cleaned and reprocessed between each product use. The Pentax Medical Video ED34-i10T2 duodenoscope is used in conjunction with endoscopic devices to provide visualization and access to the upper gastrointestinal tract.

“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” said CDRH Director Jeff Shuren, M.D., in an FDA release. “Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients in the U.S. We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other health care facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess. Today’s clearance is another step in the FDA’s ongoing effort to advance the development and availability of safer duodenoscopes.”

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