RAQA NEWS ROUND UP (NOVEMBER)

24 November 2019

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Contact Lens to Slow Myopia in Children Given FDA Approval

The FDA has given premarket approval to the CooperVision MiSight lens for the treatment of myopia (near-sightedness) in children. The single use soft lens, designed to slow the progression of the eye condition in children aged 8-12 years, was trialled in 135 children over a period of 3 years. The results showed that the myopia progression in children who wore the MiSight lenses was less than in those children who wore conventional soft lenses. It was also found that the axial length of the eye at yearly check-ups showed less change in those wearing the MiSight lenses.

Malvina Eydelman, director of the Office of Ophthalmic, Anaesthesia, Respiratory, ENT and Dental Devices within the Center for Devices and Radiological Health said "this is the first FDA-approved product to slow the progression of myopia in children, which ultimately could mean a reduced risk of developing other eye problems”

When worn, the MiSight contact lens corrects the refractive error and improves distance vision in near-sighted eyes the same way corrective lenses would. However, with MiSight lenses, concentric peripheral rings in the lens also focus part of the light in front of the retina and thus reducing the stimulus causing the myopia progression.

The lenses are already available in UK, Canada, Spain and Australia and hope to launch in the US in March 2020.

FDA Clears Duodenoscope with Disposable Part

In a bid to cut down on infection rates the FDA has approved the Pentax Medical Video ED34-i10T2, the first duodenscope to have a sterile and disposable elevator component. The component, which accesses to the bile and pancreatic ducts and helps to position endoscopic instruments during procedures, is known to be a difficult part of the device to clean and reprocess.

Jeff Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological Health said “Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,”. He also added that improving duodenoscope safety is a “top priority” of the agency and called on healthcare providers to make the switch to easier-to-reprocess duodenoscopes with disposable components.

Breakthrough Approval for AI Gastric Cancer Diagnostic

The FDA has granted Breakthrough Device Designation to AI Medical Service's artificial intelligence based gastric cancer diagnostic algorithm. The machine learning algorithm is able to analyse images from endoscopy procedures and determine the potential presence of gastric cancer.

The Japanese start up announced in October that it had raised $42.9 million in a Series B funding round and is currently in the process of obtaining approval in its original country as well continuing to work through the approval processes in the US and other countries around the world.

Dr. Tomohiro Tada, CEO of AI Medical Services, says, "We will launch this ground-breaking technology approved by the FDA as soon as possible in the US market.
As our founding philosophy states, we plan to contribute to endoscopic medical treatment around the world."

FDA Approval for Hands Free Robotic System

The FDA has given clearance for XACT Robotics hands free robotic system for the use in computed tomography (CT) guided percutaneous interventional procedures. The device is the first of its kind, combining image-based navigation tools to guide instruments to a specified location in the body.

XACT Robotics founder, executive chairman and president Harel Gadot said: “We are committed to redefining the way the entire medical community utilises robotics, beginning with interventional radiologists. He added “Being the first to introduce a hands-free robotic system, we have the potential to provide significant clinical, technical and economic value while democratising interventional procedures.”