RAQA NEWS ROUND UP (JANUARY)

12 January 2020

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FDA Breakthrough Status for Bionic Pancreas

Beta Bionics' automated bionic pancreas has been awarded FDA Breakthrough Device Designation.

The device, the iLet Bionic Pancreas System, is a small wearable device capable of controlling blood sugar levels autonomously. It behaves similar to an insulin pump and can monitor sugar levels without the user needing to manually enter carbohydrates, isulin delivery information.
Designed as a three in one solution, the device can be programmed as an insulin bionic pancreas, a glucagon bionic pancreas or can be set for both insulin and glucagon.

Ed Damiano, president and CEO of Beta Bionics, said: “We believe the iLet Bionics Pancreas System represents a true breakthrough therapy for the management of glycemia, particularly in type 1 diabetes. We are particularly excited by the possibility that the iLet may be able to provide safer and more effective therapy in far more people than current therapies due to its simplicity of use.”


FDA Breakthrough Status for Robotic Surgical System

Vicarious Surgical announced it has gain FDA Breakthrough Device Designation for it's robotic surgical device.

The device has been designed for use in minimally invasive procedures and in conjunction with modern virtual reality technology to essentially "to shrink the surgeon and put them inside the patient.”

“We are the first surgical robot to be recognized with the FDA’s breakthrough classification,” Vicarious CEO & co-founder Adam Sachs said in a news release. “This validates the platform we are developing and the clinical value it can offer surgeons and patients. It also adds to our momentum as we advance our innovative technology toward commercialization.”

Heart Pump Implant Procedure wins FDA Approval

Abbott’s HeartMate 3 heart pump has gained FDA approval for use in less invasive heart pump implant procedures in a bid to reduce open heart surgery in patients.

“We continue to focus on advancing our heart failure devices and techniques to make life better for the patients we serve. The first approved LVAD HeartMate. It was approved more than 25 years ago. Since that time, the technology has evolved immensely." said Abbott Mechanical Circulatory Support medical director Robert L Kormos.

"Today’s HeartMate 3 device, including its design and size, allows physicians to successfully implant it without having to perform open heart surgery and offers survival rates, as demonstrated in the MOMENTUM 3 clinical trial, at two-years that are comparable to heart transplants.”

The HeartMate 3 heart pump can be used with the HeartMate 3 LVAD via a lateral thoracotomy resulting in an easier recovery than open heart surgery.


FDA Approval for Bone Conduction Implant

Cochlear's bone conduction hearing system implant, Osia 2, has been awarded FDA approval.

The system works by bypassing the damaged parts within the ear and sending vibrations through the bone and to the cochlear.

Cochlear acoustics clinical affairs director Mats Dotevall said: “We aimed to leverage Cochlear’s long history of innovation in both the cochlear implant and bone conduction implant spaces to create something entirely new.

“Rather than implanting a conventional electromagnetic transducer, we chose to work with piezoelectric material because of its unrivalled suitability for this type of implanted application. Lifetime testing shows Piezo Power technology provides powerful and consistent performance over time.”