RAQA NEWS ROUND UP (FEBRUARY)

02 February 2020

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IMAGINA Endoscopy System Granted FDA Approval

The IMAGINA endoscopy system created by Hoya Group's Pentax Medical unit has been awarded 510(k) clearance by the FDA.

The system, which was designed to aid in gastrointestinal (GI) procedures at outpatient and ambulatory surgery centres, will allow for better visualisation and improved user experience with an enhanced interface and design. The device features a high resolution (1080p) LCD touch screen and Pentax i-SCAN real-time and digital image enhancement technology.

David Woods, CEO and President of Pentax Medical Americas said: The launch of the IMAGINA allows us to best serve the needs of the core GI market and our system provides maximum cost predictability without compromising on the standard of care delivered to patients.

IMAGINA eliminates the costliest components of a premium GI endoscopy system and still adheres to the highest imaging standards in the industry: a true testament to our commitment to better patient outcomes, improved patient experience and a lower overall cost of care.”

Retrievable Stent System Wins FDA Breakthrough Status

Reflow Medical’s retrievable stent system, Temporary Spur Stent System, has be awarded breakthrough device designation by the FDA.

The technology, designed to treat below-the-knee (BTK) peripheral artery disease, has a system of retrievable stents consisting of expandable spikes that can create several paths for drugs to be delivered into the vessel wall, without causing any lasting damage.

Reflow Medical's CEO Isa Rizk said: “We are extremely grateful to the FDA for their expedited designation of the Temporary Spur Stent System as a Breakthrough Device. We plan to take full advantage of the Program’s benefits, accelerating our efforts towards meeting the requirements of the review process as we advance this novel technology, with the goal of improving the lives of patients.”

Stethoscope AI Algorithms Given FDA Approval

The FDA has awarded 510(k) clearance to digital stethoscope developer Eko for its artificial intelligence algorithms.

The AI technology is designed to be used with the company's Duo stethoscope and will help medical professionals determine if atrial fibrillation (AFib) and heart murmurs are present during physical examinations.

In studies, the algorithm detected AFib with 99% sensitivity and 97% specificity and Heart murmurs with 87% sensitivity and 87% specificity.

“Our vision since day one has been to build seamless technology that helps providers more accurately detect heart disease, the leading killer in the world, by putting the ears of a cardiologist in any clinician’s stethoscope,” says Eko’s Co-Founder and CEO, Connor Landgraf “Eko’s new ability to alert a provider to the presence of a heart murmur or atrial fibrillation during the standard physical exam brings that vision to life.”

Transcatheter Mitral Valve Replacement Device Wins EU Approval

Abbott has announced its transcatheter mitral valve implantation system, Tendyne, has gained CE Mark approval.

The device, which is designed to treat mitral valves that are too damaged to repair, or to treat high risk patients unable to undergo open heart surgery, is delivered via a minimally invasive procedure and implanted directly into the patient's heart, replacing the damaged mitral valve.

Michale Dale, Senior Vice President of Abbott's structural heart business said “The launch of the Tendyne device builds upon our history of developing ground-breaking therapies that offer new treatment options for people with serious structural heart conditions who have limited treatment options. The availability of Tendyne as a treatment option in Europe provides physicians with an additional tool that has been shown to completely correct MR in very ill patients, and it adds to Abbott's portfolio of life-changing and life-saving treatments.”

The company hopes to eventually gain FDA approval and is currently conducting clinical trials in the US.