Tele: 561.316.3330
Breaking Medical Device News

Monday, September 27, 2021
HomeFDAIbex Granted FDA Breakthrough Device Designation

Ibex Granted FDA Breakthrough Device Designation

Ibex Medical Analytics today announced the granting of Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), which will help fast track the clinical review and regulatory approval of its platform.

Ibex notes the FDA’s Breakthrough Device Designation is granted to technologies that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer. The designation enables close collaboration with, and expedited review by the FDA, and provides formal acknowledgment of the Galen platform’s utility and potential benefit as well as the robustness of Ibex’s clinical program.

Pathologists play a crucial role in the detection and diagnosis of disease, with their assessment being vital for correct treatment decisions in cancer care. However, a rise in cancer prevalence and advances in personalized medicine have resulted in growing diagnostic complexity that significantly increases pathologists’ workloads. Ibex’s Galen platform uses Strong AI algorithms to help pathologists improve the quality of cancer diagnosis, implement real-time quality control, reduce diagnosis time and boost productivity. It has already demonstrated outstanding outcomes in clinical studies and is deployed in labs worldwide where it is used as part of everyday clinical practice.

“Oncology treatments have made great strides, but in order to save more lives it is also essential to see technological advances in cancer diagnostics,” said David Shulkin, MD, former Secretary, U.S. Department of Veterans Affairs and advisor to Ibex Medical Analytics. “Enhancing the accuracy of cancer diagnosis and improving the efficiency for the pathologist is paramount to improving quality and affordability of cancer care. Ibex’s AI platform has demonstrated success in helping pathologists worldwide improve care for patients with cancer. This FDA designation is an important step forward in making this technology broadly available in the United States.”

“We are honored to have been granted the Breakthrough Device Designation. Ibex is committed to providing world class tools for pathologists to ensure every patient receives a timely and correct diagnosis, while supporting pathology labs and health systems to increase efficiency and accuracy,” said Joseph Mossel, Chief Executive Officer and Co-Founder of Ibex Medical Analytics. “Our Strong AI technology is already in clinical use globally, making a real impact on patient care. We are proud to work closely with the FDA and look forward to continuing to collaborate with the agency as we accelerate our clinical program in the United States.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

ProSomnus® Sleep Technologies Adds John E. Remmers, MD, to Leadership Team

Dr. John E. Remmers will provide expert medical and strategic guidance on a range of initiatives, including research and development, regulatory clearances, company strategy, medical education, and clinical investigations.

Nanox to Announce Zebra Medical Vision Secures 8th 510K FDA Clearance for its Coronary Artery Calcium (CAC) Solution as Part of Its Population Health Offering

On August 10th, 2021 Nanox announced that it had entered into an acquisition agreement via merger with Zebra Medical Vision LTD.

Christopher Joyce Joins Miach Orthopaedics as VP & CFO

Christopher Joyce has joined as vice president and chief financial officer, and Kevin Sidow has been appointed to the company’s board of directors.

NGMedical GmbH Receives FDA Clearance for Its AM Titanium Lumbar Interbody BEE® PLIF

The BEE® PLIF cage has been created to benefit from additive manufacturing features. The purposefully designed honeycomb endplate design reduces the risk of subsidence, while allowing fusion.

Recombinant Technologies is Raising Capital to Roll Out a Game Changing Alzheimer’s Treatment

Recombinant Technologies is focused on treating the root cause of Alzheimer's Disease delivering a huge improvement in the quality of life of those afflicted.

Tyber Medical Reaches Agreement to Acquire CatapultMD

Once the acquisition is complete, Tyber Medical will own and operate a combined 100,000-square feet of manufacturing space between its Pennsylvania headquarters and Florida-based facilities.

Kleiner Device Labs Receives FDA Market Clearance for KG2 Surge Flow-Thru Interbody System

The system maximizes total bone graft delivery volume, better distributes graft bilaterally into the intervertebral disc space, and streamlines the implant delivery, positioning, and grafting process for TLIF and PLIF spinal fusion procedures.

Matthew Cranfill New ExtriCARE USA Director Of Clinical Services

"Matt's impressive experience and skillset easily made him our top pick," said Peter Mason, President of ExtriCARE USA.

By using this website you agree to accept Medical Device News Magazine Privacy Policy