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Press Release

Trice Medical Receives FDA 510(K) Clearance for mi-eye 2

Trice Medical
Posted on: 06 Oct 16

PR Newswire

KING OF PRUSSIA, Pa., Oct. 6, 2016

KING OF PRUSSIA, Pa., Oct. 6, 2016 /PRNewswire/ -- Trice Medical announced today that it received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for mi-eye 2, a disposable needle with a fully integrated camera that enables physicians to use advanced diagnostic imaging to visualize joint injuries in their clinic. The mi-eye 2 is designed for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The mi-eye 2 also provides physicians the ability to inject or aspirate under direct visualization.

The mi-eye 2 is Trice Medical's second, next-generation FDA-cleared patented technology, which includes improvements that significantly enhance the mi-eye's resolution, field of view, depth of field and overall visualization.

"Based on feedback we received from our surgeon advisory board, we promptly implemented and pursued FDA clearance for the next-generation mi-eye 2," said Jeffrey O'Donnell, Sr., President and CEO at Trice Medical. "Our team made dramatic enhancements to the technology of the mi-eye, which reflects our continued commitment to patients by introducing our technology into a medical practice, and working to ensure that the mi-eye technology becomes the standard of care for providing an immediate real-time diagnosis. Our long-term goal is to eliminate the need for MRI exams and enable a quicker road to recovery."

The Need for New Diagnostic Technology

Currently there are approximately 28,000 orthopedic surgeons seeing 20 million office visits annually for knee-related problems. In addition, there are 12 million visits annually related to shoulder pain. MRI's are often inconclusive, or result in false readings, which has the potential to lengthen the timeline from diagnosis to recovery. In addition, not every patient is a candidate for MRI. The mi-eye 2 provides a diagnostic modality for every patient, and can provide time-savings to the patient by eliminating the multiple visits associated with an MRI. The mi-eye 2 is unlike any other in-office arthroscopy device on the market today, and provides unparalleled optics with the ease of use of a needle.

About Trice Medical

Trice Medical was founded to fundamentally improve orthopedic diagnostics for the patient, physician, and payor by providing instant, eyes-on, answers.  Trice has pioneered and evolved, fully integrated camera-enabled technology that provides a clinical solution optimized for the physician's office. Trice's mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system. Trice Medical's investors include Safeguard Scientifics (NYSE: SFE), BioStar Ventures and HealthQuest Capital. For more information, visit www.tricemedical.com; follow us on Twitter, LinkedIn and Facebook; or call 844.643.9300.

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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/trice-medical-receives-fda-510k-clearance-for-mi-eye-2-300340164.html

SOURCE Trice Medical

PR Newswire
www.prnewswire.com

Last updated on: 06/10/2016

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