Guided Therapeutics Reports After Meeting with FDA They Will Start Study in Support of its Application for FDA Approval

October 21, 2020

Guided Therapeutics, Inc. announced today the successful outcome of its October 14, 2020 meeting with FDA. The purpose of the meeting was to finalize the protocol (procedure) for its new clinical study in support of its Premarketing Application for the LuViva® Advanced Cervical Scan (i.e., FDA approval).

Guided Therapeutics filed the minutes from this meeting with FDA yesterday, which the agency will review and provide any final comments on the meeting and study protocol.

Currently, women are screened for cervical cancer using one or more laboratory-based tests that require a tissue sample. Women who test positive on these screening tests are referred to biopsy of the suspect cervical tissue. Unfortunately, because of limitations in current imaging technology, 40- 50% of the time the disease is not detected when it is actually present. In addition, the screening tests may generate up to 80% false positives. LuViva does not require a tissue sample and produces an immediate result, so that treatment can begin sooner. Previous clinical studies that included two year follow up showed that LuViva detected a significant number of these missed cases. The Company has received broad agreement from the FDA on the new study’s methodology and patient population in order to demonstrate LuViva’s ability to significantly improve the early detection of cervical cancer. The study is expected to take a few months once enrollment begins and will include approximately 300 to 600 patients.

“Reaching agreement with FDA on the intended use of LuViva and the study to support that intended use is a major milestone for us,” said Gene Cartwright, CEO. “We look forward to filing the protocol with the participating clinical sites and beginning the study as soon as practicable.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Led by researchers at NYU Grossman School of Medicine, the study results add to evidence that neighboring brain regions, the inferior frontal gyrus and the motor cortex, play an important role in such planning before words are said aloud. Both are part of the folded top layers of the brain, or cerebral cortex, which has long been known to control the muscle (motor) movements in the throat and mouth needed to produce speech. Less clear until now was how closely these regions determine the mix of sounds and words people want to say aloud, the authors report.
PolarisAR describes STELLAR Knee as a mixed-reality surgical navigation platform that guides TKA procedures by displaying measured and computed data overlaid directly in a 3D environment. The mixed-reality system acts as a spatial computer, creating continuous data exchange between the surgeon and the software to help enhance surgical decision-making while simplifying operating room workflow.
This February, the first enrolled patient underwent open surgical aortic arch reconstruction at the University of Pennsylvania, Presbyterian Medical Center, Philadelphia, PA.  During the surgery, the Duett Vascular Graft System was successfully deployed to connect the native left common carotid artery to the surgical graft.
"Our ultra low insertion loss Athermal AWG Multiplexers along with temperature-hardened low-drift AAWG specifically designed for the industrial temperature applications will be marketed aggressively through partnership companies in the East Asia and EU regions after its success in the North America," says Dr. Donald Yu, CMO of POINTek, who runs global marketing operations from Los Angeles, California.
AUX-001 is an innovative, once-daily, extended-release formulation of Nicorandil. For decades, immediate-release, twice daily Nicorandil has been a cornerstone treatment for chronic angina symptoms outside the US, distinguished by its dual mechanism of action that targets both the micro- and macrovascular coronary artery flow bed, and providing sustained angina symptom relief without the common issue of tachyphylaxis seen with other anti-anginal vasodilators like long-acting nitrates. AUX-001 offers efficacy comparable to conventional anti-anginal medications such as beta-blockers, calcium channel blockers, and long-acting nitrates while also potentially enhancing control of the underlying coronary disease and reducing angina related hospitalizations.

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