News | July 30, 2014

Guided Therapeutics Files PMA Amendment With FDA for LuViva Cervical Scanner

Guided Therapeutics PMA Amendment FDA LuViva Cervical Scanner

July 30, 2014 — Guided Therapeutics Inc. has filed an amendment to its premarket approval (PMA) application with the U.S. Food and Drug Administration (FDA) for the LuViva Advanced Cervical Scan.

The filing follows the face-to-face meeting the company had with the FDA in May 2014 and addresses questions raised in a Sep. 6, 2013 not-approvable letter that the company received from the agency.

“We believe that our PMA amendment addresses the remaining questions the agency had about our application,” said Gene Cartwright, CEO of Guided Therapeutics. “While we await a decision on the U.S. market, we continue to see momentum building in the larger international market where we are working to increase pilot studies with LuViva, drive sales and build market share.”

The FDA has 180 days to respond to the amendment.

The company has regulatory approval to sell LuViva in Europe with the Edition 3 CE mark, and has marketing approvals from COFEPRIS in Mexico, Health Canada and Singapore Health Sciences Authority, among others. Additionally, expansion efforts are ongoing in the Middle East, Asia and Latin America.

LuViva scans the cervix with light and uses spectroscopy to measure how light interacts with the cervical tissue. Spectroscopy identifies chemical and structural indicators of precancer that may be below the surface of the cervix or misdiagnosed as benign. This technique is called biophotonics. Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory analysis or a tissue sample, and is designed to provide results immediately, which may result in eliminating costly, painful and unnecessary additional testing. LuViva is intended for use with women who have undergone initial screening and are called back for follow up with a colposcopy examination, which in many cases involves taking a biopsy of the cervix. The device is used in conjunction with the LuViva Cervical Guide single-use patient interface and calibration disposable.

For more information: www.guidedinc.com

Related Content

Lunit Unveiling AI-Based Mammography Solution at RSNA 2018
News | Mammography | November 15, 2018
Medical artificial intelligence (AI) software company Lunit will be returning to the 104th Radiological Society of...
Breast Density Advocate Nancy M. Cappello Passes Away

Nancy Cappello. Image courtesy of AreYouDense.org.

News | Breast Density | November 15, 2018 | Jeff Zagoudis, Associate Editor
Imaging Technology News extends its condolences to the family, friends and colleagues of Nancy M. Cappello, Ph.D., who...
Merit Medical Completes Acquisition of Cianna Medical
News | Women's Health | November 14, 2018
Disposable device manufacturer Merit Medical Systems Inc. announced the closing of a definitive merger agreement to...
The MOZART Supra Specimen Tomosynthesis System is the latest generation of 3-D imaging for breast cancer surgery.
News | Breast Imaging | November 08, 2018
KUBTEC announced the launch of a new innovation in the treatment of breast cancer. The Mozart Supra Specimen...
Feature | Breast Imaging | November 07, 2018 | By Jeff Zagoudis
Breast imaging technology has experienced major growth over the last decade or so, and a new report suggests the mark
Philips’ Compressed SENSE technology helps shorten MRI exams by eliminating redundant radiofrequency signals from the acquisition phase. The software reconstructs any missing  information to maintain high image quality. (Images courtesy of Philips/University Hospital Cologne)

Philips’ Compressed SENSE technology helps shorten MRI exams by eliminating redundant radiofrequency signals from the acquisition phase. The software reconstructs any missing information to maintain high image quality. (Images courtesy of Philips/University Hospital Cologne)

Feature | Breast Imaging | November 05, 2018 | By Jeff Zagoudis
The incidence of breast cancer is rising globally, with an estimated 1 in 8 women diagnosed in their lifetime and 40,...
Volpara Enterprise Cloud Reaches 1 Million Mammograms Stored
News | Mammography | October 31, 2018
Volpara Solutions announced that the data stored in the Volpara Enterprise cloud now exceeds 1 million mammographic...
Philips Debuts Integrated Breast Ultrasound Solution
News | Ultrasound Women's Health | October 26, 2018
Philips announced what it calls its ultimate ultrasound solution for breast assessment, available with the Philips Epiq...