Showing posts with label Hologic Inc. Show all posts
Showing posts with label Hologic Inc. Show all posts

Monday, December 10, 2018

Hologic launches multipurpose Omni-Hysteroscope


Hologic announced the launch of its FDA cleared, innovative 3-in-1 Omni™ Hysteroscope equipped with advanced visualization capabilities to streamline the diagnostic and therapeutic procedures.

The scope comes with 3 interchangeable sheaths which eliminate the physician need to change the scope between diagnostic and treatment procedures. Additionally, the scope is armed with Premium MyoSure optics to ensure clarity and quality visualization throughout the procedure.

The patients experience less pain and discomfort because the scope can be easily inserted because of thin sheaths (3.7 mm diagnostic sheath; 5 mm operative sheath; 6 mm operative sheath). It also provides long 200 mm working length to efficiently work with obese patients.

The sheaths are compatible to use with Hologic’s Fluent™ hysteroscopic fluid management system and all MyoSure® tissue removal offerings including MyoSure REACH, MyoSure XL, MyoSure LITE, and MyoSure MANUAL devices.

“Experts agree that direct visualization of the uterine cavity in women with abnormal uterine bleeding is the gold standard that allows physicians to accurately identify and collect quality samples and remove pathology – in a safer and more effective manner than blind biopsy and curettage,” said Edward Evantash, M.D., Medical Director and Vice President of Global Medical Affairs, Hologic. 

“Featuring three easily interchangeable sheaths in one scope, our new Omni scope gives physicians excellent visualization capabilities with the convenience of seeing and treating pathology in a more streamlined procedure,” he added.  

Tuesday, August 21, 2018

Hologic unveils Fluent fluid management system that simplifies and streamlines hysteroscopies


Hologic launches its new Fluent™ fluid management system to streamline the liquid distention of the uterus during diagnostic and operative hysteroscopy and measure the volume of irrigation fluid in and out of the uterus.

The system is easy to set-up and the user-friendly interface prompts the operator through all the steps to set-up and wraps the operation. The screen provides large visual and audible alerts during monitoring of fluid deficit, pressure, low fluid bags, and full waste bags to keep the procedure running smoothly.

The system is sensitive enough to detect a change in average intrauterine pressure of less than 1% and fluid deficit within +/- 50 mL when running the MyoSure® system. A single waste bag eliminates the need of multiple canisters.

"We developed the Fluent system with a deep understanding of the hectic workflow that often characterizes the patient and staff experience," said Sean Daugherty, President of GYN Surgical Solutions, Hologic. "This launch is a testament to how our strong customer partnerships and unique technological innovations enable us to provide healthcare professionals with the advanced equipment they need to improve lives."

"Fluid management plays a vital role in gynecological procedures, yet there have been few advances in the technology," said Edward Evantash, M.D., Medical Director and Vice President of Global Medical Affairs, Hologic. "The Fluent system is changing the game in fluid management. Developed in response to the challenges facing nurses and doctors performing hysteroscopies, it combines a streamlined design with innovative technology for more efficient fluid monitoring during procedures."

Here is a video about how the Fluent system untangles your fluid management experience



Wednesday, November 29, 2017

FDA clears Hologic’s Quantra 2.2 Breast Density Assessment Software during routine screening mammography


Hologic Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Quantra 2.2 Breast Density Assessment Software. The software helps radiologists and clinicians to provide information about breast density to women during routine breast cancer screenings.

Quantra standardizes breast density reporting and helps eliminates the visual subjectivity by radiologists, through a proprietary algorithm powered by machine learning. The software classifies the breast tissue into four density categories based on  ACR Breast Imaging Reporting and Data System( ACRBI-RADS®) Atlas 5th Edition, based on the distribution of fibroglandular tissue  and texture of breast tissue.

The BI-RADS® Atlas provides standardized breast imaging findings terminology, report organization, assessment structure and a classification system for mammography, ultrasound and MRI of the breast.

The Quantra software is compatible with Hologic's 3D Mammography systems, including the new 3Dimensions mammography system, which is designed to be the fastest, highest resolution breast tomosynthesis system ever, with the 'Intelligent 2D imaging technology'.

Nearly 40% of women between the age of 40 and 74 have dense breasts, which can make it difficult to detect breast cancer during annual screenings and necessitates additional imaging, resulting in increased patient anxiety and unnecessary facility costs. Perhaps most importantly, women with very dense breasts are four to five times more likely to develop breast cancer than women with less dense breasts.

The software is one of several groundbreaking products that is available for demonstration in Hologic's booth (#4705) at the ongoing 103rd ScientificAssembly and Annual Meeting of the Radiological Society of North America (RSNA) at McCormick Place in Chicago from Nov. 26 to 30.

Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions said, "As the global leader in breast cancer screening technology, we relentlessly pursue the development of clinically superior products that address the unmet and changing needs of our customers and their patients, especially when it comes to breast density. Quantra software is yet another example of our dedication and we are proud to feature it – along with a number of other new, breakthrough products – for the world's leading radiologists at RSNA this week."

Earlier this year, FDA approved its Genius 3D Tomosynthesis Mammography as the only test superior to 2D mammography for routine breast cancer screening for women with dense breasts. 

Hologic also commercially launched its SmartcCurve breast stabilization system at the same time, that makes mammography experience less painful for women without compromising on image quality and diagnostic accuracy.

Hologic Worldwide Quantra Volumetric Breast Density Assessment