Hologic wins FDA 510k for Quantra 2.2, inks dev & distro deal with Clarius

Hologic (NSDQ:HOLX) said recently that it won FDA 510(k) clearance for its Quantra 2.2 breast density assessment software and that it inked a development and distribution deal with Clarius Mobile Health for its wireless, handheld ultrasound scanner.

The Marlborough, Mass.-based company said the Quantra 2.2 software uses a proprietary algorithm to analyze mammography images for the distribution and texture of breast tissue to produce patient-specific breast density assessments.

“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,” Hologic breast and skeletal health solutions division prez Pete Valenti said in a prepared statement.

The company’s Quantra software is designed to be used with its 3D mammography systems including its new 3Dimensions system which it touts as the fastest, highest resolution breast tomosynthesis system.

Hologic said today that it inked a development and distribution deal for Clarius Mobile Health’s wireless, handheld ultrasound scanner, though financial terms of the agreement were not disclosed.

“We’re very excited to partner with a company that places the same value on image quality and accuracy as we do here at Hologic. The exceptional image quality and portability of Clarius’ ultrasound system, coupled with our industry-leading deep learning algorithms, bring us one step closer to ensuring all women have access to the breast care they need and deserve,” Valenti said in a prepared release.

Earlier this month, Hologic saw shares stay steady after the medical device maker posted fourth quarter and full fiscal year 2017 earnings that topped expectations on Wall Street.

The post Hologic wins FDA 510k for Quantra 2.2, inks dev & distro deal with Clarius appeared first on MassDevice.

from MassDevice http://ift.tt/2hVid15