The Medical Device Business Journal — Medical Device News & Articles | MassDevice
MASSDEVICE ON CALL — Diagnostics maker Menssana Research is making promising progress with a breath-test that the company says can identify at-risk breast cancer cases in just 6 minutes.
In a study of nearly 250 women at 3 centers in New Jersey, Washington and the Netherlands the test was able to accurately identify women with early stage breast cancer or with abnormal mammogram, Menssana said.
Seno Medical is inching to its $39 million fundraising objective, having brought in $34.6 million in its Series C equity funding round.
San Antonio-based Seno has been at this for some time, and for this round has brought in MedCare Investment Funds as a lead investor. The funding is going towards the company’s U.S. pivotal study of the Imagio breast imaging device, as well as chasing CE Mark approval in Europe.
VuComp said it won 510(k) clearance from the FDA for its M-Vu breast density tool, which provides automated assessment of breast density from a digital mammogram.
The M-Vu uses advanced computer vision algorithms to evaluate the appearance of structures and textures in the breast to differentiate between fatty and dense regions. It then calculates a percentage of breast area that is dense, translating it to 1 of 4 density categories corresponding to the BI-RADS standard.
MASSDEVICE ON CALL — The FDA cautioned women last week not to use nipple aspirate tests as a replacement for mammograms or other tests for breast cancer.
The federal watchdog agency said the aspirate tests, which draw fluid from the breast through the nipple, "an determine whether the fluid collected from the breast contains any abnormal cells."
Seno Medical Instruments touted the 100th patient enrolled in a pivotal clinical study of the company’s Imagio system, an opto-acoustic breast imaging platform designed to help prevent unnecessary biopsies.
Intact Medical closed a $4 million equity funding round in support of its breast biopsy systems, the company revealed in regulatory filings.
The Framingham, Mass.-based device maker listed 11 unnamed investors who participated in the round.
German medical device maker BioCer this week touted regulatory wins in the U.S. and in the U.K. for devices in its TiO2Mesh line, including for its mastectomy bra and hernia repair mesh.
By Tom Ulrich
MASSDEVICE ON CALL — Double mastectomy rates have doubled over the last 10 years, including some women who’ve opted to remove a healthy breast after discovering early-stage breast cancer in the other, but the extreme measure may not be doing them much good.
