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VuComp Inc.

Ex-Neuronetics, Abiomed exec is Intact Vascular’s new CEO | Personnel Moves

July 15, 2014 By Brad Perriello Leave a Comment

Ex-Neuronetics, Abiomed exec is Intact Vascular's new CEO | Personnel Moves

Intact Vascular said yesterday that it named medical device veteran Bruce Shook as its new president & CEO.

Filed Under: News Well Tagged With: American Diabetes Assn., Arch Therapeutics, Intact Vascular, intersectent, Medigus Ltd., Personnel Moves, Philips, Precision Optics Corp., Spiracur, Tearlab Corp., VuComp Inc.

Press Release: VuCOMP Announces FDA Approval of M-Vu Computer-Aided Detection (CAD) for Mammography Version 3.1

June 11, 2014 By MassDevice Leave a Comment

Press Release: VuCOMP Announces FDA Approval of M-Vu Computer-Aided Detection (CAD) for Mammography Version 3.1

Filed Under: Food & Drug Administration (FDA), Mammography, News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Women's Health Tagged With: Breast Cancer, Press Release, VuComp Inc.

VuCOMP lands FDA nod for updated M-Vu mammography system

June 11, 2014 By Arezu Sarvestani Leave a Comment

VuCOMP lands FDA nod for updated M-Vu mammography system

Cancer detections systems maker VuCOMP announced this week that it won FDA approval for new computer-aided detection software, launching version 3.1 of its M-Vu CAD for mammography.

Filed Under: Food & Drug Administration (FDA), Mammography, News Well, Pre-Market Approval (PMA), Regulatory/Compliance, Women's Health Tagged With: Breast Cancer, VuComp Inc.

VuComp wins FDA clearance for breast density measurement tool

December 24, 2013 By Chris Walker Leave a Comment

VuComp wins 510(k) clearance for breast density measurement tool

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.

Filed Under: News Well, Oncology, Regulatory/Compliance Tagged With: Breast Cancer, VuComp Inc.

Breast cancer: VuCOMP wins expanded PMA for digital mammogram analysis

October 18, 2012 By MassDevice staff Leave a Comment

breast cancer digital mammogram

Medical imaging analysis devices maker VuCOMP touted FDA premarket approval for its new M-Vu system for helping radiologists detect breast cancer earlier.

The Version 2 M-Vu system’s new indication allows the company to market its devices as an computer-aided detection adjunct to digital mammography.

Filed Under: Food & Drug Administration (FDA), Mammography, News Well, Pre-Market Approval (PMA) Tagged With: Breast Cancer, VuComp Inc.

Medtronic lands FDA clearance, plans launch for next-gen CRM lead | Regulatory Roundup

January 30, 2012 By MassDevice staff Leave a Comment

Medtronic logo

Medtronic Inc. (NYSE:MDT) landed FDA clearance for its DF4 high-voltage right ventricular lead for use with implantable cardiac rhythm management devices.

The DF4, which builds on Medtronic’s Sprint Quattro lead, aims to help simplify the implantation process with a redesigned port and by providing visual confirmation of the lead’s connection to the device.

Filed Under: 510(k), News Well, Pre-Market Approval (PMA) Tagged With: Applied Spectral Imaging, Baxano Surgical, Baxter, Cardiac Rhythm Management, CardioKinetix Inc., Charter Medical, Covidien, Cynosure Inc., Positron Corp., Systagenix Wound Management Inc., VuComp Inc.

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