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FDA Clearance Granted to QT Ultrasound® for New Breast Imaging Device
QT Ultrasound LLC has received 510(k) clearance from the U.S. Food and Drug Administration to market its Transmission Ultrasound breast scanner. The company’s Transmission Ultrasound technology generates high fidelity 360 degree images of the breast with excellent image clarity. The elimination of radiation and breast compression make the QT scan™ an important additional breast imaging tool for physicians and the women they treat; at this time it is not intended as a replacement for screening mammography.
John Klock, M.D., founder and CEO of QT Ultrasound, explains that the company’s recent publications have shown that Transmission Ultrasound technology is especially useful in visualizing detailed breast anatomy.
The company has initiated a broad-ranging clinical trial program designed to evaluate whether Transmission Ultrasound technology can (1) aid in the reduction of call-back and false-positive biopsy rates; and (2) replace screening mammography. “Our clinical trials are progressing to help us answer these important questions and learn how this new technology can make a difference in women’s health,” added Dr. Klock.
About QT Ultrasound
QT Ultrasound is a privately held company engaged in the research, development, and commercialization of Transmission Ultrasound technology. Their research has been supported by over $16 million in funding from the Cancer Imaging Program of the National Cancer Institute of the US National Institutes of Health. The company’s clinical trials have been conducted at many prestigious institutions in the US and Europe and it is currently enrolling women in trials at the Marin Breast Health Trial Center in Novato, California.
Zebra gets CE mark for medical image analyzing algorithms
Zebra Medical Vision has received a CE mark for its medical image analysis technology. The system uses algorithms to uncover evidence of fatty liver, coronary artery calcium, emphysema and other indicators of disease in CT scans.
Shefayim, Israel-based Zebra is set to introduce the product in the European Union on the back of securing the CE mark. The offering currently includes five algorithms designed to detect fatty liver, excess coronary calcium, emphysema, low bone density and vertebral compression fractures. Zebra plans to introduce more than 10 more algorithms in the coming months.
All the algorithms are underpinned by the same model. An anonymized database of medical images and clinical data is the foundation of the approach. Zebra has used this resource to train algorithms to detect and analyze certain markers in medical images. In the case of fatty liver, the algorithm segments and calculates the average density of the liver using CT scans of the chest and abdomen. The bone density algorithm delivers bone density T-scores from CT scans.
Zebra sees the automation of these tasks helping overstretched radiology departments.
“We see significant interest in countries that have a problematic ratio of radiologists per capita. Providing tools that assist them in delivering better care is critical,” Zebra CEO Elad Benjamin said in a statement. “We have already begun working with luminary university hospitals in Europe, and will continue to expand our footprint across the region.”
Zebra laid the groundwork for its expansion in Europe by working with the Parisian public hospital system and other healthcare facilities in the region. The company has now also gained regulatory clearance to start pushing the product in Australia and New Zealand.
Those clearances mean Zebra is now positioned to market its technology in countries with the sort of “problematic” numbers of radiologists its system is designed to support. In the United Kingdom, for example, growth of CT and MRI scans is outsripping increases in the number of radiologists. The number of radiologoists increased by 5% from 2012 to 2015, according to the Royal College of Radiologists. The number of CT and MRI scans increased by 29% and 26%, respectively, over the same period.
Such trends are hindering the ability of radiology departments to scan patients and analyze images in a timely manner. Zebra thinks it can help by providing algorithms to take up slack created by the shortage of radiologists. The technology is designed to integrate into picture archiving and communication systems (PACS), radiological information systems (RIS) and electronic medical record (EMR) systems.
Zebra has advanced to this point using $20 million in funding from investors including Intermountain Healthcare, Khosla Ventures and Salesforce founder Marc Benioff.
For Further Information
More on the breast imaging market in the US can be found in a report series published by iData Research entitled the US Market for Female and Neonatal Diagnostic Devices. The reports cover: bone densitometry, DXA markets, breast biopsy devices, core needle devices, vacuum-assisted breast biopsy devices, breast imaging equipment, mammography, obstetrics and gynecology ultrasound equipment, fetal and neonatal monitoring devices, infant warmer and incubators, NICU, and gynecological chairs.
Full reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about breast imaging market data or procedure data, register online or email us at [email protected] for a US Market for Female and Neonatal Diagnostic Devices report series brochure and synopsis.
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