Siemens’ fortunes in women’s health have taken a turn for the better since the company released its full-field digital mammography (FFDM) system. Only a few months after the FDA approved its Novation FFDM, Siemens executives were animated about the product.
Siemens' fortunes in women's health have taken a turn for the better since the company released its full-field digital mammography (FFDM) system. Only a few months after the FDA approved its Novation FFDM, Siemens executives were animated about the product.
"We have made tremendous progress with a number of key customers and new customers as well," said Erica Rouleau, Siemens national sales director for women's health. "The competition is really seeing us for the first time in our full glory."
The Novation received FDA premarket approval in August, making Siemens the fourth manufacturer to bring an FFDM system to market. The product, which supports digital screening, diagnosis, and stereotactic biopsy, features a flat-panel amorphous selenium detector and offers the potential to provide higher spatial resolution and greater clinical detail than other systems, according to the company.
Siemens expects to ship about 30 Novation systems by the end of the year. At $450,000 each, that translates into about $13.5 million in income, not a bad start for a system that has been on the market only since August. Its success, however, was anything but a slam dunk. GE Healthcare, Hologic, and Fischer Imaging all had a big head start in the field. But that's not how Siemens execs saw it.
"It doesn't matter when you come out," Rouleau said. "You can be number one to market and a few years later be playing catch up."
Being fourth rather than first to market was an advantage, she said.
"We had the luxury of time, and we've used that time to learn. The mammography machine and the mammography department are not islands anymore. Now, the vendor has a bigger job: to network, to be integrated within the HIS/RIS, and to allow multiple doctors to read soft copy," she said.
An example of how Siemens benefited from its competititors' perceived "mistakes" is the Novation's larger detector size of 24 x 29 cm. GE's FFDM detector measures 19 x 23 cm. On the downside, Siemens still has to catch up with GE's full-field digital mammography market share.
Aiding that battle is MammoReport, a dedicated workstation for mammography, which supports high-volume mammogram reading and optimized workflow. Its dedicated keypad and roaming/panning function optimize spatial resolution while allowing users to switch images among eight-view mammographic studies in less than one second. MammoReport is also designed to accommodate digital CAD applications.
These capabilities are appealing, but there's more to the Siemens pitch than just technology. Customers can look at their purchase as an investment in a corporate partner, Rouleau said.
"They'll be partnering with a multimodality company that has a vested interest in women's healthcare," she said. "We've demonstrated our willingness to invest money and people in this technology. We have the total package of image quality, image receptor, workflow, and integration into the network."
FDA Clears New Features in AI-Powered Mammography Software Suite
October 11th 2024Therapixel’s MammoScreen suite has received 510(k) FDA clearances for a breast density assessment feature and updated software that includes automated pre-reporting, which reportedly expedites reporting of mammography findings.