Faster, more comfortable exams with high image quality and accurate interpretations are what providers are looking for in the breast imaging space. Equipment and software manufacturers are focusing on just that with their new products and upgrades.

Companies are also looking for better ways to predict a patient’s risk of developing breast cancer and are streamlining the genetic testing process.

Here’s a look at what’s new from several companies.

Canon Medical
In April, Canon Medical released a new ultrasound system, the Aplio i-series Prism Edition. The system has a new beam-forming technology called iBeam+ that provides higher frame rates and increased signal to noise, and provides better penetration and detail at depth.

“This beam-forming technology is really a game changer,” said Dan Skyba, senior director of ultrasound business unit. “You're getting really phenomenal spatial resolution and less noise in the picture.”

The system also offers a higher frame rate for faster sweeps without loss of image quality, up to a 100% increase, according to Skyba.

“In today’s demanding environment, we've got to have quality exams but we need to have efficiency,” Skyba said. “The system absolutely keeps up with you.”

The new beam-forming technology is coupled with ultrahigh frequency transducers, including a 33 MHz transducer and a 24 MHz transducer that can now image at greater depths and see finer detail.

“In breast imaging, you want to use the highest frequency you can to get the best detail, but with the higher frequencies, you have less penetration, so they're only useful for very shallow depths,” said Karen Wager, senior manager of clinical development at Canon Medical. “But with a new beam-former, we've been able to really expand the utility of the 24 MHz transducer. I can scan down to 5 centimeters, so it's opened up the ability to scan much deeper in the body and much larger breasts. And now with the 33 MHz transducer, we’re also able to see beyond 3 centimeters, so it’s even more useful in a breast application. We weren't able to do that consistently before the Prism Edition.”

Canon also offers 17 MHz and 22 MHz high-frequency hockey stick transducers that can be used for examining lymph nodes or performing a biopsy.

The Aplio i-series Prism Edition comes with a technology called Full Focus which improves image uniformity and spatial resolution from near to far field and reduces the need for sonographers to manage ultrasound focal zones within the field of view . There are also features to optimize the workflow for breast ultrasound, such as a smart body mark, a breast scan guide and reference imaging. The system automates body markers based on the transducer position, and displays areas on a pictogram to show the sonographer where they’ve scanned. With reference imaging, prior ultrasounds or a mammogram, can also be displayed on the system.

“It's a way to boost your clinical confidence in the area you were just scanning to ensure that you're in the right place,” Wager said.

CureMetrix
CureMetrix recently conducted a retrospective research study for a new product under development, cmAngio, that uses a screening mammography exam to assess a patient’s age-based risk of heart disease. The product is AI-based detection software that helps doctors assess a patient’s risk of coronary heart disease (CHD).

The research study found that radiologists detected 72% of breast arterial calcifications, while cmAngio detected 95% with 98% specificity.

"To the extent that we can take (the mammogram) experience and leverage it into more clinical value for the patient and, for that matter, for the institution, then we're creating real value," said Kevin Harris, co-founder and president of CureMetrix. “There's no new radiation, no new effort by the patient, no new effort by the doctor. It's basically this automatic win.”

Looking at 150,000 mammograms across five institutions, CureMetrix found that although the breast arterial calcifications were present in about 17% of cases, they were only reported in 2%.

“It is an incidental finding and it's not being reported, and that's really the challenge,” Harris said. “The tool exists to be able to automate that process, to make this easy for the doctors so they don't have to do anything extra.”

cmAngio is in development and not yet available for commercial use in the U.S. or any other international markets.

Delphinus Medical Technologies
In October, Delphinus Medical Technologies received FDA premarket approval of its SoftVue 3D Whole Breast Ultrasound Tomography System for use as an adjunct screening tool to mammography for patients with dense breast tissue.

To use the system, the patient lies down on the table and each breast is suspended in water. The device has a ring transducer that uses what the company calls triple acoustic detection technology, capturing reflection, speed and attenuation, said Mark Forchette, the president and chief executive officer of Delphinus Medical Technologies.

“We have three pieces of data, and with that we can characterize masses in tissue at a much more definitive level than anything else,” Forchette said.

A recent clinical study of the system enrolled 8,500 patients and demonstrated a 10% improvement in accuracy, 20% improvement in sensitivity and 8% improvement in specificity.

“With that, we've demonstrated the ability to not only find additional cancers, but to potentially reduce callbacks and unnecessary biopsies,” Forchette said.

The study also found that 95% of patients would recommend the exam, which doesn’t require compression and takes about three minutes per breast.

Facilities can purchase the system outright, and the company also has an option that requires no money up front, with the facility paying per scan and using existing reading rooms and monitors.

“Maybe they didn't know last year that this was coming, and didn't budget for this, so now we've given them a really easy way to adopt it,” Forchette said. “We've made this as flexible as you can possibly make it because we don't want anything to stand in the way of this serving the unmet needs of women.”

GE Healthcare
St. Luke's University Health Network in Pennsylvania recently became the first U.S. facility to adopt GE Healthcare’s One-Stop Clinic rapid diagnostic breast cancer center model. There are also new sites in Colombia, Egypt and France.

GE's One-Stop Clinic breast care model originated at the Gustave Roussy Cancer Center in France. It’s designed to provide patients with a tightly coordinated journey from the initial appointment through diagnosis and treatment plan, in one location and with one team, in order to save time and speed up breast cancer diagnosis and treatment planning.

Since piloting the program in 2021, St. Luke’s has been able to reduce the time from screening to diagnosis and treatment to 36 hours or fewer for most patients, according to the company.

“We know that today, on average in the U.S., it takes women 21 days to get a result back from a biopsy,” said Celeste Slade, clinical solutions leader at GE Healthcare. “That is followed by weeks waiting to get a treatment plan. We can do better. And we know the science tells us that we can. For every 60 days that we delay treatment plans, cancer can advance for our patients, which limits our ability to give better clinical outcomes for those women. The One-Stop clinic model is all about redefining the patient's experience by reducing the time from screening to precise diagnosis and treatment plan, making a difference for the early detection of breast cancer and getting to answers and ‘what’s next’ faster.”

In Colombia, the One-Stop Clinic has reduced the time to treatment by roughly 93%.

In September 2021, GE Healthcare and Gustave Roussy also announced an initiative, backed by the Egyptian Ministry of Health and Population, that aims to accelerate early detection and treatment planning of breast cancer through the creation of rapid breast cancer diagnosis clinics in Egypt.

iCAD
In September 2021, iCAD launched two solutions as part of its Breast AI Suite. ProFound AI Risk for Digital Breast Tomosynthesis (DBT) is a new clinical decision support tool that provides a short-term breast cancer risk estimation that is personalized for each patient based on their mammogram. It combines a range of risk factors, including age, breast density and subtle mammographic features, offering approximately 2.4 times more accuracy than traditional long-term risk models, according to a recent study.

Physicians have traditionally estimated breast cancer risk by examining the patient’s known risk factors, such as family history; but about 85% of breast cancers occur in women who have no family history of breast cancer, said Stacey Stevens, president and chief executive officer of iCAD Inc.

In addition, some women have a higher risk of developing breast cancer based on their geographical location and ancestry. For example, African American women have an approximately 40% higher risk of dying from breast cancer compared to white women, and are disproportionately affected by more aggressive subtypes, such as triple-negative breast cancer and inflammatory breast cancer, Stevens said. ProFound AI Risk is specifically designed to factor in racial and ethnic backgrounds, as well as clinically-relevant global screening guidelines and more than 15 country incidence and mortality reference tables, for alignment with that country’s general population.

"Risk-based screening strategies for individual women can reduce harm and costs, but current risk models vary in accuracy and can be complex, cumbersome and costly to implement," Stevens said. "ProFound AI Risk is the first and only commercially-available clinical decision support tool that provides an accurate short-term breast cancer risk estimation that is truly personalized for each woman, based only on her mammogram. It offers the highest area under the curve (AUC) available for providing a one-year future risk estimation based on a screening mammogram. This advanced solution provides superior insights that empower clinicians to tailor a woman’s breast screening regimen and potentially identify cancers earlier, when they may be more easily treated."

Last year the company also launched the latest version of PowerLook Density Assessment, a multivendor, deep learning, automated breast density assessment algorithm that uses synthetic images generated from 3D mammography. It offers improved matching accuracy compared to previous versions of the software, Stevens said.

"These technologies offer the potential to truly transform personalized breast cancer screening and risk stratification, and could ultimately lead to more appropriate utilization of supplemental imaging and biopsies, less anxiety for women and decreased costs to the system overall," Stevens said.

Koning Corporation
Koning recently launched the third generation of its breast CT system, called Vera. The new version has a smaller footprint, improved resolution, lower radiation dose and a scan time reduced from 10 seconds to 7 seconds. As with all Breast CT devices, there is no breast compression.

Vera can also be outfitted to accommodate all breast imaging procedures, including 3D image-guided needle biopsy and contrast-enhanced imaging without gadolinium-based contrast agents, as an alternative to breast MR, said David Georges, president of Koning Corporation’s USA division.

“With contrast, it is a very suitable alternative to breast MR, which is obviously much more expensive, much more time consuming and they use a completely different contrast,” Georges said.

Unlike conventional mammography, the Koning Breast CT device supplies true isotropic 3D images, similar to whole body CT, including maximum intensity projection (MIP) and multiplanar reformation (MPR), Georges said. Radiation dose levels are in the same range as mammographic imaging, including for exams with contrast.

“Vera delivers a complete data set to the radiologist, providing opportunity to read a single image or view the area of interest in multiple planes,” Georges said. “[There’s] no need for additional views or retakes due to poor positioning, which is relatively common with mammography.”

PenRad
Earlier this year PenRad, which provides mammography tracking, reporting, analytics and compliance software, advanced its high-risk platform to include automatic identification of patients who are eligible for genetic testing, and bundled it with their automation solutions.

At the core of PenRad’s automation and patient intake solution is PenXpress. PenXpress facilitates the update of a patient's personal health history and risk, along with genetic testing eligibility documents, prior to the imaging appointment via a personal computer, tablet or mobile device. The solution, which is bundled with the company’s PenForms and PenConnect patient forms and electronic communication modules, streamlines patient intake and automates identification of patients at high risk of developing breast cancer and those eligible for genetic testing, creating opportunities for additional screening procedures such as breast MR and genetic screening for susceptibility to multiple cancer types.

“We focus on identifying patients that are eligible for advanced screening, facilitating workflow and driving revenue at busy women’s imaging clinics participating in high risk and genetic testing,” said Daniel Bickford, marketing director for PenRad. “PenGenetics, PenXpress, PenForms and PenConnect are all emblematic of that driving force at PenRad to save lives and optimize client revenue.”

Siemens Healthineers
Last fall, Siemens Healthineers received FDA clearance of its MAMMOVISTA B.smart reading platform and the teamplay Mammo Dashboard tool. The solutions speed up and optimize workflow.

The MAMMOVISTA B.smart reading platform is vendor-neutral and integrates other adjunctive imaging exams, including ultrasound and MR.

The platform is designed to decrease the time needed to load the current and prior examinations, by up to 75%, said Abby Weldon, senior director of women's health at Siemens Healthineers North America. AI-based tools, such as Transpara from ScreenPoint Medical, can be incorporated into the platform to highlight breast tissue abnormalities and provide an exam score indicating the probability of cancerous tissue.

The solution can help radiologists tackle a backlog of exams during the pandemic.

“Elective mammographic screenings were the first ones to get cut when it came to lockdown, but also some of the last ones for patients to revisit again, so any sort of solution that we provide on the vendor side to help backlog is going to be very beneficial,” Weldon said.

Also new is the Siemens Healthineers teamplay Mammo Dashboard, which helps providers monitor the key performance indicators of their mammography exams — including exam duration, compression force, radiation dose and device utilization — to help increase standardization.

“It’s extremely important to make sure that we are standardizing screenings, making sure that if a woman goes to one site and within a healthcare network, she should be getting the same exact quality of exam as if she were to go to another site,” Weldon said. “The goal is to help our customers, especially those that have a fleet of mammography systems, to improve their efficiency and also their quality of care.”

Volpara
Recently, the company updated its cancer risk assessment software platform, Volpara Risk Pathways, with new risk guidelines and has forged partnerships with genetic testing companies so that patient information flows seamlessly to them.

“For patients found to be at high risk, that information could flow automatically to the genetics companies to facilitate discussions for genetic testing,” said Ralph Highnam, chief scientist at Volpara. “Ten to 12% of all breast cancers are genetic, so that connection to the genetics world is very important.”

The company also launched a new version of its Volpara Analytics platform that helps sites monitor mammography quality with automated image quality metrics and educational tools to help ensure high-quality images are acquired. Analytics In Action is a new program offered in partnership with Mammography Educators, and provides mammography managers tools to recognize and reward individual performance, as well as opportunities for in-person education based on the educational needs identified.

“This program effectively enables them to hit a button and Mammography Educators will have access to the site analytics so they'll know exactly what the issue is, and they'll go to the site with very specific hands-on training to resolve the issue,” Highnam said.

The company also launched the Volpara Density Thumbnail, which inserts two nondiagnostic mammogram images from the patient’s exam, the percentage of breast density and a QR code link to a website for more information about breast density.