Category: Ultrasound

Studies Support Breast Ultrasound for Screening

Posted on by Brian Casey

A pair of new research studies offers guidance on when and where to use ultrasound for breast screening. The publications highlight the important advances being made in one of radiology’s most versatile modalities. 

Ultrasound is used in developed countries for supplementary breast cancer screening in women who may not be suitable for X-ray-based mammography due to issues like dense breast tissue.

  • Ultrasound is also being examined as a primary screening tool in developing regions like China and Africa, where access to mammography may be limited.

But despite growing use, there are still many questions about exactly when and where ultrasound is best employed in a breast screening role – and this week’s studies shed some light. 

First up is a study in Academic Radiology in which researchers compared second-look ultrasound to mammography in women with suspicious lesions found on breast MRI. 

  • Their goal was to find the best clinical path for working up MRI-detected lesions without performing too many unnecessary biopsies. 

In a group of 221 women, second-look ultrasound was largely superior to mammography with… 

  • Higher detection rates for mass lesions (56% vs. 17%).
  • A much higher detection rate for malignant mass lesions > 10 mm (89%).
  • But worse performance with malignant non-mass lesions (22% vs. 38%).

They concluded second-look ultrasound is a great tool for assessment and biopsy of MRI-detected lesions > 10 mm without calcifications. 

  • It’s not so great for suspicious non-mass lesions, which might be better sent to mammography for further workup. 

Breast ultrasound of non-mass lesions was also the focus of a second study, this one published in Radiology. 

  • Non-mass lesions are becoming more frequent as more women with dense breast tissue get supplemental screening, but incidence and malignancy rates are low. 

So how should they be managed? In a study of 993 women with non-mass lesions found on whole-breast handheld screening ultrasound, researchers classified by odds ratios the factors indicating malignancy…

  • Associated calcifications (OR=21.6).
  • Posterior shadowing (OR=6.9).
  • Segmental distribution (OR=6.2).
  • Mixed echogenicity (OR=5.0).
  • Larger size (2.6 vs. 1.9 mm).
  • Negative mammography (2.8% vs. 29%).

The Takeaway

Ultrasound’s value comes from its high prevalence, low cost, and ease of use, but in many ways clinicians are still exploring its optimal role in breast cancer screening. This week’s research studies should help.

ABUS Flies Solo for Breast Screening

Posted on by Brian Casey

Is breast ultrasound ready for use as a primary breast screening modality – without mammography? Maybe not in developed countries, but researchers in China gave automated breast ultrasound a try, with results that are worth checking out in a new study in AJR. 

Mammography is unquestionably the primary imaging modality for first-line breast screening, with other technologies like ultrasound and MRI taking a supplemental role, such as for working up questionable cases or for women with dense breast tissue.

  • But the standard mammography-dominated paradigm might not be suitable for some resource-challenged countries that have yet to build an installed base of X-ray-based mammography systems. 

One of these countries is China, which not only has fewer mammography systems in rural areas but also has a population of women who have denser breast tissue, which can cause problems with conventional mammography. 

  • As a result, the Chinese National Breast Cancer Screening Program has adopted ultrasound as its primary screening modality, with women ages 35-69 eligible for screening breast ultrasound every 2-3 years. Mammography is reserved for additional workup. 

But handheld ultrasound has challenges of its own. It’s operator-dependent, and image interpretation requires experienced radiologists – also in short supply in some Chinese regions.

  • So the AJR researchers performed a study of 6k women who were screened with GE HealthCare’s Invenia ABUS 2.0 scanner, which uses ultrasound to scan women lying in the supine position. Images were sent via teleradiology to expert radiologists at a remote institution.

How did ABUS perform as a primary screening modality? The researchers found that after a single round of screening …

  • ABUS had a cancer detection rate of 4.0 cancers per 1k women (4.4 for women 40-69).
  • Sensitivity was 92% and specificity was 88%.
  • Abnormal interpretation rate was 12%.
  • 96% of detected cancers were invasive, and 74% were node-negative.
  • Two interval cancers were detected (rate of 0.33 per 1k).

How do the numbers compare to mammography? 

  • The cancer detection rate in the Breast Cancer Surveillance Consortium study was 5.1 cancers per 1k women, so not far off. 

The Takeaway

The results offer an interesting look at an alternative to the mammography-first breast screening paradigm used in developed countries, where ABUS is mostly used as a supplemental technology. For resource-challenged areas around the world, ABUS with teleradiology could solve multiple problems at once.

US Tomo for Dense Breasts

Posted on by Brian Casey

What’s the best way to provide supplemental imaging when screening women with dense breasts? A new study this week in Radiology offers support for a newer method, whole-breast ultrasound tomography. 

It’s well-known by now that dense breast tissue presents challenges to traditional X-ray-based mammography.

  • In fact, mammography screening’s mortality reduction is far lower in women with dense breasts compared to nondense breasts (13% vs. 41%). 

A variety of alternative technologies have been developed to provide supplemental imaging for women with dense breasts, from handheld ultrasound to breast MRI to molecular breast imaging. 

  • One supplemental technology is whole-breast tomography, developed by Delphinus Medical Technologies; the firm’s SoftVue 3D system was approved by the FDA in 2021 as an adjunct to full-field digital mammography for screening women with dense breast tissue. 

With SoftVue, women lie prone on a table with the breast stabilized in a water-filled chamber that provides coupling of sound energy between the breast and a ring transducer that scans the entire breast in 2-4 minutes.

  • Unlike handheld ultrasound, the scanner provides volumetric coronal images that provide a better view of the fat-glandular interface, where many cancers are located.

SoftVue’s performance was analyzed by researchers from USC and the University of Chicago in a retrospective study funded by Delphinus. 

  • They performed SoftVue scans along with digital mammography on 140 women with dense breast tissue from 2017 to 2019; 36 of the women were eventually diagnosed with cancer. 

In all, 32 readers interpreted the scans, comparing the performance of FFDM with ultrasound tomography to FFDM alone, finding … 

  • Better performance with FFDM + ultrasound tomography (AUC=0.60 vs. 0.54)
  • An increase in sensitivity in women with mammograms graded as BI-RADS 4 (suspicious), (37% vs. 30%) 
  • No statistically significant difference in sensitivity in BI-RADS 3 cases (probably benign), (40% vs. 33%, p=0.08)
  • A mean of 3.3 more true-positive and 0.9 false-negative findings per reader with ultrasound tomography, a net gain of 2.4

The Takeaway

The findings indicate that ultrasound tomography could become a new supplementary tool for imaging women with dense breasts. They are also a shot in the arm for Delphinus, which as a smaller vendor has the challenge of competing with large multinational OEMs that also offer technologies for supplemental breast screening. 

POCUS Cuts DVT Stays

Posted on by Brian Casey

Using POCUS in the emergency department (ED) to scan patients with suspected deep vein thrombosis (DVT) cut their length of stay in the ED in half. 

Reducing hospital length of stay is one of the holy grails of healthcare quality improvement. 

  • It’s not only more expensive to keep patients in the hospital longer, but it can expose them to morbidities like hospital-acquired infections.

Patients admitted with suspected DVT often receive ultrasound scans performed by radiologists or sonographers to determine whether the blood clot is at risk of breaking off – a possibly fatal result. 

  • But this requires a referral to the radiology department. What if emergency physicians performed the scans themselves with POCUS?

To answer this question, researchers at this week’s European Emergency Medicine Conference presented results from a study of 93 patients at two hospitals in Finland.

  • From October 2017 to October 2019, patients presenting at the ED received POCUS scans from emergency doctors trained on the devices. 

Results were compared to 135 control patients who got usual care and were sent directly to radiology departments for ultrasound. 

  • Researchers found that POCUS reduced ED length of stay from 4.5 hours to 2.3 hours, a drop of 52%.

Researchers described the findings as “convincing,” especially as they occurred at two different facilities. The results also answer a recent study that found POCUS only affected length of stay when performed on the night shift. 

The Takeaway
Radiology might not be so happy to see patient referrals diverted from their department, but the results are yet another feather in the cap for POCUS, which continues to show that – when in the right hands – it can have a big impact on healthcare quality.

Ultrasound Spots Breech Pregnancies

Posted on by Brian Casey

Performing routine third-trimester ultrasound scans on pregnant women could help identify breech pregnancies, giving women the opportunity to consider alternative birth options. UK researchers in PLOS Medicine said the impact was found with both conventional and POCUS ultrasound scanners. 

While the incidence of breech presentation at full term is only 3-4%, when breech births do occur they can result in higher morbidity and mortality for both babies and mothers. 

In the UK, third-trimester ultrasound scans aren’t routinely performed for low-risk women, missing a chance to give them other options like Cesarean birth.

  • Therefore, researchers investigated the effectiveness and impact of these scans at two hospitals, one that used conventional ultrasound scanners and the other employing POCUS units (GE HealthCare’s Vscan Air).
  • At the POCUS facility, scans were typically performed by trained midwives. Women were scanned between 2016 to 2021 at both hospitals.

Performing routine ultrasound scans at 36 weeks reduced the incidence of undiagnosed breech presentation by 71% at the hospital using conventional ultrasound and 69% at the POCUS hospital.

  • The rate of undiagnosed breech presentation dropped from 14.2% to 2.8% with conventional ultrasound and from 16.2% to 3.5% with POCUS.
  • The scans also had an impact on babies’ health. Infants born at either facility had less likelihood of a lower Apgar score (<7) five minutes after birth, and babies were less likely to be sent to the neonatal care unit.

The researchers believe their findings suggest a revision of the UK’s clinical guidelines, which don’t currently call for routine third-trimester ultrasound scans for low-risk women. With respect to POCUS, they said their research was the first to investigate the technology for diagnosing fetal presentation, and their findings support wider use of POCUS in areas where conventional ultrasound isn’t available. 

The Takeaway

What’s really exciting about this study are the findings about POCUS. Maternal-fetal complications are a huge problem in developing countries and places with less access to imaging technology. POCUS scanners could be used by trained personnel like midwives – perhaps with AI assistance –  to identify problems before birth.

GE HealthCare Adds Ultrasound Guidance with Caption Health Acquisition

Posted on by Jake Fishman

GE HealthCare took a major step towards expanding its ultrasound systems to new users and settings, acquiring AI guidance startup Caption Health.

GE plans to integrate Caption’s AI guidance technology into its ultrasound platform, starting with POCUS devices and echocardiography exams. GE specifically emphasized how its Caption integration will help streamline echo adoption among novice operators and bring heart failure exams into “doctors’ offices, the home, and alternate sites of care.”

  • That’s particularly notable given healthcare’s major shift outside of hospital walls, especially considering that Caption has already developed a unique home echo exam and virtual diagnosis service. 
  • It’s also another sign that GE sees big potential for at-home ultrasound, coming less than a year after investing in home maternity ultrasound startup Pulsenmore.

GE didn’t disclose the tuck-in acquisition’s value. However, Caption is relatively large for an AI startup (79 employees on LinkedIn, >$62M raised) and is arguably the most established company in the ultrasound guidance segment (FDA & CE approved, CMS-reimbursed, notable alliances).

  • The fact that GE HealthCare has already made two acquisitions since spinning off in early January (after a 16 month pause) also suggests that the newly-independent medtech giant has returned to M&A mode.

Of course, the acquisition is another sign that the imaging AI consolidation trend remains in full swing, marking at least the ninth AI startup acquisition since January 2022 and the third so far in 2023.

  • One contributor to that AI consolidation surge appears to be ultrasound hardware vendors acquiring AI guidance companies, noting that GE’s Caption acquisition comes about six months after Exo’s acquisition of Medo AI.

The Takeaway

Ultrasound’s potential expansion to new users and clinical settings could create the kind of growth that most modalities only experience once in their lifetime (or never experience), and ease of use might dictate how far ultrasound is able to expand. That could make this acquisition particularly significant for GE HealthCare and for ultrasound’s path towards far broader adoption.

Home Ultrasound Goes Mainstream

Posted on by Jake Fishman

Patients performing their own at-home ultrasound exams sounds like a pretty futuristic idea, but it’s becoming increasingly common in Israel due to a growing partnership between Clalit Health Services (Israel’s largest HMO) and DIY ultrasound startup Pulsenmore.

DIY Fertility Ultrasound – Clalit and Pulsenmore just signed an $11M agreement that will equip Clalit’s fertility treatment patients with thousands of Pulsenmore FC ultrasound systems over the next four years. The patients will use the Pulsenmore FC to perform self-exams during the IVF (in vitro fertilization) and fertility preservation processes and then transmit their scans to Clalit’s fertility clinicians. 

Pulsenmore Momentum – Pulsenmore previously provided Clalit with thousands of Pulsenmore ES fetal ultrasound systems, allowing expecting mothers to perform and transmit nearly 15k fetal ultrasounds since mid-2020. Pulsenmore also landed an interesting deal with Tel Aviv’s Sheba Medical Center in early 2021 that allowed pregnant women in Sheba’s COVID ward to perform their own fetal ultrasounds and transmit the scans to the hospital’s maternity ward.

Pulsenmore Potential – Pulsenmore’s early momentum is certainly helped by Israel’s unique healthcare system, but the company also has a European CE Mark (for the ES system), $40M in IPO funding, and ambitions to expand globally.

The Takeaway

The fact that thousands of ultrasounds are being used in Israeli homes shows that the home ultrasound concept has mainstream potential, and there’s a growing list of factors that could make it a reality. We’ve already seen a similar home system from Butterfly Network and a major industry trend towards smaller and easier to use ultrasounds (or even wearable), while the COVID pandemic has increasingly normalized at-home diagnostics and teleconsultations.

It will take some big changes for handheld ultrasounds to become MORE common than the stethoscope, but that idea doesn’t seem as ridiculous as it did a few years ago.

GE Acquires BK Medical

Posted on by Jake Fishman

GE Healthcare’s ultrasound portfolio became a lot more diverse last week with its acquisition of surgical ultrasound company BK Medical. Here’s some details and perspectives:

The Acquisition – GE Healthcare will acquire BK Medical from Altaris Capital Partners for $1.45b, separating BK Medical from Analogic. That’s a pretty big investment considering that GE’s ultrasound unit brings in $3b a year.

GE’s Surgical Expansion – With BK Medical, GE’s ultrasound unit expands from diagnostics to intraoperative imaging and surgical navigation, which is reportedly a fast-growing and high-margin business for BK Medical. 

The BK Portfolio – BK Medical got its start in urology ultrasound, and more recently expanded to ultrasound systems used to guide minimally invasive and robotic surgeries and to visualize deep tissue during neuro and abdominal surgeries. That adds up to five unique ultrasound systems.

GE Impact – GE sees a lot of value in BK Medical. BK gives GE an ultrasound portfolio that the other OEMs can’t match (diagnostic, surgical, post-operative), “accelerates” GE’s precision health strategy, and will reportedly deliver “high-single-digit” ROI within five years.

GE Acquisition Trend – While GE Healthcare spent 2018 and 2019 selling major non-imaging businesses (value-based care to Veritas Capital, life sciences to Danaher), GE’s 2020 and 2021 acquisitions have focused on expanding its capabilities within imaging (Zionexa for radiopharmaceuticals, Prismatic Sensors for CT detectors, and now BK Medical for ultrasound). That says a lot about GE Healthcare’s imaging focus, and is quite different from Philips and Siemens, which have increasingly targeted M&A outside of imaging.

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