'In MedTech History' - Ultrasound, Part 2: Two Notable Technology Firsts

ARTICLE SUMMARY:

In this week’s post, we continue our look at one of the world’s most versatile and essential medical technologies: ultrasound. Two recent leaps forward in this space are helping to expand ultrasound’s reach beyond anything its early pioneers could have imagined.

Butterfly Network: Personal Ultrasound

Butterfly Network Inc., founded in 2011 by Jonathan Rothberg, PhD, best known for inventing next-generation DNA sequencing, has developed a first-of-its-kind, $2,000 pocket-sized “ultrasound on chip” device that plugs into an iPhone. The company’s mission is to democratize healthcare by making medical imaging accessible to every physician and healthcare worker around the world.

Ultrasound systems, which in general are cumbersome, cart-mounted devices costing $30,000-$200,000, traditionally use piezoelectric crystals to generate sound waves that then create images of tissues within the body. Butterfly replaced those crystals with a silicon chip, which allows a single sensor to do the work of multiple ultrasound attachments, in a hand-held, bedside-use device. It combined this design with artificial intelligence (AI) technology, with the goal of making whole-body imaging technology accessible to all—including two-thirds of the world currently with no access to medical imaging. Images are collected via the Butterfly iQ app and then sent directly to a HIPAA-compliant cloud. Butterfly iQ received FDA clearance in 2017 for 13 indications including fetal, abdominal, cardiac, gynecological, urological, and pediatric cases, and began shipping to US customers last year.

The Community Blog spoke with John Martin, MD, vascular surgeon and Butterfly’s chief medical officer. Martin happened to detect his own throat cancer while testing the Butterfly iQ device after he joined the company. He emphasizes the potential impact of Butterfly iQ in challenging environments such as in the developing world. “One of the leading causes of mortality in infants and small children is pediatric pneumonia, and they struggle in the developing world with making this diagnosis with no imaging tools. We’ve put Butterfly iQ in the hands of these physicians and it’s had a dramatic impact on their use of antibiotics only in those children who need it,” he says.

The company is developing an augmented reality telemedicine technology to be used with its Butterfly iQ device, called Butterfly Tele-Guidance technology. In the future, this technology will allow an ultrasound expert to remotely guide any user to acquire even the most challenging ultrasound. Last September, the well-financed company raised a $250 million Series D led by Fidelity with participation from Fosun Pharma, the Gates Foundation and Jamie Dinan, along with returning existing investors.

A First-of-its-Kind View of the Fetal Heart

Evaluating the fetal heart is a challenge. A developing baby is in constant motion, and at 18 weeks, its heart is the size of an olive and beating about 150 times per minute. In fact, it can be one of the most difficult ultrasound exams to perform. Now, clinicians have the ability to view the fetal heart’s shape, size and how it is contracting, thanks to ultrasound and advanced alteredsoftware. At the 2018 Radiological Society of North America (RSNA) conference, GE Healthcare introduced its new fetalHQ heart and vascular software for use on its Voluson E10 ultrasound system—the first tool to simultaneously examine the size, shape, and function of the fetal heart, in under three minutes. “This may provide new insights for babies suffering from Intrauterine Growth Restriction, Fetal Anemia and Twin to Twin Transfusion syndrome, among others,” says Barbara Del Prince, Director of Global Product and Clinical Management at GE Healthcare Women’s Health Ultrasound, in an interview with the Community Blog.

Del Prince, who started her career as a sonographer with a special interest in obstetrics and gynecology, described her experience with a case in which a woman came in with a fetus in tachycardia; the fetus was very ill with fluid around the heart and in the abdomen. “We treated the fetus in utero and after 24 hours we could see a complete reversal—the extra fluid was now gone and the heart was beating normally,” she says. “This was amazing to me and showed me the power that ultrasound technology had to enhance the lives of women and their unborn children. The simplicity of fetalHQ struck me in a similar way, it allows clinicians to gain critical insights into fetal health which may dramatically impact outcome.”

See the MedTech Strategist archives for additional coverage of this rapidly evolving space.

 

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