Turtle Health is seeking FDA clearance to bring at-home gynecological exams and fertility testing with transvaginal ultrasonography to market.

There’s no question that smartphones and tablets have given rise to a myriad of healthcare monitoring tools that are helping us stay healthier and more fit. But is it time for us to be able to use ultrasound to monitor what’s going on in our bodies?

If you ask Amy Zwanziger, Co-Founder and CEO of Turtle Health, the answer is a resounding “yes!” Zwanziger is on a mission to enable at-home gynecological ultrasound exams, including fertility testing, by enabling women to use transvaginal ultrasound.

 

Women have a fundamental right to information about their bodies, and we founded Turtle Health to empower women to access information when they need and want it, from the convenience and privacy of home,” says Amy Zwanziger, Co-Founder and CEO of Turtle Health. “We are delighted that new data support clear at-home visualization of the uterus and ovaries in a diverse range of women, which can be used for a variety of gynecological applications.”

A study funded by Turtle Health and published in the April 2022 edition of the Journal of Obstetrics and Gynecology shows that self-administered transvaginal ultrasound exams guided remotely by a trained technologist are comparable to in-clinic ultrasonography in producing clinical-quality images and assessing antral follicle count to estimate ovarian reserve, which is an important element in evaluating a women’s reproductive potential.

In a head-to-head crossover trial, participants performed self-administered virtual transvaginal ultrasonography at home guided by a remote-certified technologist, and then repeated the exam in-clinic,” says Turtle Health Co-Founder Josh Haselkorn. “The uterus and ovaries were visualized with ultrasound using the Clarius EC7 HD3 transvaginal scanner. Independent, blinded reproductive endocrinologists reviewed the ultrasound cine clips captured and confirmed that antral follicle counts were equivalent across settings. We’re thrilled that the study results show the efficacy of virtual transvaginal ultrasonography, and moreover, that participants reported greater satisfaction with their at-home experience.”

Turtle Health’s at-home testing solution uses the Clarius EC7 HD3 handheld wireless ultrasound scanner that works with the Clarius Ultrasound App on tablets. To perform the test, a trained technologist connects with the patient using Clarius Live telemedicine to provide real-time guidance for capturing clinical-quality images, which are subsequently sent for analysis.

Turtle Health is currently seeking regulatory authorization to use the Clarius scanner in this novel context. The study, and associated regulatory filing, are under review by the U.S. Food and Drug Administration (FDA).

We’re delighted to see the results of this research showing the efficacy of using Clarius ultrasound to empower virtual women’s health. Our easy-to-use wireless endocavity scanner, combined with the power of artificial intelligence, connection to the cloud, and one-touch telemedicine, offer a unique solution for patient engagement,” says Clarius President Ohad Arazi. “At Clarius, we’re working with partners to deliver highly specialized ultrasound imaging solutions to market. We’re pleased to work with Turtle Health to make gynecological care virtual and unlock access to affordable, patient-enabled ultrasound imaging.”

Tech Zone Podcast – AI Ultrasound in the Home?

Arazi and Zwanziger recently engaged in a provocative discussion about the merits of ultrasound use at home during a podcast on the Tech Zone by Paul Amadeus Lane of ABC News Radio.

Both CEOs were quick to respond to the question about how the pandemic helped push the boundaries of healthcare options.

Listen to « EP. 229-02-AI Ultrasound in the Home? » on Spreaker.

We knew before the pandemic that patients were ready,” said Amy Zwanziger of Turtle Health. “Our patients, they’re mostly younger women. Of course, they’re very forward-thinking – they’ve all been using technology, digital natives, their whole lives. I think the pandemic has really helped propel the medical profession to become a little bit more comfortable with change a little bit more quickly.”

Arazi expressed excitement about how changes in healthcare have been accelerated.

I think COVID really opened everyone’s eyes to say we can deliver high-quality care even without bringing patients to these urgent care centers or to hospitals,” he said. “And I think we’ll see much more of that when care is coming to the home. And ultimately, it’s going in the hands of patients.”

Listen to the full discussion on Apple Podcasts.

Clarius for Healthcare Professionals

Clarius handheld scanners are designed for medical professionals in every medical specialty. Our line of 10 wireless scanners connect to iOS and Android devices and deliver high-resolution ultrasound imaging for a fraction of the cost of traditional ultrasound systems. Artificial intelligence replaces complex knobs and buttons, making the Clarius imaging experience intuitive, even for novice users.

To learn about which handheld ultrasound is right for your medical practice, contact us or schedule a private virtual demonstration.