Shining a Light on UltraSight’s Recent Successes  

by | Apr 5, 2024 | Companies, Fogarty Innovation

UltraSight has come a long way since graduating from Fogarty Innovation’s Company Accelerator Program (CAP) in 2022. The company’s groundbreaking AI-driven real time guidance software increases access to point-of-care cardiac ultrasound, revolutionizing cardiac care by empowering healthcare professionals, regardless of sonography proficiency, to successfully perform high-quality ultrasound imaging. 

With an initial focus on the urgent care setting, the technology allows hospital staff to advance patient triage and treatment with increased efficiency and clinical confidence. It also promises to increase access to care for chronic heart disease patients because it will bring cardiac ultrasound closer to patients in local communities.

UltraSight is thriving after a number of significant successes. 

Securing key approvals and patents 

Last year, the company received FDA 510(k) clearance, which allows the company to bring its innovation to market with an initial soft launch at leading hospitals in the U.S. The clearance complements previous receipt of a CE Mark in the EU and UKCA Marking in the UK. 

UltraSight was also granted a patent for real-time guidance software, issued in the U.S. and Europe—the first company in the world to receive a patent for this kind of technology. “This was an incredibly important accomplishment as it’s very hard to protect AI with patents,” said Davidi Vortman, UltraSight CEO. “We see this is a significant milestone in proving that deep learning technology can be protected.” 

UltraSight also published its landmark pivotal study results in Circulation Cardiovascular Imaging and won the Bristol Myers Squibb Improving Cardiovascular Disease Outcomes Challenge as the most innovative cardiac technology at the HLTH conference, which is focused on health innovation and transformation.

Successful launch garners interest and excitement

UltraSight’s soft launch in the U.S. is generating excellent feedback, with emergency and ICU personnel excited about the prospect of no longer having to summon sonographers in the middle of the night. 

In Europe, a study in conjunction with Hôpital Européen Georges-Pompidou will start soon. The multi-center study will be conducted at several sites throughout France with the goal of demonstrating that the product can be effectively used by medical students. This utility is crucial in isolated rural areas where it is challenging to locate sonographers or cardiologists. 

Partnering with industry leaders

Partnerships are another key part of launch efforts. UltraSight has teamed up with EchoNous, a point-of-care ultrasound device manufacturer based in the U.S. to bring the benefits of  cardiac imaging to new healthcare settings. 

The second partnership is with SELVAS Healthcare, a publicly traded Korean healthcare company which serves approximately 30,000 “checkup clinic” locations across the country. Every Korean citizen undergoes a mandatory annual checkup, which includes a cardiac ultrasound. The goal of this collaboration is to make cardiac ultrasound exams available at these clinics as well as in hospitals, following regulatory approval. UltraSight is currently working to gain regulatory approval in Korea. 

New developments on the horizon

While UltraSight’s software is currently used with a Phillips Lumify point-of-care ultrasound device, the company is working to expand availability on additional devices. 

As an Israeli company, UltraSight has been gratified to support medics in combat situations. Following the attack on October 7, the company immediately offered its technology to Israeli Medical corps to help triage care in the field. In partnership with Haifa University, UltraSight donated 20 ultrasound military-grade devices to diverse units, including the Navy Seals, medics, paratroopers and more. 

“We are very proud to have the opportunity to serve medics in the field, to help them make quick decisions and potentially save lives with minimal training,” Vortman said. 

Enduring ties to Fogarty

UltraSight remains deeply connected to the “Fogarty family,” as it continues to work closely with the organization. This partnership includes guidance from Marga Ortigas-Wedekind serving as a commercial advisor helping with market access, and Zach Edmonds, MD, as a medical advisor. “We are very proud to be a Fogarty alumnus,” said Vortman. “The Fogarty team has been tremendously supportive and helpful in our quest to commercialize. We’ve stayed very close to the leadership team and rely on them as an ongoing resource who share their expertise on everything from testing to successful market launches. Their continued support has been invaluable.”

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