Just three years after it was founded in 2015, Israeli startup PulseNmore announced that it was in the final stages of developing a revolutionary, handheld telemedicine device that would allow pregnant women to perform an ultrasound scan on their fetuses using only their smartphones. Little did the company know that just a couple years later, the world would be in midst of a devastating global health crisis that would see many avoid hospitals and clinics for fear of contracting the novel coronavirus.
Since March, medical facilities have been quick to convince people that nonessential medical, surgical, and dental procedures should be avoided until the COVID-19 pandemic is fully contained or when there is a vaccine against the disease. This makes a portable device like PulseNmore, officially launched this month, an essential way for pregnant women to get the frequent checkups they need while allowing them to stay home for up to half of their prenatal visits.
The launch of the device came at an opportune time, Jordan Rubinson, chief commercial officer of PulseNmore, told NoCamels. “The coronavirus pandemic has brought to light the need for telemedicine devices and telemedicine options, which are now replacing face-to-face doctor visits more broadly.”
Israel’s largest healthcare provider, Clalit Health Services, is the first health maintenance organization (HMO) to make the device available. The provider, which has 4.6 million members, has signed a multi-year agreement with the Israeli startup to provide its pregnant members with PulseNmore’s product.
“Being that we are the first in Israel to launch an online service for doctor appointments and online medical examinations, purchasing the PulseNmore device was a natural choice for us,” a representative from Clalit said. “Our customers can now receive top medical services during the period of their pregnancy, without having to leave the comfort of their home.”
“According to Clalit, pregnant women pay ‘false’ visits to the emergency room more than twice on average with concerns about their baby’s well-being,” said Elazar Sonnenschein, founder and CEO of PulseNmore, in the company’s announcement. “Our solution provides vital information to healthcare providers to determine if a baby is healthy, helping expectant mothers have peace of mind at home and avoid unnecessary visits to the ER.”
The device is intended to determine the vitality of the fetus and “is not intended to replace scans for detection of fetal defects which are typically performed at clinics or hospitals,” said Rubinson. He noted that the device can be used in online mode via videoconferencing applications to replace a scheduled pregnancy ultrasound scan.
Arnon Wiznitzer, chairman of the Department of Obstetrics and Gynecology at Rabin Medical Center, will oversee the new service at Clalit.
“Amid the COVID-19 challenges, clinicians are proposing alternative designs for prenatal care that mobilize telemedicine to allow for virtual visits as opposed to only in-person consultations,” he said. “Mobile medical devices enable digital information-sharing with healthcare professionals for clinical consultation, follow-up, and documentation. Using these devices offers advantages in patient care and involvement, with possible benefits for clinical outcomes and cost-effectiveness.”
PulseNmore already has CE approval in Europe, approval in Israel, and is seeking FDA clearance in the US.
The company’s plan is to sell the product at affordable prices to HMOs, large health insurance companies, and leading hospitals that offer virtual visit services to replace physical visits at the hospital, according to Rubinson.
Discussions with leading health service organizations and distribution partners in Europe are ongoing, the company indicated.
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Pregnancy scans with a smartphone
The self-administered PulseNmore device docks with a smartphone and leverages advanced navigation and AI technology, as well as an app, to guide users through the scanning process. It displays and shares high-quality images with the user’s personal care provider.
PulseNmore’s tech involves both hardware and software, Rubinson told NoCamels. “We have offloaded the power, screen, communication, and control of the device to the cell phone and focused on simplifying the transducer to do its main job well. This has allowed us to bring the price of the device down from the thousands to the hundreds, driving affordability and accessibility,” he says.
In addition, the company created software innovations with the introduction of the PulseNmore app, which makes performing an ultrasound scan very simple.
Rubinson said the device connects its user to medical professionals through both online and offline modes. In online mode, the device activates a videoconferencing telehealth session between a physician and a pregnant person, and the scan is performed live and interactively. In offline mode, the pregnant person is given a code to use the device in between visits if she has a concern. The scans are all uploaded and sent to the physician.
The device is semi-disposable and can be used up to 50 times over a given pregnancy, but it cannot be serviced, redeployed, or used over an extended period of time.
Clalit called PulseNmore a “device that will change the world,” and said it expects to offer it to members in the coming months. Patients will be able to use the device from week 14 of their pregnancy, according to Clalit.
Rubinson told NoCamels that physicians from the HMO performed a clinical study where they reviewed more than 1,300 self-scans with the PulseNmore device. In 95% of the ultrasound videos, the heartbeat, movement, and amniotic fluid, among other measures, were detected in a three-minute process.
Clalit says it will also be opening a women’s health center hotline, running between 8:00 a.m. and 10:00 p.m. every day for women who are concerned about the health of their fetus, and to have their scans reviewed by sonographers and obstetricians, Rubinson told NoCamels. The hotline will be managed by experts from the Rabin Medical Center, also known as Beilinson Hospital, in Petah Tikva.
“We are proud to lead another breakthrough in telemedicine and to offer our members a remote and convenient ultrasound service that meets the needs of the coronavirus period and beyond,” said Ehud Davidson, director-general of Clalit. “The uniqueness of our offering lies in our service concept that combines subsidizing the cost of PulseNmore’s device and offering services for medical guidance and advice provided by Clalit’s best experts.”
Sonnenschein calls the at-home tele-ultrasound scanning device a “major leap forward in digital medicine and prenatal health.”
“We have successfully miniaturized the traditional ultrasound system to create a solution that is both affordable and accessible for expectant families,” he said.
PulseNmore is based in Omer, Israel, and currently employs 40 people. It is backed by private shareholders and has received support from the Israeli Innovation Authority.