Ukraine clears breakthrough SaaMD that enables people to usetheir smartphones as clinical-grade devices that listen for cardiovascular disease at home.
Sparrow BioAcoustics announced it has received clearance from the State Service of Ukraine for Medicines and Drugs Control for its Stethophone™ app to be used by patients and their families, as well as by medical professioinals.
“Sparrow BioAcoustics is proud to receive its first full approval for patients to use Stethophone in Ukraine,” said Mark Opauszky, CEO of Sparrow. “Like many people, members of our team are close to Ukraine and neighboring countries in Eastern Europe. We wanted to be able to help patients in this nation. Like the U.S. Food and Drug Administration, the Ukrainian health authority is known for its high standards and strong focus on public safety.”
Earlier this year, the FDA granted clearance for Stethophone to be used by medical professionals and emergency medical technicians to monitor, record and share the sounds of the heart and lungs. In Sparrow’s clinical tests, Stethophone outperforms the class-leading traditional stethoscopes in cardiac and pulmonary auscultation.
Stethophone is a breakthrough Software as a Medical Device (SaaMD) app that enables smartphones to capture, isolate and evaluate the sounds of the heart and lungs simply by placing the microphone of a smartphone against a patient’s chest. The information is processed for both visual and auditory evaluation, and can be securely shared with other members of the care team. This makes Stethophone the clinical-grade stethoscope that is always with you, and can capture the sounds of symptoms whenever and wherever they occur.
The downloadable Stethophone™ application uses advanced acoustic processing to provide smartphones with highly sensitive cardiac and pulmonary listening capability. Stethophone is unique in that there is nothing new to plug in, charge, or connect. Heart and lung sounds are captured by simply holding a smartphone to a patient’s chest.
“There is a world of diagnostic information contained in chest sounds, and the healthcare system needs a practical way to capture this data and put it to work for the benefit of patients,” said Opauszky. “Stethophone is the tool to do this.”
In trials conducted at Eastern Health Medical Centre, Newfoundland, Canada, 70 percent of medical professionals rated Stethophone superior in diagnostic sound performance over other leading devices. Stethophone also performed significantly higher in overall correct heart pathology diagnosis and correct normal heart diagnosis.
Cardiovascular diseases (CVDs) are the leading cause of death globally, representing 32 percent of all global deaths. The number of people at risk of CVD is on the rise. The American heart association reports that nearly half of all U.S. adults have some type of cardiovascular disease.
