FDA-cleared AI-powered lung sound detection tool brings specialist to primary care, home

ByIsabella Hornick

Fact checked byKristen Dowd

Key takeaways:

Wheeze, crackles and rhonchi can be detected by an AI algorithm in the TytoCare device.
The TytoCare device is designed for use in primary care clinics and patient homes.

The FDA has granted clearance to TytoCare’s AI-powered Tyto Insights for Lung Sounds to detect rhonchi, marking the third lung sound alongside wheeze and crackles to receive the designation, according to a press release.

“We now have a full suite for the lungs, including detection of wheeze, crackles and rhonchi, which are the most frequent sound abnormalities in the lung area,” Elad Lachmanovich, BSc, MSc, chief product and technology officer at TytoCare, told Healio.

Designed for use in both primary care clinics and patient homes, Lachmanovich said the AI algorithm behind Tyto Insights for Lung Sounds presents the physician and patient with a specialist’s/pulmonologist’s second opinion and allows for earlier diagnosis and treatment.

The AI algorithm is within Tyto’s digital stethoscope device and is activated during a lung exam, according to the release and webpage on Tyto Insights for Wheeze Detection.

Patients and clinicians can use TytoCare’s Tyto Insights for Lung Sounds to help them identify when they are experiencing wheeze, crackles or rhonchi.

Source: TytoCare

“We built our algorithm using a board of pulmonologists, and those algorithms bring sound detection and segregation between the different lung abnormalities to the primary care physician and even to the patient at home,” Lachmanovich told Healio.

“The need to segregate between those sounds is critical in order to diagnose the patient well,” he added.

The release highlighted that TytoCare’s database contains 1.8 million lung sound recordings captured via real-world use of the Tyto Stethoscope. Following pulmonologists’ identification of abnormalities in the sounds, these recordings helped train the AI algorithm.

“In these data, we have different geographies, different patient ages and different conditions, and we use all of that data in order to build a very good algorithm that can help with analysis and identify the right sound,” Lachmanovich told Healio.

According to the release, during testing of the AI algorithm’s performance using area under the receiver operating characteristic curve (AUC), researchers observed better discriminative ability across wheeze, crackle and rhonchi sounds with the AI algorithm (AUC, 95.85%) vs. pulmonologists (83.03%) and general practitioners (79.45%).

“When we bring the level of a specialist to primary care physicians/nurses, it gives treatment or diagnosis earlier in the process and higher quality care from the physicians and nurses,” Lachmanovich said. “We can verify that the right treatment will be given on time to the patient.”

While Tyto Insights for Lung Sounds identifies sounds important in the diagnoses of asthma, COPD, bronchitis and pneumonia, Lachmanovich emphasized that other patient factors should be considered before a diagnosis can be made.

“The history and other measurements also matter,” Lachmanovich said.

Taking other factors into consideration is also outlined on the webpage for Tyto Insights for Wheeze Detection.

According to this webpage, “if wheezing is detected, the clinician will receive an indication on their Clinical Station. In conjunction with other relevant exams and patient data, the clinician decides on a diagnosis and writes a prescription for treatment if needed.”

In addition to lung sound detection, Lachmanovich highlighted that TytoCare’s platform features a self-management module for patients using the device at home.

“This empowers the patient mainly to understand and learn about the condition,” Lachmanovich told Healio. “In an example of a parent with a child with asthma, you always need to consult with the physician, but it’s helping them be less afraid and more knowledgeable about their kid’s condition.”

With current physician shortage issues, Lachmanovich said the remote/home element of TytoCare’s platform is especially notable.

“If you can move and transfer more of the diagnosis and treatment processes to the home setup, availability is usually much higher,” Lachmanovich told Healio.