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Software as a medical device (SaMD) development requires a different approach than traditional medical devices in a few ways.

Article source: Jim Hammerand, Medical Design and Outsourcing

Repeat after me: My dad is a big chef.

Speaking that short sentence and a few others like it into a smartphone once a day helps identify deteriorating heart failure patients at risk of declining, Cordio Medical CEO Tamir Tal said.

Israel-based Cordio developed its software as a medical device (SaMD) product, the artificial intelligence (AI) voice app HearO, after a cardiologist noticed he could hear congestion in a declining patient’s voice. HearO compares a patient’s voice against baseline recordings to detect lung fluid build-up and alert their care team.

“The holy grail of the entire [heart failure] monitoring industry is to find a solution that will help a patient know in advance when they’re deteriorating so they can change their diuretics and hopefully avoid hospitalization,” Tal said in an interview.

The Israel-based company is conducting a pivotal study at 30 sites in the U.S. with hopes of winning FDA approval in early 2024. The company already has FDA breakthrough device designation and a CE mark in Europe.

If the company wins FDA approval, Tal said Cordio plans to pursue chronic obstructive pulmonary disease (COPD) and even bipolar disorder.

Until then, Medical Design & Outsourcing asked Tal for a few SaMD development lessons Cordio learned through the development of HearO.


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