Samay founder and CEO Dr. Maria Artunduaga with the Sylvee device [Photo courtesy of Samay]
“Before the MedTech Innovator win, I was getting tons of technology questions all the time. People didn’t believe our numbers,” Samay founder and CEO Dr. Maria Artunduaga said in a Medical Design & Outsourcing interview. “Right after we won, it was like, ‘OK, let’s talk about the business.'”
Then came the American Thoracic Society’s Respiratory Innovation Summit, where Samay was selected from 300 companies as the innovation success story of 2025 and invited to give a 25-minute presentation to an audience that included Chiesi Farmaceutici executives, Artunduaga said.
Now, Samay and Chiesi have announced a partnership to develop algorithms to detect small airway disease (SAD), which could enable better treatment of chronic obstructive pulmonary disease (COPD).
It’s a nontraditional revenue stream for a device developer and a potential new application for Samay’s wearable Sylvee chest sensor, which the company designed to monitor lung performance in COPD patients. In testing so far, the noninvasive acoustic resonance technology is detecting COPD with 93% accuracy, Artunduaga said.
“We are sending signals through the chest [and] using principles of music to understand what’s going on inside, and we are digitizing all of the frequencies that we are seeing, doing time-series analysis on the frequencies and capturing the resonance,” Artunduaga said. “… We are actually inventing a new way of imaging: imaging the lungs using acoustics. We are not seeing the images or the things inside of a lung, we are making pictures of the sound and how it’s behaving inside.”
Samay plans to launch its Samay wearable in Colombia in 2028. [Photo courtesy of Samay]
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“Honestly, because of what’s going on right now with FDA, NIH and everything, we are actually planning on launching in Latin America first. The regulatory hurdles are way lower, and the regulatory agencies and governments want us to launch in Latin America. … The need is so large in emerging economies for respiratory diagnostics in general, because the technologies are prohibitively expensive.”
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Samay plans to launch its technology in Colombia, where there are 52 million people but only 50 spirometry machines for testing pulmonary function.
“The technology that exists today has so many challenges. We need something that is easier for patients,” she said. “… In the clinical trials that we are doing in Colombia right now for exacerbation detection, 80% to 90% of the patients don’t have any spirometry information. There’s a huge need.”
The plan is to complete development and regulatory review of a point-of-care diagnostic product for primary care physicians and pulmonologists to launch in Colombia in 2028 and learn more about marketing, selling and implementing the technology.
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“We’re working through the FDA for clinical trials here in the U.S., and we will go after FDA clearance probably in 2028,” she said, with plans to resubmit for breakthrough designation before the end of 2025.
“Everything that we are building is always following American standards. … It will make it easier to expand globally,” she said.
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