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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

Deal

Chiesi pays Samay to build small airway disease detection into Sylvee

MedDevice Startups Staff · Oct 9 · 2 min read · Via MassDevice

Samay signed a paid development deal with Chiesi, the Parma drugmaker, to build small airway disease detection into its Sylvee wearable, reported October 9, 2025. Chiesi funds the algorithm work and an initial pilot study, with results expected by April 2026. No equity changes hands.

Sylvee is a chest sensor that reads acoustic resonance to measure air trapped in the lungs, then applies AI analysis to track lung volumes, respiratory rate and breathing sounds. Founder and CEO Maria Artunduaga said air trapping serves as a proxy for small airway disease, which precedes irreversible COPD progression. The company works out of Mountain View with operations in Colombia, and is targeting FDA clearance in 2028 with a Colombian launch first.

Samay won MedTech Innovator in 2024, the first Latin American startup to do so. A pharma company paying for algorithm development is a better outcome than a logo slide: non-dilutive money, a clinical partner, and a use case the company had not built for.

Questions & Answers

What did Samay and Chiesi agree to do?

Chiesi is paying Samay to develop algorithms that detect small airway disease using the Sylvee wearable sensor, and to run an initial pilot study. Results were expected by April 2026. Chiesi took no equity stake.

What is Samay's Sylvee device?

Sylvee is a wearable chest sensor that uses acoustic resonance and AI analysis to measure air trapped in the lungs, along with lung volumes, respiratory rate and breathing sounds, for COPD monitoring at home.

When does Samay expect FDA clearance for Sylvee?

Samay is targeting FDA clearance in 2028, with a launch in Colombia planned first, according to founder and CEO Maria Artunduaga.

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