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THE TAPE
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
The Directory // Respiratory & Sleep

Respiratory & Sleep

Ventilation, sleep apnea, airway and pulmonary devices. 6 companies listed.

Galvanize Therapeutics
Redwood City, CA  ·  Est. 2015  ·  Series C  ·  $200M raised  ·  510(k) cleared

Galvanize Therapeutics builds pulsed electric field ablation systems. Aliya is cleared for soft tissue ablation and is being studied in solid tumors; RheOx targets chronic bronchitis.

Profile →galvanizetx.com ↗
Makani Science
Irvine, CA  ·  Est. 2018  ·  Unknown

Makes a wireless patch for continuous breathing monitoring, first aimed at patient safety during procedural sedation.

Profile →makaniscience.net ↗
Neurent Medical
Galway, Ireland  ·  Series C  ·  510(k) cleared

Neurent Medical makes NEUROMARK, a radiofrequency system that ablates the posterior nasal nerves to treat chronic rhinitis.

Profile →neuromark.com ↗
Samay
Mountain View, CA  ·  Unknown  ·  In development

Builds Sylvee, a wearable chest sensor that uses acoustic resonance to measure trapped air and lung volumes at home for people with COPD. Won MedTech Innovator in 2024.

Profile →samayhealth.com ↗
Spiro Medical
Irvine, CA  ·  Series A  ·  Submission pending

Spiro Medical is developing an implantable spinal nerve stimulator to reduce symptoms in severe, uncontrolled asthma.

Profile →www.spiromedical.com ↗
Traferox Technologies
Mississauga, ON  ·  Est. 2021  ·  Unknown  ·  PMA approved

Builds organ preservation and ex vivo lung perfusion systems for transplant, spun out of Toronto General Hospital in 2021.

Profile →traferox.com ↗
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