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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets
The Directory // Respiratory & Sleep

Respiratory & Sleep

Ventilation, sleep apnea, airway and pulmonary devices. 19 companies listed.

London, UK  ·  Unknown  ·  510(k) cleared

Makes AcuPebble, a wearable acoustic sensor worn on the neck that records breathing and heart sounds at home to diagnose sleep apnea.

Singapore  ·  Seed  ·  510(k) cleared

Singapore company behind AeviceMD, a wearable stethoscope for remote respiratory monitoring, plus a cleared software module that flags suspected wheeze in recorded lung sounds.

Menlo Park, CA  ·  Unknown  ·  Breakthrough designation

Builds the BREATHE Airway Scaffold, an implant that relieves pressure in overinflated lungs in severe emphysema without removing healthy tissue. Built at The Foundry and still investigational.

Besançon, France  ·  Est. 2018  ·  Series A  ·  $9M Series A in 2026, after €5.5M in 2022 raised  ·  510(k) cleared

Makes EOlife, a real-time ventilation feedback device that measures the air volume delivered to a cardiac arrest patient's lungs and shows rescuers when to adjust.

Columbia, SC  ·  Pre-seed  ·  In development

Developing an automated cuff-pressure controller for endotracheal and tracheostomy tubes.

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.

Austin, TX  ·  Series A  ·  $75M raised  ·  510(k) cleared

The Happy Ring is a sensor ring cleared to diagnose obstructive sleep apnea at home. The company is building a home care platform around it.

Irvine, CA  ·  Est. 2018  ·  Unknown

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

Menlo Park, CA  ·  Est. 2023  ·  Unknown  ·  510(k) cleared

Builds airway and GI stents, cryo biopsy probes and steerable endobronchial instruments, plus molecular diagnostics for lung cancer triage. Formed under Ajax Health in 2023 and acquired Thoracent in 2025.

Yakum, Israel  ·  Est. 2024  ·  Pre-seed  ·  510(k) cleared

Israeli software startup whose CPETWise platform automates analysis, interpretation and reporting of cardiopulmonary exercise tests. FDA cleared CPETWise under K260242 on August 20, 2026, 206 days after receiving the traditional 510(k).

Galway, Ireland  ·  Series C  ·  510(k) cleared

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

Houston, TX  ·  Series B  ·  510(k) cleared

Makes the Prana System, a single-use image-guided electrosurgical tool that combines CT-guided targeting with tissue excision. It was cleared in April 2026 to remove tissue and control bleeding.

Houston, TX  ·  Pre-seed  ·  In development

Makes PulmVac, a wearable chest drainage device for pneumothorax with real-time pressure monitoring.

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.

San Francisco, CA  ·  Unknown  ·  510(k) cleared

Makes the Kricket positive airway pressure device, which runs its KPAP algorithm to deliver pressure only during parts of the breath cycle rather than holding one fixed pressure.

Irvine, CA  ·  Series A  ·  Submission pending

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

Irvine, CA  ·  Series A  ·  $22M raised  ·  510(k) cleared

Builds the Bonhawa high flow oxygen therapy system for patients with respiratory insufficiency. FDA cleared the system in October 2023.

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.

New Haven, CT  ·  Series B  ·  $10M Series B first tranche raised  ·  510(k) cleared

Runs the Spire remote patient monitoring system with wearable Health Tags for continuous cardiopulmonary tracking, aimed at catching COPD deterioration before symptoms appear.

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