Spun out of Cleveland Clinic engineering work in 2018, VisionAir Solutions makes patient-specific silicone airway stents designed from each patient’s CT scan and physician-approved airway model. Its Cleveland, Ohio team combines cloud-based 3D stent design with in-house manufacturing, producing FDA-cleared devices for central airway obstruction and shipping them to medical centers in four to six business days. More than 900 stents have been created for use by pulmonologists at medical centers across the United States.
FDA clearance for VisionAir 3D Stent Architect v2.0.0
FDA-cleared indications for symptomatic central airway obstruction
Compliance program
FDA
Quality certification
Kallisio, IncKallisio develops patient-specific medical devices for oncology, led by Stentra™, an FDA-cleared and CE-marked intraoral device custom-made for head and neck radiation therapy. Designed from a patient’s oral scan and delivered within 72 hours, Stentra™ helps position the tongue and protect healthy tissue without disrupting standard clinical workflows. The Baltimore company is building a broader pipeline of personalized precision-care solutions with clinicians and medical centers.BALTIMORE, MD
Bryan MedicalFrom Cincinnati, Bryan Medical develops and supplies airway-management devices and other ENT medical products for pediatric and adult care. Its physician-collaborative portfolio includes distinctive systems such as the Aeris airway dilation catheter and Tenax laser-resistant endotracheal tube, while its place in the SPIGGLE & THEIS Group extends its U.S. offering to German-engineered ENT instruments. Bryan Medical also represents Reliance Medical products in Ohio and Kentucky and holds nationwide GSA contracts.CINCINNATI, OH
Respair, IncBorn from University of Pittsburgh clinical research, Pittsburgh-based Respair develops airway devices for ventilated patients, beginning with RelianceET, a breathing tube designed to replace the conventional inflatable cuff with soft baffles that seal the airway without added pressure. Founded by physicians Carl Snyderman and Garrett Coyan, the company brings surgeons, engineers, and entrepreneurs together to address ventilator-associated complications. Respair completed hundreds of benchtop tests and received a Phase I SBIR award from the NIH while advancing the device toward regulatory submission.PITTSBURGH, PA
OSMedTechOSMedTech develops and manufactures respiratory diagnostic solutions, with a focus on multiplex testing for over-the-counter and point-of-care use. Its facility includes three GMP-grade clean rooms and two automated production lines, supporting stated monthly capacity of 300 million lateral-flow assay units. The Cleveland-based company is designing the platform for U.S. manufacturing and domestic supply-chain resiliency.CHAGRIN FALLS, OH