Founded by Carnegie Mellon alumni, including a pediatric surgeon, PECA Labs develops cardiovascular implantable devices built around a polymer platform and novel designs. The Pittsburgh company makes vascular grafts and heart-valve devices, including the radiopaque exGraft and investigational MASA Valve, whose first-in-human pediatric implant was completed in 2023. PECA Labs is ISO 13485:2016 certified.
ISO 13485:2016 Certified
certification
Neoolife, IncPittsburgh-based Neoolife, Inc. is a pre-clinical Bio-MedTech startup developing tissue-engineered biomimetic heart valves and cardiovascular patches designed to support the body’s own tissue regeneration. Its distinctive Double Component Deposition technology creates non-animal-derived polymeric scaffolds, including the OneValveTric transcatheter tricuspid valve system, while the company’s international team brings more than 130 years of combined biomedical and cardiovascular experience. The technology has received support through NIH and European Research Council grants, but Neoolife’s products remain in research and pre-clinical development and are not yet approved by regulators.PITTSBURGH, PA
NuMEDFounded in a former elementary schoolhouse in Hopkinton, New York, in 1984, NuMED designs and hand-manufactures cardiovascular catheters and stents for patients with congenital heart defects, with a particular focus on pediatric care. The company pioneered its Balloon-in-Balloon technology and works closely with interventional cardiologists to develop tools for challenging procedures, now reaching patients in more than 100 countries. NuMED also provides OEM design and manufacturing services, with every device inspected throughout production and again before distribution.HOPKINTON, NY
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
CircadianceFounded in 2006 near Pittsburgh by medical-device engineer David Groll, Circadiance develops and manufactures respiratory-care equipment and remote patient-monitoring systems. The company is best known for SleepWeaver, the first all-cloth positive-airway-pressure mask, and also supports infant and pediatric care through SmartMonitor and Synergy Cloud products. Circadiance is ISO 13485 certified and distributes its products internationally.EXPORT, PA