Founded in Toronto in 2012 by cancer-imaging researcher Dr. Ralph DaCosta, MolecuLight develops handheld medical imaging devices for point-of-care wound assessment. Its MolecuLight i:X and DX systems use fluorescence imaging to help clinicians locate elevated bacterial loads and digitally measure wounds, with DX also providing non-contact thermal imaging. The privately owned company operates under an ISO 13485:2016 quality management system and has FDA-cleared devices.
ISO 13485:2016 Quality Management System
SOC 2 Type 1 Accreditation
Compliance program
FDA Clearance
Registration
Health Canada Approval
Registration
CE Marking
Registration
CE
Quality certification
GWR Medical, IncFounded in 1996 in Chadds Ford, Pennsylvania, privately owned GWR Medical develops FDA-cleared topical oxygen therapy devices for hard-to-heal open wounds and burns. Its home-based TO2 treatment is paired with WoundMatrix, the company’s wound-imaging and measurement technology, to help clinicians and insurers track healing remotely. GWR says its therapy has been provided to 15,000 patients and has been used by the Department of Defense and Veterans Administration.CHADDS FORD, PA
Akrotome ImagingIncorporated in Delaware in late 2008, Cleveland-based Akrotome Imaging develops fluorescent molecular probes that help surgeons see cancer and its margins during resection. Its patented FIRE platform uses quenched probes that activate when they encounter tumor-associated enzymes, with the flexibility to be applied in the operating room and used alongside a near-infrared imaging system. The company’s current team has been in place since 2012 and is translating the technology toward breast and non-melanoma skin cancer applications.CLEVELAND, OH
Bechtel Medical, IncFounded by healthcare entrepreneur John M. Gvodas Jr., Bechtel Medical designs, develops, and manufactures medical devices focused on wound care. The Phoenixville company brings engineering and clinical insight together in technologies such as its VOX Negative Pressure Wound Therapy System, with patient safety, quality, and regulatory discipline at the center of its work.PHOENIXVILLE, PA
Cork Medical, LLCFounded in 2007, Cork Medical designs and manufactures medical devices for wound treatment and prevention, with a particular focus on negative pressure wound therapy. The Indianapolis company began as an NPWT and specialty-mattress distributor before building clinical and engineering teams to develop its own Nisus system, creating products shaped by clinician needs. Its manufacturing facility is certified to ISO 13485:2016 through the Medical Device Single Audit Program, and its products are distributed across the United States and internationally.COLUMBUS, OH