OSMedTech 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.
Maxim Biomedical, IncFrom its Rockville, Maryland facility, Maxim Biomedical develops and manufactures diagnostic tests while helping healthcare companies and government agencies move assays from concept to commercial production. Founded more than 20 years ago, the family-led company produces millions of tests each month in an FDA-registered, ISO 13485:2016-certified operation with capacity exceeding 15 million devices monthly. Its own products include HIV surveillance assays and the ClearDetect COVID-19 Antigen Home Test, alongside contract development and manufacturing for partners worldwide.ROCKVILLE, MD
Instrumentation Industries, IncSince 1967, Instrumentation Industries, Inc. has manufactured respiratory-care and other medical components in Pittsburgh, including the adapters, connectors and emergency ventilation parts used in clinical settings. The company molds plastic and silicone and fabricates metal in-house, supporting OEM customers from prototypes through production with its own tooling, machining, engineering and assembly capabilities. Its products are made in the USA, and the facility is ISO 13485:2016 certified.BETHEL PARK, PA
Novel Microdevices, IncBaltimore-based Novel Microdevices develops portable, sample-to-answer molecular diagnostic systems built around disposable microfluidic cartridges. Its battery-powered Novel Dx platform is designed to deliver lab-quality PCR results in about 15 minutes, including testing for respiratory infections and other diseases at the point of care. The company is establishing a GMP-compliant pilot manufacturing facility at its Baltimore headquarters to scale cartridge production.BALTIMORE, MD
ScopemedScopemed is a Brunswick, Ohio medical-device company founded by certified anesthetist Tosan Ugbeye and aerospace engineer Shawn Iravanchy. Drawing on clinical and engineering experience, it develops respiratory-care solutions for hospitals and procedural settings, including its O2rizon™ mask for non-invasive oxygen delivery and airway support.BRUNSWICK, OH