NSV Inc. makes portable, AI-driven healthcare screening devices that help clinicians detect cervical and oral pre-cancer and heart abnormalities earlier. Based in Allentown with offices in India, the company combines guided digital workflows, proprietary imaging and analysis algorithms, and secure cloud sharing to deliver immediate, more consistent screening results. Its nGyn cervical screening system is a Class II FDA-exempt digital colposcope, manufactured in compliance with ISO and GMP standards required by the FDA.
Class II FDA Exempt Device under PTZ designation
ISO and GMP manufacturing compliance
Compliance program
FDACLASSIIEXEMPTDEVICE
Quality certification
ISO
Quality certification
GMP
Quality certification
UE LifeSciences IncFounded in 2009, UE LifeSciences develops hand-held medical devices and digital tools that make early cancer detection more accessible, starting with its FDA-cleared iBreastExam for quick, painless, radiation-free breast-lump screening. Its Philadelphia-rooted, globally distributed team designs systems for community health workers and has supplied more than 2 million breast exams across 10 markets, with newer tools extending screening to cervical and oral cancer. The company also established an ISO 13485- and WHO-GMP-certified manufacturing facility in India as it expanded internationally.WEST CHESTER, PA
AI OpticsAI Optics develops portable retinal-imaging hardware and AI-based screening software that brings eye-disease screening into primary care, retail health, home-based care, and other point-of-care settings. Founded by an NYU-trained physician who saw the consequences of limited screening access, the company built its FDA-cleared Sentinel Camera from scratch and is developing Sentinel Pro to run disease-screening modules directly on the handheld device. The New York-based team combines medical-device engineering experience with expertise in optical systems, embedded devices, and AI algorithms.NEW YORK, NY
OnMed LLCOnMed builds patented 8-by-10-foot CareStations—“Clinics-in-a-Box” that combine diagnostic equipment with real-time licensed clinicians to deliver non-emergency healthcare where people live, work, and learn. Its plug-and-play stations blend in-person examination with telehealth, using AI-supported technology while keeping care human-delivered, and can be deployed with an electrical outlet in as little as 45 days.WHITE PLAINS, NY
Lutech MedicalLutech Medical develops digital colposcope systems for women’s health, forensic medicine, and related clinical imaging, with more than two decades of experience in the colposcopy market. Woman-led and privately owned in the United States, the company introduced what it describes as the world’s first fully mobile high-definition colposcope, extending cervical exams and documentation to outreach and remote settings. Lutech supports its equipment with U.S.-based service, training, and a presence in eight countries.RONKONKOMA, NY