Australian company Endogene Ltd develops and commercialises medical technologies, including the Parascope self-propelling endoscope designed to advance through the gastrointestinal tract without conventional pushing. Its work also includes less-invasive vascular surgery systems, with products developed under an ISO 13485:2016 quality system and supported by an international patent portfolio. Endogene is an unlisted Australian public company funded through private investment, grants and R&D tax concessions.
ISO 13485:2016 Quality Standard for the Manufacture of Medical Devices
compliance_program
IDE GroupIDE Group is an entrepreneurial medical-technology partner that designs, engineers, manufactures and commercialises healthcare products and ventures. Its cross-disciplinary team works across the full journey from problem discovery to market launch, with particular depth in regulated medtech and more than 20 years of respiratory-device experience. With ISO 13485:2016-certified operations in Australia and the Netherlands, IDE has helped bring products such as Bayer’s MEDRAD Centargo CT Injector and its own OKO ophthalmic auto-injection system toward market.NEWTOWN SQUARE, PA
EndolumikBorn from Dr. Nova Szoka’s experience performing bariatric surgery at West Virginia University, Morgantown-based Endolumik develops surgical devices that illuminate gastric calibration tubes during minimally invasive gastrointestinal procedures. Co-founder Mara McFadden and Dr. Szoka created its patented fluorescence-guided system to give surgeons a clearer view of the bougie while shaping gastric sleeves and pouches. The company’s Gastric Calibration Tube was the first device authorized under the FDA’s Safer Technology Program.339112PITTSBURGH, PA
Saneso IncSaneso Inc. is a medical technology company headquartered in Pittsburgh, PA, dedicated to improving patient outcomes through the development of next-generation endoscope systems. The company's groundbreaking five-camera endoscope platform provides a 360° integrated view of the gastrointestinal tract, addressing the limitations of traditional colonoscopes.PITTSBURGH, PA
Wassenburg MedicalFounded in 1984 by Gerrit Wassenburg, Wassenburg Medical develops and manufactures automated endoscope reprocessing systems for the safe cleaning and disinfection of flexible endoscopes. The business grew from a family company into a specialist represented in 35 countries, and its end-to-end approach extends from reprocessing equipment to traceability and supporting services. Its development and manufacturing organisation is ISO 13485 certified, with WASSENBURG® washer-disinfectors tested against ISO 15883 requirements.IVYLAND, PA