Founded in 2015 by Dr. Ramanan Laxminarayan, HealthCubed India develops portable point-of-care diagnostic systems that screen for more than 55 health parameters. Its HealthCube XL and SE devices are designed for rapid testing in clinics, health camps and remote areas, operating with minimal training and without electricity or internet. The company says more than one million beneficiaries have been registered in its ecosystem and 2.5 million tests have been performed across four continents.
ISO 13485:2016
CE Certification
DCGI/CDSCO Approval
Registration
Indian Medical Rules, 2017
Compliance program
CE
Quality certification
First Diagnostic CorporationFirst Diagnostic Corporation develops rapid point-of-care diagnostic systems and helps other medical-device manufacturers bring diagnostic technologies to the U.S. healthcare market. Founded in 2004 as a medical-device manufacturer, the privately held company now combines its own rapid-test brands with sales representation, distribution, marketing, and customer support for partner manufacturers. Its eight-person operation maintains government and military program relationships and cites GMP and ISO 9001 quality standards.NEW YORK, NY
Prompt DiagnosticsBaltimore-based Prompt Diagnostics develops portable molecular diagnostic platforms that bring laboratory-quality PCR testing to the point of care, with results in under 20 minutes. Co-founded by biomedical engineer Alex Trick and Johns Hopkins professor Tza-Huei (Jeff) Wang, the company built its platform around magnetofluidic cartridge technology invented during Trick’s doctoral research. Prompt is applying that technology to infectious-disease testing, including work on HIV, syphilis, and drug-resistant gonorrhea in low-resource settings.BALTIMORE, MD
Kalix TechnologiesKalix Technologies develops portable molecular diagnostic systems that let farmers and veterinarians test animal, food, water, and agricultural samples on-site in about an hour. Based in Centerville, Ohio, the company combines PCR testing with automated analysis and cloud-based data tools, including a compact unit that can process up to 16 samples at once. Kalix was selected for the AgLaunch365 accelerator and received support through Ohio’s Third Frontier Technology Validation and Startup Fund.DAYTON, OH
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