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U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical document submitted by the manufacturer to the FDA before the medical device product enters the US market to prove that the product has the same safety and effectiveness in terms of intended use, design, ...
RemetricHealth, a leading remote patient monitoring (RPM) and telehealth services company that has been serving the healthcare industry for more than a decade, has announced that its telehealth capabilities, in conjunction with its biometric monitoring devices, are helping connect patients and providers in a time when continuity of care can be challenging due to COVID-19. The telehealth model is ...
The company’s proprietary VisionPort™ system combines four instruments into one and is being developed as a disposable device. It enters as a trocar, functions as a laparoscope and deploys as a camera and an instrument channel. The key advantage of VisionPort over current visualization systems is that, for the first time, it gives the ...
Catalytic Products International (CPI) recently completed the installation of a new TRITON Series Regenerative Thermal Oxidizer (RTO) to a USA based pharmaceutical company for the abatement of Volatile Organic Compounds (VOCs). Working closely with the end user’s environmental consultant, CPI provided detailed information and references which convinced the end user and their general ...
Metrohm and Snowy Range Instruments (SnRI) are pleased to announce that the two companies have entered into a strategic alliance. ...
VillageReach, the Seattle-based social enterprise that increases access to healthcare for remote, last mile communities, today announced the launch of openLMIS™, a new open source initiative to improve health system supply chains in low-income countries. VillageReach also announced the third release of its management information system, vrMIS, an integrated component of its logistics programs ...