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Manila Bulletin devider Technews devider Non-Invasive Ventilator Solution Certified by FDA

Non-Invasive Ventilator Solution Certified by FDA

Published Aug 11, 2020 09:21 am

Integrated Micro-Electronics Inc. Philippines, a global multinational company with Filipino roots has officially received certification from the Food and Drug Administration (FDA) for its UCL Ventura Flow Generator, a non-invasive ventilatory support in the management of COVID-19 patients.

The device is a continuous positive airway pressure (CPAP) solution that applies constant steady air pressure and effectively supports patients with breathing difficulties. It was developed based on an existing off-patent CPAP system specifically for the management of those infected with corona virus and at the same time optimize oxygen consumption.  The UCL Ventura is licensed from the University College London (UCL) Hospital and Mercedes-AMG High Performance Powertrains with approval from UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).  The MHRA is the executive agency of UK’s Department of Health and Social Care responsible for ensuring that medicines and medical devices work and are safe to use.

With the FDA certification, IMI Phils. now has the license to manufacture the UCL Ventura Flow Generator to support the government’s call for local outsourcing and manufacturing of low-cost ventilators and other breathing aid solutions in caring for COVID-19 patients. The company passed the inspection audit conducted by the FDA last July 10, 2020.

IMI is commemorating its 40th anniversary this month.

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