The FDA has granted emergency use authorisation for MTV-1000 ventilator to be used for the COVID-19 patients
Medical devices maker Biolase has collaborated with an intensive care unit (ICU) equipment manufacturer MEKICS to manufacture and supply ventilators to address the COVID-19 pandemic.
Under the deal, Biolase will use its Food and Drug Administration (FDA)-registered manufacturing facility, located in California, for the manufacturing of MEKICS’s MTV-1000 ICU-grade portable ventilators.
The FDA has granted emergency use authorisation (EUA) for MTV-1000 ventilator to be used for the COVID-19 patients.
MEKICS CEO Jong Cheol Kim said: “Collaborating with the team at BIOLASE, who have years of experience manufacturing, marketing and selling medical equipment in the United States, is a great opportunity for us to provide this much-needed product to the U.S. public.”
MEKICS is engaged in the manufacturing of various respiratory products such as ventilators, while Biolase is involved in the manufacturing and marketing of advanced dental laser systems.
Biolase will manufacture and supply the MTV-1000 ventilator under FDA EUA status
Biolase has secured authorisation to manufacture and distribute the MTV-1000 ventilator as part of the FDA EUA status, as well as an exemption from the California state to operate, market and produce the critically required ventilator.
The company intend to apply years of expertise in manufacturing FDA-cleared medical equipment to meet the increasing demand for ventilators and support the global backorder on ventilators during the COVID-19 crisis.
The MTV-1000 is a field-tested, ICU-level and portable ventilator, which includes pressure-control and internal positive end-expiratory pressure (PEEP) features.
Biolase CEO Todd Norbe said: “Without hesitation, we expect to pivot quickly and leverage our FDA-registered facility for the manufacturing and delivery of the MTV-1000 ventilator and have already received over $10 million in orders.”
In February 2017, Biolase secured 510(k) clearance from the FDA for its Waterlase Express all-tissue laser system.