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FDA grants emergency nod to ventilators from Medtronic, other companies

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APRIL 9, 2020 BY NANCY CROTTI LEAVE A COMMENT


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The Puritan Bennett 560 (PB 560) ventilator [Image courtesy of Medtronic]


The FDA has granted four companies’ ventilators emergency use authorization this week to treat COVID-19 patients, as well as a fifth company’s anesthesia gas machine for use as a ventilator.

Gaining the latest EUAs were machines by Medtronic (NYSE:MDT), Draeger, MEK-ICS, Ventec Life Systems, and startup CoLabs.

One of those EUAs went to Medtronic’s Puritan Bennett 560 ventilator, the same machine whose design the company made public in March. Fridley, Minn.-based Medtronic said yesterday that it expects the PB560 will be available in the U.S. in May. Introduced in 2010 and currently sold in 35 countries around the world for an average price of $10,000 apiece. Medtronic described the PB560 as a compact, lightweight, and portable ventilator that can be used in clinical settings and at home.

Medtronic also said the open-source plans for the PB560 have been downloaded 90,000 times, and that it has made “meaningful progress” with three open-source manufacturers, including Baylis Medical in Ontario, Canada, Taiwan-based Foxconn Technology Group at its plant in Mount Pleasant, Wis., and Vingroup in Hanoi, Vietnam.

Fridley, Minn.-based Medtronic also said it has deployed remote management capability of its Puritan Bennett 980 ventilator to two unidentified U.S. hospitals, with help from Intel. The new capability will enable clinicians to adjust the ventilator settings outside of the intensive care unit and away from the patient, which may reduce healthcare worker and clinician exposure to patients recovering from the virus. If the feature is well received, the company said it may offer it to other U.S. customers later in April.

In all, Medtronic said it is shipping more than 300 ventilators per week to customers in the the highest-risk, highest-need locations in the world, with a focus on the PB980 and PB560 models. The company expects to ship more than 400 ventilators per week by the end of April, over 700 per week by the end of May and more than 1000 per week by the end of June. Over the next 6 months, Medtronic expects to produce more than 25,000 ventilators.

https://www.massdevice.com/fda-grants-emergency-nod-to-4-companies-ventilators/
 
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