Medical device maker Medtronic has won Food and Drug Administration approval to immediately market a lower-cost ventilator to meet increased demand because of the coronavirus outbreak.
Medtronic wins FDA approval to market lower-cost ventilator in U.S.
The medical device maker earned FDA approval for the PB560 and will work with other firms to launch in May.
April 10, 2020 at 2:37AM
The ventilator, the Puritan Bennett 560, is currently sold in 35 countries at an average price of under $10,000, the company said late Wednesday. It plans to launch the ventilator in May.
As U.S. demand for ventilators skyrockets because of the fast-spreading pandemic, the government is pushing makers to boost their production capacities and has mandated carmakers to use their facilities to produce the device.
The U.S. Health and Human Services Department on Wednesday awarded two contracts worth more than $1 billion to General Motors Co. and Philips and plans to announce five additional contracts later this week.
Medtronic, whose operational headquarters are in Fridley, said it expects to ramp up production nearly fivefold to more than 1,000 ventilators per week by the end of June and make over 25,000 devices available over the next six months.
The company said it was testing a new feature for its higher-end Puritan Bennett 980 ventilator with two U.S. hospitals that would allow clinicians to adjust settings remotely, reducing physicians' exposure to patients with COVID-19, the disease caused by the coronavirus.
During the week of March 30, Medtronic said it started publicly sharing the design specifications for the PB560 to enable participants across the globe to evaluate options for rapid ventilator manufacturing.
The company said it is making "meaningful progress" with three manufacturers: Taiwanese electronics manufacturer Foxconn Technology Group; Baylis Medical Company Inc. in Mississauga, Ontario; and Vingroup Joint Stock Company in Hanoi, Vietnam.
Foxconn, best known for assembling Apple's iPhones at factories in China, said Wednesday in a statement released through company founder Terry Gou's office that medical and technical personnel from both firms were working closely on the ventilators.
The companies hope to speed production time so the ventilators can be put to work as soon as possible, it added.
Medtronic CEO Omar Ishrak told CNBC that Foxconn's Wisconsin plant would be used to make the ventilators.
about the writer
The governor said it may be 2027 or 2028 by the time the market catches up to demand.
