FDA Authorizes Medtronic PB560 Ventilator in US | 合法醫療器材資訊網

2020年4月16日—Introducedin2010andcurrentlysoldin35countriesaroundtheworld,thePB560isacompact,lightweight,andportableventilatorthatcanbe ...

The FDA has issued an emergency use authorization for the Puritan Bennett 560 (PB560) ventilator, according to Medtronic[1], which said the ventilators will be available in the US in May.

Introduced in 2010 and currently sold in 35 countries around the world, the PB560 is a compact, lightweight, and portable ventilator that can be used in clinical settings and at home. The PB560 ventilator average selling price is under $10,000 USD, according to Medtronic.

“This FDA decision allows Medtronic to provide another ventilator option to doctors and clinicians in the US for patients with COVID-19,” the company said in a statement.

In March, Medtronic publicly shared the design specifications[2] for the PB560 to promote rapid ventilator manufacturing and more than 90,000 registrations for the design specifications have been submitted.

Medtronic has al...