The FDA has issued an emergency use authorization for the Puritan Bennett 560 (PB560) ventilator, according to Medtronic, 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 for the PB560 to promote rapid ventilator manufacturing and more than 90,000 registrations for the design specifications have been submitted.
Medtronic has also issued a limited market release of a new remote management capability for its Puritan Bennett 980 (PB980) ventilator with two hospitals in the US.
This remote management capability — accelerated by collaborating with Intel Corporation — enables clinicians to adjust the ventilator settings outside of the ICU and away from the patient, which may reduce healthcare worker and clinician exposure to patients recovering from COVID-19, Medtronic said in a statement.
If the feature is well received, the limited market release will be expanded to other US customers later in April, according to the company.