FDA recalls Defibtech’s chest compression device following patient death
The US Food and Drug Administration (FDA) has issued a Class I recall for Defibtech’s RMU-2000 ARM XR chest compression…
Anesthesia and Respiratory Devices
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Smiths Medical reports potential issues with tracheostomy tubes
A week after recalling its infusion pumps, Smiths Medical, part of ICU Medical, has sent out an urgent medical device…
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FDA tags Baxter ventilator recall due to charging issues as Class I
The troubled ventilator market has hit another regulatory obstacle after the US Food and Drug Administration (FDA) tagged a recall…
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FDA tags Vyaire’s twin tube recall as Class I
Vyaire Medical has already had a US Food and Drug Administration (FDA)-tagged Class I recall this year, and now the…
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Medline unveils TurboMist small-volume nebuliser
Medline has expanded its respiratory care offerings with the introduction of the new Hudson RCI TurboMist small-volume nebuliser. The new…
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Karius wins FDA breakthrough device designation for lung infection test
Fresh after securing $100m in financing earlier this month, Karius has a regulatory win after the US Food and Drug…
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Nyxoah’s nerve stimulation device meets endpoints in sleep apnoea study
Nyxoah’s hypoglossal nerve stimulation system, Genio, met the co-primary endpoints at 12 months in the pivotal DREAM trial in adults…
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Medtronic exits “unprofitable” ventilator market
Medtronic has called it quits on the ventilator market, citing “increasingly unprofitable” product lines. The medical device giant is the…
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ResMed’s CPAP mask recall tagged as Class I by FDA
The US Food and Drug Administration (FDA) has tagged ResMed’s recall of its magnet-containing Continuous Positive Airway Pressure (CPAP) masks…
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Body Vision signs distribution deals for LungVision
Body Vision Medical has announced exclusive distribution agreements to expand the reach of its LungVision artificial intelligence (AI)-driven imaging system…
