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The FDA issued updates on recalls of Datascope/Getinge’s Cardiosave Hybrid and Rescue intra-aortic balloon pumps (IABP) and certain Emergent reactive skin decontamination lotion (RSDL) kits, declaring them to be Class 1 recalls because of the “reasonable probability” that use of the devices could cause serious harm or death.
The device makes it “possible to uncover elevated risk for these complications earlier and more accurately than traditional clinical approaches,” the company said.
Diabetes nonprofit organization Tidepool has received FDA clearance for its crowd-sourced Tidepool Loop, the first automated insulin dosing app that works from an Apple Watch.
Light Age received a Form 483 for multiple deficiencies observed in an inspection of its Somerset, N.J., facility including the lack of a device master record and failing to launch corrective and preventive action (CAPA) procedures.
Healthcare analytics company Aetion has entered into a five-year collaboration with the FDA to use its Aetion Evidence Platform (AEP) to analyze novel oncology real-world data and answer questions about cancer prevention, clinical care, diagnostics and treatment.