Rethinking 510(k): Studies Show Risk of Using Recalled Devices as Predicates for FDA Clearance
New studies detailed how stronger safeguards are needed to prevent problematic predicate selection of medical devices.
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Search Results for: recall
Philips Respironics Ventilators Get New FDA Recall Notice
The FDA is providing additional information to patients, caregivers, and healthcare providers about two recent issues in certain ventilators.
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MIT Engineers Design a Soft, Implantable Ventilator
A team of engineers from MIT are developing a ventilator solution that will aid people with compromised diaphragm function.
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Smiths Medical Issues Urgent Medical Device Correction for Infusion System
Smiths Medical has issued an Urgent Medical Device Correction Letter for two potential issues with CADDÂ infusion system infusion sets.
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Address Medical Device Vulnerabilities Before It’s Too Late
Healthcare system leaders must prioritize cybersecurity with a strategy that includes addressing medical device vulnerabilities.
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