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The FDA has requested that Accelerate Diagnostics discontinue marketing and distribution of its Accelerate Arc system and related blood culture kit as they are not Class I devices and therefore not exempt from 510(k) clearance. Read More
Apple has filed a lawsuit against Delaware-based medical device developer Masimo, alleging that the company infringed upon numerous Apple Watch patents with its new W1 smartwatch line. Read More
The FDA’s biggest challenge in protecting medical devices from cybersecurity breaches is legacy technology, says a top agency technology official. Read More
The Center for Devices and Radiologic Health (CDRH) Monday released a priorities list of draft and final guidance documents it plans to publish in 2023, including two final documents focusing on the regulatory transition out of the COVID-19 public health emergency. Read More
The FDA has granted Emergency Use Authorization (EUA) to Winnipeg, Canada-based PADM Medical’s biodegradable, plant-based face mask for use in healthcare and medical settings. Read More