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The FDA has issued an 8-observation Form 483 to Hampton Medical Devices, based on an inspection last November of the company’s manufacturing facility in Festus, Mo. Read More
Roche and Bristol Myers Squibb (BMS) are teaming up to use artificial intelligence (AI) to support the use of two assays in clinical trials for tumor treatment. Read More
The Advanced Medical Technology Association (AdvaMed) is leading the device industry in asking the FDA to go slow on its transition from pandemic-era authorization approaches to more normal operating status. Read More
The agency said NeuroOne may re-submit a new 510(k) application if it has biocompatibility data to show its device to be substantially equivalent. Read More
The FDA’s supervision of device safety is in the congressional crosshairs following last June’s recall of Medtronic’s HeartWare Ventricular Assist Device (HVAD) System. Read More
The FDA is considering how to offer more regulatory flexibility for medical device software, said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH). Read More
The company is planning a limited U.S. market release of the 027 micro-catheters in the second quarter of this year, with the 021 micro-catheters platform to follow shortly afterwards. Read More
The test provides qualitative detection of RNA from the SARS-CoV-2 virus in nasopharyngeal and nasal swab specimens with RT-PCR in 17 minutes or less. Read More