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The FDA is planning to reclassify HIV viral load monitoring tests from high-risk class III devices requiring premarket agency approval into lower-risk class II devices requiring special controls and a premarket notification. Read More
Smiths Medical has received three complaints alleging deaths and seven complaints for serious injury due to malfunctions of its Medfusion pumps that it was slow to act on, the FDA said in a warning letter. Read More
The global market for smart medical devices will increase at a compound annual growth rate of 14.6 percent through 2026, to a total of $286 billion in 2026 from $110 billion in 2019, according to an analysis by ResearchAndMarkets.com. Read More