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Devicemakers that want to ensure enough women participate in their clinical trials should set a clear and prespecified goal and stick to it, experts say. Read More
The new tests will ascertain whether low-dose computed tomography is needed, as well as determine the malignancy status of nodules from LDCT screening. Read More
The study was paused in September after reports surfaced of reduced leaflet motion observations in patients implanted with transcatheter aortic valve devices. Read More
New draft guidance on extrapolating existing data to gain approval for pediatric indications applies to new devices as well as those already approved for adult use, an FDA official says. Read More
Devicemakers won’t have to stage new clinical trials of their devices to gain approval in China if they can demonstrate that they’re basically equivalent to devices already on the market, Chinese regulators say. Read More