Roche Wins FDA Authorization On High-Volume Monkeypox Test
The test, which is the first for the condition to win an EUA using actual patient samples, provides results in about three and a half hours.
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Abbott Gets First Monkeypox Test EUA For Commercial Use
The US Food and Drug Administration has granted Abbott emergency use authorization for its monkeypox test, making it the first diagnostic to detect the virus to become commercially available.
News We’re Watching: SALSA Reintroduced, FDA Approves Abbott Valve, Metallic Implant Study
A bill aimed at preventing laboratory reimbursement cuts has been reintroduced in the US Congress. Additionally, an Abbott valve landed FDA approval, On Target Labs reported trial results, and the FDA warned that dental palate expanders may pose health risks to adults.
HHS Watchdog Blesses Proposed Gift Card Giveaway To Encourage Test Returns
A proposal that would give some patients gift cards in exchange for returning a screening test sample would not violate anti-kickback law because it doesn’t encourage medically unnecessary services, HHS-OIG says.