FDA has requested that a PMA for Boston Scientific’s Watchman left atrial appendage closure device for stroke-prevention be subject to another advisory panel meeting -- the third since 2009 -- which will delay the launch to, at earliest, the first half of 2015, the company says.
Boston Scientific Corp. says its Watchman stroke device won’t be available in the U.S. until next year at the earliest now that FDA wants the device to undergo its third advisory panel meeting in five years.
The firm’s Chief Financial Officer Dan Brennan provided the updated during a June 17 discussion at the Wells Fargo Health Care Conference in Boston.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
Mirvie launched Encompass, a blood test to help identify women over age 35 who are at moderate risk for preeclampsia, and will conduct additional studies to support reimbursements from payers.
Israeli-based SpotitEarly hopes to bring an early cancer-detection test, which uses dogs’ noses to detect compounds in exhaled breath and AI analysis, to US homes in 2026.
