Medical Device Network on MSN
FDA hits Philips with warning over manufacturing site deficiencies
In a letter to Philips’ CEO, the FDA cited quality system issues at three of Philips’ manufacturing sites, and failures over ...
The U.S. FDA’s Quality Management System Regulation (QMSR) is not technically in force until Feb. 2, 2026, but a new draft guidance from the agency’s device center seems to indicate that there is a ...
Cash and investments are sufficient to fund current operations through Q2 2027, not including VenoValve commercialization and ...
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