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 Company continues to prioritize securing FDA Investigational Device Exemption (IDE) approval to initiate human clinical studies at Mayo Clinic. Over the past several years, Vivos has successfully ...
Cash and investments are sufficient to fund current operations through Q2 2027, not including VenoValve commercialization and ...
A small FDA survey of nine hospitals found that the most popular use cases for RFID (radio frequency identification) technology are infusion pumps, portable monitors, wheelchairs, beds, and ...
The U.S. FDA’s Quality Management System Regulation (QMSR) is not technically in force until Feb. 2, 2026, but a new draft guidance from the agency’s device center seems to indicate that there is a ...
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