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Latest From Ferdous Al-Faruque
The US agency is engaged with an ethylene oxide (EtO) sterilizer in Illinois that has temporarily closed to determine if there are any potential risks to the medical device supply chain. While the plant shut down about a month ago, regulators have only recently been made aware of the decision, which resulted from a law passed last year by the state legislature.
After an eleventh-hour win last year that saw Congress repeal the medical device excise tax, AdvaMed is going more global. CEO Scott Whitaker sat down with Medtech Insight for a lengthy chat about what the lobby group will focus on in 2020, including reimbursement challenges, the upcoming medical device user-fee negotiations, and negotiations with governments that are key to the industry ecosystem.
Following closely on the heels of a medical device tax repeal win, AdvaMed CEO Scott Whitaker sat down with Medtech Insight to discuss how the industry advocacy group ended the Obamacare excise tax and what it has in store for 2020.
US regulators and GE have notified health-care providers that the company’s nurse bay monitoring stations could be attacked by malicious hackers to turn off critical alarms that are intended to alert caregivers when a patient is in a critical state.
After getting the greenlight to sell the Exalt D single-use duodenoscopes in the US, Boston Scientific has received a CE mark for the device in Europe. The first of its kind, the surgical diagnostic device is intended to help reduce risks of infections.
To mesh with a final order reclassifying medical-image analyzers, the US agency has also published a final guidance on computer-assisted detection (CADe) devices that was first finalized more than six years ago.