US FDA Warns Of Safety Concerns For Bed Rails And Infant Incubators
In recent announcements, the US agency alerted the public to potential risks associated with gases emitted by infant incubators, as well as safety concerns related to adult portable bed rails.
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MDSAP Audit Allows Emerging Firm To Expand Internationally
Blood-collection technology firm Tasso has been recommended for certification by MDSAP. The international qualification is part of a push to offer the company’s technology in countries such as Australia and Canada, CEO Ben Casavant told Medtech Insight.
FDA’s Power Morcellation Containment System Guidance Doc Finalized
The US FDA has finalized a guidance document that details performance assessment standards for power morcellation containment systems. The class II devices have been an object of special scrutiny since the agency learned that power morcellation could spread cancerous tissue throughout the body.
EPA Gives Stakeholders Additional 15 Days For EtO Comments
The deadline for comments on the Environmental Protection Agency proposal, which trade groups say could lead to device shortages if implemented, has been moved from 12 June to 27 June.