The FDA has issued three new draft guidances related to the 510(k) submissions program, including Best Practices for Selecting a Predicate Device, Use of Clinical Data in Premarket Notification and Evidentiary Expectations for Implant Devices. The agency is accepting comments and will host a webinar for stakeholders on October 26, 2023, to provide more information on the guidances.
FDA also supports the removal of the HeartWare HVAD System from the market.
Bayer’s second quarterly analysis report of adverse event information includes nearly 12,000 serious injuries, 45 malfunction reports and nine deaths.
The adoption of this manufacturing process in healthcare saw a tremendous uptick in 2020.
When a device is implanted in a human body, there is always a distinct reaction of the body’s immune system, often resulting in a thick layer of scar tissue surrounding the implant. With device miniaturization and by providing a ‘biomimetic’ device encapsulation, this body reaction will be reduced.
Cost justification and lack of material compatibility continue to create hurdles, but industry stakeholders have been coming together to help drive innovation.
How to improve medical device security and the importance of security updates.
While the terms rapid prototyping, additive manufacturing, and 3-D printing are used interchangeably these days, biofabrication is setting itself apart.
Researchers are studying a new biomaterial that helps healthy cells adhere to the implant, fend off bacterial cells and thus, reduce the likelihood of the implant being rejected by the body.