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FDA lists proposed guidance publications for 2019

The FDA issued its list of proposed guidance publications for 2019 on Oct. 5 as part of its agreement to speed approvals of medical devices in exchange for additional funding from industry.

What You Missed Last Month September

September was a busy month for the 3D printing industry. There has been new insight on additive manufacturing and how to handle the latest Medical Device Regulation, a woman’s collapsed ankle was restored with a 3D printed ankle implant, and a new report shows that the medical additive manufacturing field will see significant growth in the coming years. Here is a quick look at what you missed last month:

Emerging AI Applications in Medical Devices

In April, the U.S. FDA issued its first marketing permit for a medical device using artificial intelligence to detect greater than mild diabetic retinopathy. While it was the first such AI approval, it promises to be just the beginning of AI medical devices.

 

 

 

 

Shared responsibility for cybersecurity of medical devices widely recognized

The FDA issued a warning about vulnerabilities of medical devices to cybersecurity threats in a press release on Oct. 1, 2018 and is taking steps to help organizations improve cybersecurity of their medical devices.

 

 

 

 

 

Playbook sets framework for dealing with medical device cybersecurity attacks

Citing the increasing number of cyber attacks in healthcare and concern about the potential for targeting medical devices, the FDA announced in an October 1, 2018 press release the publication of its Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook.

 

 

 

 

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