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:
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.
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.
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.