FDA Approves First Continuous Glucose Monitoring System Not Requiring Blood Sample Calibration

posted in FDA by Kapstone Medical

The FDA approved last July the first continuous glucose monitoring system that could free millions of people with diabetes from daily finger sticks.

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26 Dec, 18

FDA's ASCA Pilot Program

posted in FDA by Kapstone Medical

Agency publishes details for conformity assessment

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published additional information on its pilot..

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20 Dec, 18

FDA lists proposed guidance publications for 2019

posted in FDA, medical devices, Regulatory by Kapstone Medical

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.

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30 Oct, 18

What You Missed Last Month September

posted in 3D Printing, medical devices, FDA, Regulatory by Kapstone Medical

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..

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29 Oct, 18

Emerging AI Applications in Medical Devices

posted in AI, Artificial Intelligence, medical devices, FDA by Kapstone Medical

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..

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23 Oct, 18

Shared responsibility for cybersecurity of medical devices widely recognized

posted in medical devices, cybersecurity, FDA by Kapstone Medical

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..

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22 Oct, 18

Playbook sets framework for dealing with medical device cybersecurity attacks

posted in cybersecurity, medical device, FDA by Kapstone Medical

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..

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18 Oct, 18

What You Need to Know about FDA’s Draft Guidance on Writing Test Reports

posted in FDA by Kapstone Medical

The FDA issued updated draft guidance for submission of test reports and non-clinical bench test performance in premarket submissions in May 2018. As a draft guidance, the FDA is seeking comment..

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24 Sep, 18

What You Missed Last Month July Edition

posted in medical devices, 3D Printing, FDA by Kapstone Medical

Lots has happened in the MedTech Industry since last month. New EU Medical Device Regulations continue to pose as a threat to additive manufacturing, the FDA is urging companies to go paperless,..

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29 Aug, 18

FDA’s Strategic Policy Roadmap for 2018

posted in FDA, 510(k), medical devices by Kapstone Medical

FDA Commissioner aims to streamline review and beef up technical support

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25 Apr, 18

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