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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.

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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...

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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...

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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...

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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...

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$10 chip changes standard ultrasound into 3D

In a novel adaptation of the chip in your smartphone that tracks how your phone is oriented can turn a $50,000 2D ultrasound machine into an ultrasound with 3D capabilities rivaling that of...

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What You Missed Last Month – August 2018

August was another busy month for the MedTech Industry. From the discussion on medical device taxes to the prospect of 3D printing transforming the healthcare industry, the month was filled with...

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What You Need to Know about FDA’s Draft Guidance on Writing Test Reports

The FDA issued updated draft guidance for submission of test reports and non-clinical bench test performance in premarket submissions in May 2018. As a draft guidance, the FDA is seeking comment...

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Leveraging 3D Printing For Small Hospitals and Device Developers

The Society of Manufacturing Engineers’ (SME) 2018 Annual Report took a deep dive look at medical additive manufacturing, more commonly referred to as 3D printing.

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What You Missed Last Month July Edition

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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