Playbook sets framework for dealing with medical device cybersecurity attacks

posted in cybersecurity, FDA, medical device 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

NSF International offers online learning for MDSAP program

posted in 510(k), medical device, Quality by Kapstone Medical

The National Sanitation Foundation (NSF) has produced a series of online training courses for regulatory compliance officers and auditors involved with regulatory processes working in the medical..

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27 Jul, 18

ACA tax has $665 million impact on medical device industry

posted in medical device, tax, ACA, Affordable Care Act by Kapstone Medical

A new study has found the excise tax on medical devices enacted as part of the Affordable Care Act had a $665 million impact on the medical device industry, according to an Iowa State University..

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24 Jul, 18

FDA Reconfirms Continued Acceptance of Single Audits

posted in FDA, medical device by Kapstone Medical

In an update to its review of the International Medical Device Regulators Forum report the FDA in December reconfirmed that it will continue to accept results of the Medical Device Single Audit..

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09 Feb, 18

What You Missed With the New Year Tax Reform

posted in medical device, tax reform, tax by Kapstone Medical

Did Republicans forget the medical device tax?

When all the dust had settled following the passing of the Tax Cut and Jobs Act, the $1.5 trillion Republican tax overhaul, the medical device..

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17 Jan, 18

FDA’s Advice for Medical Device Interoperability

posted in medical device by Kapstone Medical

The FDA issued its final guidance for medical device interoperability on Sept. 6, 2017. The guidance offers insight into what the agency is looking for in terms of safety and effectiveness for..

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29 Dec, 17

FDA Recommendations For Medical Device Cybersecurity

posted in cybersecurity, medical device by Kapstone Medical

The topic of cybersecurity for medical devices became a hotter issue this past year amid several high-profile hospital cybersecurity breaches, and the FDA is paying close attention.

In a blog post..

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22 Nov, 17

3D printed Robot Fits Inside MRI For More Accurate Breast Biopsy

posted in 3D Printing, medical device by MedTech Momentum

Stormram 4 sounds like the latest video game from Xbox, instead it is a unique robot made from 3D printed plastic that may provide an unprecedented level of accuracy in doing breast cancer..

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28 Aug, 17

FDA Exempts More Than 1000 Medical Devices from 510(k)

posted in FDA 510(k), medical device by MedTech Momentum

FDA exempts more than 1000 devices from 510(k) premarket submissions.

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10 Aug, 17

What You Missed Last Month (April Edition)

posted in 3D Printing, medical device, Monthly Round-Up by MedTech Momentum


The month of April was another busy one, especially in the Medical Device industry! April was jam packed with news about the latest outlook of the medical design and manufacturing fields, the..

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26 May, 17

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