Playbook sets framework for dealing with medical device cybersecurity attacks

October 18, 2018 / by Kapstone Medical posted in cybersecurity, FDA, medical device

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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.

NSF International offers online learning for MDSAP program

July 27, 2018 / by Kapstone Medical posted in 510(k), medical device, Quality

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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 device industry in the five countries participating in Medical Device Single Audit Program (MDSAP).

ACA tax has $665 million impact on medical device industry

July 24, 2018 / by Kapstone Medical posted in medical device, tax, ACA, Affordable Care Act

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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 researcher.

FDA Reconfirms Continued Acceptance of Single Audits

February 9, 2018 / by Kapstone Medical posted in FDA, medical device

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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 Program (MDSAP) for medical device regulatory approval.

What You Missed With the New Year Tax Reform

January 17, 2018 / by Kapstone Medical posted in medical device, tax reform, tax

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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 industry was left scratching its collective head and asking what happened to the medical device excise tax repeal?

FDA’s Advice for Medical Device Interoperability

December 29, 2017 / by Kapstone Medical posted in medical device

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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 medical devices that are connected to each other and to other technology.

FDA Recommendations For Medical Device Cybersecurity

November 22, 2017 / by Kapstone Medical posted in cybersecurity, medical device

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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 on the FDA’s site, Suzanne B. Schwartz, the FDA’s Associate Director for Science and Strategic Partnerships at the Center for Devices and Radiological Health, she outlined the FDA’s approach to medical device cyber safety.

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

August 28, 2017 / by MedTech Momentum posted in 3D Printing, medical device

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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 biopsies.

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

August 10, 2017 / by MedTech Momentum posted in FDA 510(k), medical device

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

What You Missed Last Month (April Edition)

May 26, 2017 / by MedTech Momentum posted in 3D Printing, medical device, Monthly Round-Up

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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 advancements of 3D printing technology in surgical training, and the key risks in product development. So, in case you missed it, here are a few highlights of medical device news from April. 

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