Playbook sets framework for dealing with medical device cybersecurity attacks

October 18, 2018 / by Kapstone Medical / 2 minute read

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.

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NSF International offers online learning for MDSAP program

July 27, 2018 / by Kapstone Medical / 1 minute read

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).

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ACA tax has $665 million impact on medical device industry

July 24, 2018 / by Kapstone Medical / 2 minute read

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.

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FDA Reconfirms Continued Acceptance of Single Audits

February 9, 2018 / by Kapstone Medical / 1 minute read

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.

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What You Missed With the New Year Tax Reform

January 17, 2018 / by Kapstone Medical / 2 minute read

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?

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FDA’s Advice for Medical Device Interoperability

December 29, 2017 / by Kapstone Medical / 2 minute read

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.

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FDA Recommendations For Medical Device Cybersecurity

November 22, 2017 / by Kapstone Medical / 2 minute read

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.

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

August 28, 2017 / by MedTech Momentum / 2 minute read

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.

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

August 10, 2017 / by MedTech Momentum / 2 minute read

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

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What You Missed Last Month (April Edition)

May 26, 2017 / by MedTech Momentum / 1 minute read

 

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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What You Missed Last Month (March Edition)

April 26, 2017 / by MedTech Momentum / 1 minute read

The month of March has come and gone in what seems like the blink of an eye! U.S. Senate bills on FDA inspections were filed, regulations were proposed for the medical device industry, and research was conducted on the effects of 3D printing on the pharma and medical device markets. So, in case you missed it, here is a quick recap of what you might have missed in the Medical Device Industry last month.

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MedTech in the US Healthcare Industry

March 28, 2017 / by MedTech Momentum / 2 minute read

Will 2017 be a good year for MedTech in the US Healthcare Industry? Signs point to yes.

Looking at the uncertain healthcare landscape under the new Trump administration, predicting future healthcare markets seems like an exercise in magic 8-ball prediction. You know the toy that answers any yes or no question with some ambiguous answer like, “Luck is on your side.”

Bloomberg reported that in a conference call, AstraZeneca Plc CEO Pascal Soriot pointing to the daily uncertainty over repeal and replacement of the ACA, financing care, and in rule setting for everything from how hospitals operate to which drugs can be sold said, “You really cannot predict the unpredictable.”

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What You Missed Last Month (February 2017 Edition)

March 15, 2017 / by MedTech Momentum / 1 minute read

February was a busy month for the MedTech world. From the FDA approval of a 3D printed cranial implant to the evolution of the Medical Device Industry in 2017, here is a quick recap of what you missed last month in the Medical Device Industry in February:

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What You Missed Last Month (January 2017 Edition)

February 6, 2017 / by MedTech Momentum / 1 minute read

Stay up to date with the latest medical device manufacturing news. Here’s a recap while you were getting a start on the New Year with some of the top stories in the manufacturing and the MedTech world. Here’s what you missed last month:

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What You Missed Last Month (October 2015 – Medical Devices & 3D Printing)

November 13, 2015 / by Kapstone Medical / 2 minute read

Happy November! Fall is finally here, and with the cascading leaves also descends a plethora of exciting developments emanating from the world of Medical Devices and 3D Printing!

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What You Missed Last Month (September 2015 Edition –Medical Device & 3D Printing)

October 22, 2015 / by MedTech Momentum / 2 minute read

As summer drew to a close and the leaves began to turn to vivid shades of orange, red, and yellow, Team Kapstone was busy exploring the most educational and inspirational stories in 3D printing, medical device, and orthopedics. We are proud to provide our season-changing September “What You Missed” articles that inspired, equipped, and guided us through the end of summer and the advent of autumn:

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What You Missed Last Month (August 2015 Edition –Medical Device & 3D Printing)

September 16, 2015 / by Kapstone Medical / 1 minute read

It’s back to school with Team Kapstone! In August, we picked up educational and inspirational stories in 3D printing, medical device, and orthopedics. Here’s your August “What You Missed” reading list - three articles to Inspire, Equip, and Guide you through the last month:

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What You Missed Last Month (July 2015 Edition –Medical Device & 3D Printing)

August 12, 2015 / by Kapstone Medical / 2 minute read

While you were enjoying your summer vacation, Team Kapstone compiled some of the best stories in 3D printing, medical devices, and orthopedics. Catch back up with three articles to Inspire, Equip, and Guide you through what you missed in July:

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