Blogs

3D-printed device could treat spinal cord injuries

posted in 3D Printing, medical devices, spinal cord injuries by Kapstone Medical

The dream is to eventually 3D print a spinal cord scaffold layered with viable neurons that can be implanted into a human spinal cord and rebuild damaged neural connections and restore mobility to..

Read More
05 Nov, 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.

Read More
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..

Read More
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..

Read More
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..

Read More
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..

Read More
18 Oct, 18

$10 chip changes standard ultrasound into 3D

posted in chip, ultrasound, 3D by Kapstone Medical

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..

Read More
03 Oct, 18

What You Missed Last Month – August 2018

posted in 3D Printing, medical devices by Kapstone Medical

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..

Read More
28 Sep, 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..

Read More
24 Sep, 18

Leveraging 3D Printing For Small Hospitals and Device Developers

posted in 3d printing blogs, medical devices, Additive Manufacturing by Kapstone Medical

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.

Read More
13 Sep, 18

latest comments

Like Us on Facebook

Recent Tweets