European MDR: How do we get ready for MDR?

Second in a 7-part series on the EU’s Medical Device Regulation

The new Medical Devices Regulation (2017/745/EU), or more commonly referred to as the EU MDR, poses significant challenges to...

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What is European MDR and Why It happened, Timelines for Compliance

First in a 7-part series on the EU’s Medical Device Regulation

The European Parliament passed the Medical Device Regulation (MDR) two years ago and began a three-year transition period in May 2017...

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kapstone-ai-what-you-missed

What You Missed Last Month – January Edition

Artificial Intelligence and 3D Printing are making history in the medical device world. From AI manufacturing machines to the creation of 3D printed organs to more streamlined processes by the FDA...

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kapstone what you missed december AI

What You Missed Last Month – December Edition

From 3D printed light receptors for prosthetic vision devices to $10 3D ultrasound chips and 3D printing for spinal cord injuries to 3D printed model body parts, a lot went on in the month of...

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What you missed november 2018

What You Missed Last Month – November Edition

Lots went on in the 3D Printing field last month. From 3D printed light receptors for prosthetic vision devices to $10 3D ultrasound chips and 3D printing for spinal cord injuries to 3D printed...

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glucose monitoring system

FDA Approves First Continuous Glucose Monitoring System Not Requiring Blood Sample Calibration

The FDA approved last July the first continuous glucose monitoring system that could free millions of people with diabetes from daily finger sticks.

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fda

FDA's ASCA Pilot Program

Agency publishes details for conformity assessment

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published additional information on its pilot...

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biolife-4d-heart-implant

BioLIFE4D Has Successfully 3D Printed Human Cardiac Tissue

BIOLIFE4D announced earlier this year that it has successfully 3D printed human cardiac tissue demonstrating the ability to 3D bio-print viable tissue for transplant.

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heart-implant-kapstone-medical

Heart Implant, 3D Printed to Order

For patients with heart rhythm disorders, current pacemakers and implantable cardioverter defibrillators are “one-size-fits- all” devices that provide narrowly limited information for...

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kapstone medical 3d printing

What You Missed Last Month - October (3D Printing)

The MedTech Industry has been very busy with 3D printing! From the first 3D printed human corneas and custom cardiac surgical devices to 3D printing helping in the development of mobile phone...

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