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

November 13, 2019 / by Kapstone Medical / 4 minute read

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 with enforcement set to begin in May 2020.

The new regulation repeals and replaces the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD), effectively pushing the reset button for medical device makers who sell products in Europe.

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What You Missed Last Month – January Edition

February 4, 2019 / by Kapstone Medical / 1 minute read

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 to approve 3D medical devices. Here is a quick overview of what you missed:

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What You Missed Last Month – December Edition

January 31, 2019 / by Kapstone Medical / 1 minute read

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 December. Here is a quick overview of what you missed:

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What You Missed Last Month – November Edition

December 29, 2018 / by Kapstone Medical / 2 minute read

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 model body parts, a lot went on in the month of November. Here is a quick overview of what you missed:

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

December 26, 2018 / by Kapstone Medical / 1 minute read

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's ASCA Pilot Program

December 20, 2018 / by Kapstone Medical / 1 minute read

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 program for medical device conformity assessment accreditation, known as the Accreditation Scheme for Conformity Assessment, or ASCA.

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BioLIFE4D Has Successfully 3D Printed Human Cardiac Tissue

December 11, 2018 / by Kapstone Medical / 2 minute read

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, 3D Printed to Order

December 7, 2018 / by Kapstone Medical / 2 minute read

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

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

November 28, 2018 / by Kapstone Medical / 1 minute read

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 based medical devices, there was a lot of exciting events that occurred in October.

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Researchers 3D-print light receptor array on a curved surface

November 20, 2018 / by Kapstone Medical / 2 minute read

Achievement advances quest for bionic eye prototype

The act of “seeing” is the result of a complex system of biological tissues that capture and focus light onto an array of photosensitive receptors in the retina that converts light into electrical signals and sends them to the brain through the optical nerve.

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