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Medical Receives Fda Breakthrough Device Designation Articles & Analysis

12 articles found

Innovations in Marker Band Technology for Advanced Medical Applications

Innovations in Marker Band Technology for Advanced Medical Applications

Marker bands have become indispensable in modern medicine, playing a crucial role in medical imaging and minimally invasive procedures. They act as significant indicators during real-time imaging, helping surgeons and radiologists achieve exceptional precision. With the increasing demand for precision and safety in medical instruments, innovations in marker band technology have pushed the ...

ByEdgetech Industries LLC


Marker Bands in Medical Imaging and Interventional Procedures

Marker Bands in Medical Imaging and Interventional Procedures

Marker bands serve a critical function in medical imaging and interventional procedures, offering Marker bands are essential for precise visualization during medical treatments. Designed for visibility under fluoroscopic imaging, these radiopaque bands, made from materials like platinum-iridium alloy, gold, and tantalum, play a critical role in healthcare applications. They enhance accuracy in ...

ByEdgetech Industries LLC


Navigating the Crucial Path of Medical Device Validation and Verification

Navigating the Crucial Path of Medical Device Validation and Verification

Introduction In the rapidly evolving healthcare landscape, medical devices play a pivotal role in enhancing patient care and improving health outcomes. The road to getting these devices from concept to patient use is filled with meticulous checks to ensure safety, efficacy, and compliance with regulatory standards. Central to this journey is the process of validation and verification (V&V), ...

ByProtheragen-ING


How Proper Packaging Improves the Shelf Life of Medical Devices

How Proper Packaging Improves the Shelf Life of Medical Devices

Medical devices are incredibly important in today’s world. They play a significant role in the treatment and prevention of various medical conditions. However, their effectiveness can be compromised if they are not packaged correctly. Packaging is an essential component of maintaining the integrity and shelf life of medical devices, especially during transportation and storage. Read on ...

ByPlastic Ingenuity


To patent or not to patent…pragmatic thoughts for surgeons

To patent or not to patent…pragmatic thoughts for surgeons

Many surgeons get great ideas about new medical devices as they solve problems in healthcare. JUNE MEDICAL Founder and Owner Angela Spang have been advising surgeons, entrepreneurs and business owners on device strategy for a long time, and have summarised her thoughts on the great question on IF AND WHEN TO PATENT the innovation. Here is a short overview: Decide if You Need a Patent Decide ...

ByJUNE Medical USA Inc


Meet the Entrepreneur: Carolyn Yarina and Gillian Henker, Sisu Global

Meet the Entrepreneur: Carolyn Yarina and Gillian Henker, Sisu Global

At FINCA Ventures, we look for entrepreneurs leveraging market-based solutions to create large-scale, lasting social impact. In this series, “Meet the Entrepreneur,” we’ll be taking you into the minds of the intrepid leaders at our portfolio companies who boldly venture into markets in need of positive disruption. Globally, there is a shortage of over 100M units of donor blood ...

BySisu Global Health


We put the O2 in WRKUT

We put the O2 in WRKUT

Over the course of time, humankind has been continuously searching for methods to remain young, preserve their health and become more and more efficient in all aspects of their existence. Especially nowadays, in the fast-paced world that we all live in, it is important to maintain a balanced lifestyle and to prioritize the health of our bodies and minds. But do you really have the time to ...

ByOXYHELP INDUSTRY


Common Mistakes in Measuring Medical Optics and How to Avoid Them

Common Mistakes in Measuring Medical Optics and How to Avoid Them

Optics and medical devices have a long history and partnership. Since the invention of the microscope in the late 1500s to mid-1600s, the interest and desire to “see” into the human body to diagnose illness and subsequently repair it has only intensified. Optics in modern medical devices fall into two categories: those used for diagnosis of illness, and those which are therapeutic or ...

ByZygo Corporation - AMETEK, Inc


Needlestick Injury - the pointy end of a preventable pandemic

Needlestick Injury - the pointy end of a preventable pandemic

The Challenge Every 60 minutes, of every day, six people suffer a needlestick injury somewhere in the world. Every day, 3 people die as a result of those injuries[1]. The World Health Organisation (WHO) reports in the World Health Report 2002, that of the 35 million health-care workers world wide, two million experience percutaneous exposure to infectious diseases each year[2]. WHO estimates ...

ByNumedico Technologies Pty Ltd


4 factors that make a nasal aspirator safe

4 factors that make a nasal aspirator safe

Do you remember the moment when you found that you have to clear your baby’s nose? You probably thought it was a joke and you didn’t want to believe it. “A nasal aspirator? What else will they come up with… Do I really need it? Is that even safe?!” Most parents share your doubts at first. However, these uncertainties disappear once you find out how much relief a ...

ByNosiboo


Humidity’s Impact on Medical Devices

Humidity’s Impact on Medical Devices

When hearing terms like humidity and relative humidity, people often think about the weather. This is because water vapor has an impact on how humans perceive comfort; both high humidity and low humidity can make people feel uncomfortable. You might already be aware that amount of water vapor present in air can impact how a medical device performs. Understanding how water vapor affects analysis ...

ByPerma Pure LLC - a Halma Company


Humidity’s Impact on Medical Devices, Part One

Humidity’s Impact on Medical Devices, Part One

When hearing terms like humidity and relative humidity, people often think about the weather. This is because water vapor has an impact on how humans perceive comfort; both high humidity and low humidity can make people feel uncomfortable. You might already be aware that amount of water vapor present in air can impact how a medical device performs. Understanding how water vapor affects analysis ...

ByPerma Pure LLC - a Halma Company

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