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New device, CGMS, launched first time in TN for diabetes
control A new medical technology which is expected to
benefit 60 lakh diabetic patients in Tamil Nadu has been launched in a Scan
Centre in Chennai.
The state-of-the-art technology is known as Continuous
Glucose Monitoring Systems [CGMS], whose 4th generation device, iPro2, is now
available in all the five branches of the scan centre for monitoring diabetes.
A study conducted by specialized medical institutions on
diabetic research says that there are over sixty lakh people in the state
affected with diabetes which is expected to increase by 170 per cent by 2025.
The most modern device with CGM Systems helps a diabetic patient to understand
how his/her blood sugar is changing throughout the day.
According to experts in the field, blood sugar (blood
glucose) of a diabetic patient changes every minute of the day causing
complications like blindness, heart attack, kidney failure, paralysis and leg
amputation. While treating the disease, it is critical to keep the patient’s
blood sugar as close to the normal range as possible at all times. The latest
CGMS is an answer to this problem, said the doctors in the Aarthi Scans which
has introduced the technology first time in Tamil Nadu.
Dr J S Kumar, Diabetology-in-charge, SRM Medical College,
Chennai, who is using the device in the scan centre for his patients said the
device is used in more than 49 countries to detect variations of blood sugar
every 5 minutes for diabetes management.
According to him, a CGMS can help a diabetic patient to
become aware of his/her glucose levels and how they change based on food,
exercise, and medication as the device shows sugar readings every 5 minutes.
Almost 300 such readings will be recorded in a day while patient is doing
routine activities like office work, exercise, travelling, swimming, sleeping
etc. The test is extremely useful for diabetic patients planning pregnancy.
Further, the test will help patients feel more confident about the way they are
managing their diabetes.
The doctors in the scan centre claim that the 4th generation
iPro 2 Professional CGM system is valuable for detecting high and low glucose
fluctuations that can lead to dangerous health complications, which often go
undetected with traditional tests.
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Breaking Into
Major Markets for Medical Device Manufacturers
The global demand for medical devices has been steady in
traditional markets despite the economic downturn and even increasing in some
emerging markets. For medical device manufacturers seeking access to new
markets, conformity with regulatory requirements is most often a prerequisite.
Those who want to compete effectively should also have in place a properly
implemented and maintained quality management system.
Many manufacturers are discovering the benefits of working
with a registrar because their experience and know-how provides a single source
for certification to international standards and conformity assessments to
medical device directives.
The benefits of management systems certification
For example, your management system’s conformity with ISO
13485-“Medical devices-Quality management systems-Requirements for regulatory
purposes,” from the International Organization for Standardization (ISO) can
help you open the door to untapped domestic and international business
opportunities, and reap the benefits of:
Expanded market access. National regulatory
authorities require or strongly prefer that manufacturers marketing medical
products in their countries have a third-party audited and certified management
system in place. Investing in such a system speeds access into those countries
that require it, and expedites market entry into the others.
Reduced cost of sales. Your certification establishes
your company’s credibility and commitment to quality. Because the task of
explaining the specifics and demonstrating the effectiveness of your quality
system is more straightforward, it takes less time to earn your prospective
customers’ trust and confidence.
Improved performance. Based on a uniform and widely
accepted system of process control, your certified management system helps you
improve your products and processes. This can foster improved relationships with
your suppliers, business partners, and customers, and give you a real advantage
in the marketplace.
While the process of breaking into a new market may seem
confusing and at times a bit overwhelming, it can actually be broken down into
five steps:
-
Determine if your
product meets the definition of a medical device.
-
Classify your
device.
-
Prepare technical
documentation, and develop and implement your quality management system.
-
Fulfill premarket
requirements and apply for assessment by a regulatory authority/conformity
assessment body.
-
Maintain your
quality management system and perform post-market surveillance activities.
The easy-to-use quick guide below summarizes the device
classification, technical documentation, and quality systems requirements for
medical device manufacturers in four of the world’s largest markets: the United
States, the European Union, Japan, and Canada.
http://www.qualitydigest.com/inside/health-care-article/breaking-major-markets-medical-device-manufacturers.html |
