Group items tagged

Radiofrequency ablation is a relatively new method of reducing pain associated with back pain. In a recent review published by an organization that studies medical innovations, the Global Commission on Systemic Palliative Care (GCSPC) stated that the most common application for radiofrequency ablation is the treatment of pain in the spine, which has been used since the 1970s. There are many other applications, although these are two examples of the typical type of pain that this device is used to relieve. Rising prevalence of cancer is expected to drive growth of the global radiofrequency ablation device market during the forecast period. The number of cancer cases has increased over the years globally. According to the World Health Organization (WHO), in 2018, around 18.1 million new cases of cancer and 9.6 million deaths due to cancer were reported globally. According to the same source, around 70% of deaths from cancer occur in emerging economies with lung cancer accounting for the majority of deaths followed by breast cancer. Furthermore, according to the National Cancer Institute, in 2020, around 1,806,590 new cases of cancer are expected to be diagnosed in the U.S. with over 600,000 people dying from this disease. Such high incidence of cancer has led to increased demand for radiofrequency ablation devices. Hence, these factors are expected to drive growth global radiofrequency ablation device market during the forecast period. Furthermore, rising prevalence of cardiovascular disease combined with increasing number of ablation procedures is expected to boost the global radiofrequency ablation device market growth over the forecast period. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/radiofrequency-ablation-device-market.html

Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

Autoclaves are also known as steam sterilizers and are used to expose each item to direct steam contact at the required temperature and pressure for the specified time. They are used for healthcare or industrial applications to eliminate the protein structure of the bacteria and spores. Compatible of steam autoclaves for crisis strategy decontamination of N95 respirators is expected to propel growth of the global steam autoclave market. For instance, in October 2020, 3M, a U.S-based multinational conglomerate corporation, announced that Belimed steam autoclaves are compatible for crisis strategy decontamination of specific single-use N95 Respirators. Moreover, launch of biological indicators for steam autoclaves is also expected to aid in growth of the market. For instance, in December 2020, Steris Corporation, a U.S-based medical equipment company, launched Spordex Self-Contained Biological Indicator Ampoules to confirm sterilization of liquids in steam autoclave cycles. Emergence of Covid-19 is expected to offer lucrative growth opportunities for players in the global steam autoclave market. For instance, globally, as of 4:03pm CET, 1 March 2021, there have been 113,820,168 confirmed cases of COVID-19, including 2,527,891 deaths, reported to the World Health Organization. Moreover, high prevalence of hospital-acquired infections is also expected to aid in growth of the market. For instance, according to an observational epidemiological study of intra-abdominal infections published in December 2019, in NEJM Journal Watch, of the 2621 critically ill adults with intra-abdominal infections at 309 international centers between January and December 2016, 32% were community-acquired, while 68% were hospital-acquired. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/emergence-of-covid-19-and-lunch-of-new.html

Endoscopy is a procedure that has been developed to assist in the removal of endometriosis from the human body. Endoscopy is also being used to help in the treatment of gallstones, cholecystitis, and gastric reflux disease among a number of other conditions. The recent developments in this industry have been driven by changes in government regulation and legislation. The increase in the number of malignancies and the introduction of fiscal policy in the region has resulted in political will on the part of the governments to strengthen public health services. Rising product approval for endoscopy devices by regulatory authorities is expected to drive growth of the global endoscopic stricture management device market during the forecast period. For instance, in January 2020, Pentax Medical received the U.S. Food and Drug Administration (FDA) approval for its Imagina Endoscopy System, which will be used in performing gastrointestinal procedures, digital image enhancement system with Pentax i-Scan. This endoscopy machine is equipped with an LED touch-screen interface, which removes the need for periodic bulb replacement. Besides, it is far more cost-efficient than the GI endoscopy system such as video endoscopy. Thus. These factors are expected to drive growth of the global endoscopic stricture management device market during the forecast period. Furthermore, increasing incidence of bleeding during surgical procedures combined with growing number of endoscopic procedures is expected to boost the global endoscopic stricture management device market growth over the forecast period. However, the lack of skilled healthcare professionals to perform surgical procedures, especially in emerging economies combined with complications related to endoscopic procedures such as bleeding and infection is expected to hamper the global endoscopic stricture management device market growth over the forecast period. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/end

2-day In-person Seminar Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing Overview: The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary, from a risk management perspective Agenda Day One Lecture 1: Regulatory Requirements Lecture 2: Vocabulary and Concepts Lecture 3: Confidence Intervals (attribute and variables data) Lecture 4: Normality Tests and Normality Transformations Lecture 5: Statistical Process Control (with focus on XbarR charts) Lecture 6: Confidence/Reliability calculations for Proportions Lecture 7: Confidence/Reliability calculations for Normally distributed data (K-tables) Lecture 8: Process Capability Indices calculations(Cp, Cpk, Pp, Ppk) Day Two Lecture 1: Confidence/Reliability calculations using Reliability Plotting (e.g., for non-normal data and/or censored studies) Lecture 2: Confidence/Reliability calculations for MTTF and MTBF (this typically applies only to electronic equipment) Lecture 3: Statistical Significance: t-Tests and related "power" estimations Lecture 4: Statistical Significance: ANOVA calculations Lecture 5: Metrology (Gage R&R, Correlation, Linearity, Bias , and Uncertainty Budgets) Lecture 6: QC Sampling Plans (C=0 and Z1.4 attribute AQL plans, and alternatives to such plans) Lecture 7: Statistically valid statements for use in reports Lecture 8: Summary and Impleme

Epilepsy also referred to as a seizure disorder in which nerve cell activity in the brain is disturbed causing seizures. Over 50 million cases of epilepsy are observed across the globe with 80% of them living in emerging economies. Generally, epilepsy is treated by medication, while some cases require surgery, devices, or dietary changes. Over the years, various antiepileptic drugs have been approved and introduced in the market. Each new antiepileptic medication is well tolerated and shows statistically significant improvements in seizure frequency over time compared to pretreatment. However, these medications each carry their own set of challenges and limitations that must be addressed to patients taking them. Carbamazepine, a member of the benzodiazepine class, is antiepileptic drugs used to treat patients with symptomatic epilepsy and other forms of non-epilepsy epilepsy. It is typically administered intravenously or intramuscularly. Patients must be carefully monitored for allergic reactions and heart and blood pressure effects. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/antiepileptic-drugs-are-getting-better.html

Kidney stones, also known as renal calculi, occur when the liquid stored in the kidneys becomes too concentrated. The stone, once lodged in the urinary tract, obstructs the urine flow from it and causes great pain in the abdomen. Other symptoms of a kidney stone include a burning sensation or an intense desire to urinate frequently. Also experiencing frequent urge to pass urine. Kidney stones can be treated effectively, due to presence of advanced methods and associated medical devices. Kidney stone management devices are widely used to retrieve kidney stones. Increasing prevalence of kidney stones and the increasing preference for minimally invasive surgeries worldwide is expected to propel the growth of the kidney stone management devices market. For instance, according to the United States National Kidney Foundation, every year, more than half a million people go to emergency rooms for kidney stone problems. It is estimated that one in ten people will have a kidney stone at some time in their lives. Moreover, increasing product launches, technological advancements, and increasing research and development activities for the prevention and treatment of kidney stones is expected to augment the growth of the kidney stone management devices market. For instance, in August 2020, Dornier MedTech (Dornier) announced the launch of UroX, a community that connects professionals from various disciplines to cultivate innovation and solve the most pressing challenges in urology. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/increasing-prevalence-of-kidney-stones.html

The factors such as rise inpreference for minimally invasive surgeries and increase inprevalence of peripheral & coronary heart diseases are expectedto boost the growth of the atherectomy device market in thecoming years. Furthermore, favorable medical reimbursement scenario from the government is anticipated to propel theatherectomy devicemarket growth. However, lack of skilled professionals and stringent regulatory scenario is expected to restrain the market growth.

Basics of the Anti-Kickback Statute : The Anti-Kickback Statute is aimed at curbing abuse and fraud in the Medicare and Medicaid systems by professionals who offer services and benefit in direct or indirect ways. In order to protect Medicare and Medicaid patients, as well as federal health care programs from abuse and fraud; the Anti-Kickback Statute was enacted. The core act that the Anti-Kickback Statute considered as fraud and abuse is the unlawful acceptance or diversion of money into influencing medical decision-making. The Anti-Kickback Statute is very clear on this. It states that anyone in the healthcare industry, who consciously and deliberately accepts a fee or remuneration of any kind or offers the same with the intention of manipulating the course of a medical decision-making, is liable to punishment. What acts attract penalties? Acts of various kinds attract penalties under the Anti-Kickback Statute. Some of these include: Carrying out advertising or marketing activities for promoting the brand of health care providers Participating in affiliate programs or pay per click commissions Working out promotion agreements with multiple companies Taking part in sponsorships Working out strategic alliances with healthcare providers Licensing content or technology Selling a healthcare provider's brands of products or services Taking a cut in the advertising revenue The nature of penalties under the Anti-Kickback Statute The Anti-Kickback Statute states major penalties for acts it prohibits. The Anti-Kickback Statute prescribes these major penalties: Up to five years in prison This has the potential to attract additional monetary fines of up to $25,000 Administrative civil money penalties that can go up to $50,000 In addition, the Office of Inspector General (OIG) could initiate administrative proceedings and take steps aimed at prohibiting anyone convicted of an Anti-Kickback violation from participating in State and federal programs. The OIG could also impose

"Booming Medical Tourism in Malaysia"is studied thoroughly on various grounds. Comprehensive study of the current market scenario along with the existing medical infrastructure covering hospitals, healthcare human resources and technological developments has been done.

Tissue Transplantation products and services are getting widely used in the healthcare sectors worldwide. The term Tissue Transplant refers to the process of adding new tissues to the body that is broken down and replaced by other organs or tissues. It is a major breakthrough in organ transplantation and is used more frequently. Tissue Transplantation is the practice of harvesting and replacing human organs such as kidneys, liver, heart valves, lungs, and bones with other healthy tissues from other people. Tissue Transplantation has given hope to many patients who have had to have a hip replaced or a kidney removed because of disease or illness. In recent years, there has been an increase in the number of people who are now choosing to donate their organs and tissues to medical research and treatment centers. More people are now aware of the need for organ donations and more people are now looking to give back to society than ever before. The demand for organ and tissue transplantation is increasing every day. Unhealthy food habits lack of exercise, drug abuse, and alcohol consumption results in organ failure, owing to which the demand for the Tissue Transplantation products and services market is estimated to rise. Increasing events of acute diseases are also estimated to aid the growth of the market. For instance, high blood pressure and diabetes are the main causes of end-stage renal diseases where kidney dialysis or transplant are the only options to save the patients. According to the U.S. Department of Health & Human Services, in 2019, there were approximately 122,913 patients in U.S. who needed urgent tissue transplants. Hence the increasing demand for advanced transplantation products is estimated to drive the market growth. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/the-global-tissue-transplantation.html

The patient registry software market is expected to witness a significant growth over the next five years. The reason for this is the ever-expanding focus on healthcare delivery, particularly in the non-clinical fields of patient care, education, prevention and public health. Patient safety is being continuously refined with the advent of new devices and applications in the clinical laboratories. Certain drivers are also behind the patient registry growth. These include adoption of EHR, creation of patient registries to track patient records, and greater use of electronic medical records (EMR) for post-marketing management. Increasing prevalence of cancer and other chronic disorders is expected to propel growth of the global patient registry software market. For instance, according to the study, "Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition", published in the journal Diabetes Research and Clinical Practice, in September 2019, 463 million people are expected to suffer from diabetes in 2019 worldwide and the number is expected to reach 578 million by 2030 and 700 million by 2045. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/increasing-prevalence-of-cancer-and.html

The orthopedic biomaterials market has undergone a shift away from certain devices and towards new areas and medical devices.

Surgical drain cleaning equipment plays an integral part in ensuring maximum productivity in the healthcare industry. These devices are meant to evacuate fluid and prevent the buildup of air at the surgical site. This is done with the use of vacuum or wall suction. Majority of these devices use negative pressure therapy to drain fluid from the surgical site. Demand for such medical devices has increased at a rapid pace due to their various advantages which make them highly useful. Increasing prevalence of chronic diseases such as cancer, cardiovascular disease, and kidney disease is expected to drive growth of the global surgical drainage devices market during the forecast period. According to the World Health Organization (WHO), in 2018, around 9.6 million deaths were attributed to cancer across the globe. According to the same source, around 70% of deaths from cancer occur in emerging economies. Moreover, according to the WHO, around 17.9 million people die from cardiovascular diseases each year globally. According to the same source, in 2010, around 2.3-3.7 million people were suffering from end-stage kidney disease. These above-mentioned diseases require significant surgical procedures and hence, it is boosting the demand for surgical drainage devices. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/surgical-drainage-devices-market-is.html