#Medical Devices Report

[iziel-healthcare]

What is Difference between PMS and PMCF?

Understanding PMS

Post-Market Surveillance (PMS) is the systematic process of monitoring the safety and performance of a medical device after it has been placed on the market.

It involves collecting, analyzing, and interpreting data to ensure the continued safety and effectiveness of the device.

PMS is essential for identifying and addressing any potential risks or issues that may arise once the device is in widespread use.

Exploring PMCF

Post-Market Clinical Follow-up (PMCF) is a specific type of post-market surveillance that focuses on the clinical performance of a medical device.

It involves conducting clinical studies or gathering clinical data to assess the device's safety and performance in real-world settings.

PMCF is particularly important for high-risk devices or those with long-term implantation to ensure ongoing patient safety.

Differentiating PMS and PMCF

PMS is a broader term that encompasses all post-market surveillance activities, including PMCF.

PMCF is a more targeted approach that specifically looks at the clinical aspects of a device's performance.

While both PMS and PMCF aim to monitor device safety and performance, PMCF typically involves more rigorous clinical data collection and analysis.

Conclusion

In summary, PMS and PMCF are both crucial components of ensuring the ongoing safety and effectiveness of medical devices.

While PMS provides a general oversight of device performance, PMCF homes in on the clinical aspects to ensure patient safety.

  By understanding the differences between PMS and PMCF, manufacturers can implement comprehensive post-market surveillance strategies to meet regulatory requirements and protect patient health.

[naritaren]

I'm calmed down now, but the cunt at the entrance really pissed me off. She made me literally dump out my entire bag full of medical stuff because it kept setting off the fucking metal detector. She could see in my fuckin bag that there were no weapons and almost didn't let me in.

It took one of the actual staff to step in because at one point I went "you are really making a disabled person show off every medical thing in their bag"

And they apologized and gave me a number to call because it was fucking excessive.

Like I keep my bag so that you can see everything in it when it's opened so they can check it. This cunt made me take everything out of the bag to run it through the fucking machine.

[swapnamakro]

What are the most important steps for a successful EU IVDR clinical evaluation?

When it comes to a successful EU IVDR clinical evaluation, there are several crucial steps to follow:

Define Clear Objectives: Start by outlining the specific goals of your clinical evaluation, aligning them with the requirements of the EU IVDR.

Comprehensive Data Collection: Gather all relevant clinical data, including pre-existing data and new studies, ensuring that they meet the necessary standards.

Thorough Data Analysis: Analyze the collected data rigorously to demonstrate the safety, performance, and benefits of the device.

Continuous Documentation: Maintain detailed and up-to-date documentation throughout the evaluation process.

Expert Review and Validation: Have your evaluation reviewed by qualified experts to validate your findings and ensure compliance.

By following these steps, you can achieve a robust and compliant clinical evaluation under the EU IVDR.

For more info:

https://www.makrocare.com/blog/eu-ivdr-performance-evaluation-in-8-steps/

[tritonmarketresearchamey]

Surgical Masks Market: Post-COVID Prospects

Short-term demand for surgical masks remains unprecedented; however, growing awareness regarding their effectiveness will lead to steady sales in the long term. Our study estimates the global surgical masks market to surge at a CAGR of 10.2% during the forecast period 2022-2028. This growth is fueled by the growing awareness of healthcare-associated infections (HAI) and a rise in healthcare expenditure.

According to the World Health Organization (WHO), hundreds of millions of individuals are impacted by healthcare-associated infections (HAIs) annually, resulting in death and financial losses for healthcare systems. Furthermore, factors such as an aging population, the prevalence of chronic and long-term diseases, and increased investments in medical technology & advanced infrastructure will increase healthcare spending globally.

Why is Asia-Pacific a Promising Region in the Surgical Mask Market?

Asia-Pacific is anticipated to be the fastest-growing region in the surgical masks market. The increasing elderly population and growing healthcare infrastructure are likely to boost the demand for healthcare services. Improving hygiene and safety standards leads to increased use of surgical masks, thereby positively impacting the studied market.

Fluid/splash resistant surgical masks leads the product segment in 2021. The growth is associated with the ability of the Splash Resistant technology, which prevents the wearer from droplet infections during any surgical procedure or management of any patients prone to the transmission of the diseases.

On the other hand, India holds a significant prominence in the Asia-Pacific market. The healthcare business in the country is anticipated to expand greatly due to the growing population, increased disposable incomes, improved access to insurance, heightened health awareness, and rising spending by public and private industry participants. In addition, the growing incidence of obesity has led to an increase in chronic ailments, such as heart disease and diabetes, which necessitate various healthcare treatments and services. This is expected to contribute to the expansion of the market for surgical masks.

However, strict government regulations, coupled with the emerging use of substitutes such as N95 masks, are anticipated to hinder the growth of the surgical masks market.

Due to the COVID-19 pandemic, there was a dearth of personal protective equipment, such as surgical masks. This forced the medical staff members performing front-line activities to adopt additional face protection measures, including non-medical masks, simple cloth masks, N95/N99/FFP2/FFP3 respirators, power air-purifying respirators, and face shields/visors, etc.

Technological Integration: The Way Forward

New technology by Ascend Performance Materials is used to manufacture high-efficacy surgical masks to protect against SARS-CoV-2. This technology has shown positive results for deactivating SARS-CoV-2 and other pathogens such as staphylococcus, betacoronavirus OC43, and H1N1. However, it is still awaiting patent and FDA approval. The masks manufactured using this technology combine antiviral protection and superior physical properties meeting the requirements to qualify as Level III under ASTM F2100-19 standards.

In July 2020, Ascend Performance Materials announced the submission of a 510(k) premarket notification to the US FDA for clearance of its surgical mask that uses Acteev technology to offer protection against SARS-CoV-2. Thus, improvements in the manufacturing of reusable non-woven materials, such as antimicrobial fibers and increased comfort, will propel the expansion of the surgical masks market during the forecast period.

 

FAQs

Q1) What are the segments covered in the surgical masks market?

Product, type, material, distribution channel, and end-user are the segments covered in the surgical masks market.

Q2) Who are the key players in the surgical masks market?

The key companies studied in the surgical masks market are 3M, Mediblue Health Care Private Ltd, Cardinal Health, Kimberly-Clark Corporation, Alphaprotech, Ansell Ltd, Magnum Health and Safety Pvt Ltd, and Dupont De Nemours Inc.

[soumyafwr]

https://uchatoo.com/read-blog/9397_network-connected-medical-devices-market-share-overview-competitive-analysis-and.html

Network Connected Medical Devices Market Share, Overview, Competitive Analysis and Forecast 2031

[mitalipingale]

https://tannda.net/read-blog/66449_medical-aesthetic-devices-market-analysis-size-share-and-forecast-2031.html

The Medical Aesthetic Devices Market in 2023 is US$ 15.37 billion, and is expected to reach US$ 32.53 billion by 2031 at a CAGR of 9.82%.

[transcriptioncity]

Clinician Reviewed Medical Translation Services

Clinician Reviewed Medical Translation Services Clinician reviewed medical translation services are crucial for ensuring the accuracy and reliability of medical documents. This specialized review process involves healthcare professionals verifying translations for medical accuracy and contextual relevance. It is used to prevent miscommunication that can lead to serious medical errors. The…

[aimarketresearch]

Wireless Medical Device Connectivity Market Size, Share, Trends, Demand, Future Growth, Challenges and Competitive Analysis

Recent study report released by Data Bridge Market research titled Global Wireless Medical Device Connectivity Market (covering USA, Europe, China, Japan, India, South East Asia and etc) that highlighting opportunities, risk analysis, and leveraged with strategic and tactical decision-making support.

A top notch Wireless Medical Device Connectivity market analysis report contains the recent industry status alongside advanced trends that can impact the actual growth rate of the market. The report gives details of financial outlook, the analysis of the new product, differentiable business strategies as well as revolutionary marketing trends. This market research report deals with bountiful of important market related aspects which are; market size estimations, company and market best practices, entry level strategies, market dynamics, positioning, segmentations, competitive landscaping and benchmarking, opportunity analysis, economic forecasting, industry-specific technology solutions, roadmap analysis, and in-depth benchmarking of vendor offerings.

Access Full 350 Pages PDF Report @

Data Bridge Market Research analyses that the wireless medical device connectivity market which was USD 1.73 billion in 2021, would rocket up to USD 9.80 billion by 2029, and is expected to undergo a CAGR of 24.21% during the forecast period 2022 to 2029. In addition to the market insights such as market value, growth rate, market segments, geographical coverage, market players, and market scenario, the market report curated by the Data Bridge Market Research team also includes in-depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Key points covered in the report: -

The pivotal aspect considered in the global Wireless Medical Device Connectivity Market report consists of the major competitors functioning in the global market.

The report includes profiles of companies with prominent positions in the global market.

The sales, corporate strategies and technical capabilities of key manufacturers are also mentioned in the report.

The driving factors for the growth of the global Wireless Medical Device Connectivity Market are thoroughly explained along with in-depth descriptions of the industry end users.

The report also elucidates important application segments of the global market to readers/users.

This report performs a SWOT analysis of the market. In the final section, the report recalls the sentiments and perspectives of industry-prepared and trained experts.

The experts also evaluate the export/import policies that might propel the growth of the Global Wireless Medical Device Connectivity Market.

The Global Wireless Medical Device Connectivity Market report provides valuable information for policymakers, investors, stakeholders, service providers, producers, suppliers, and organizations operating in the industry and looking to purchase this research document.

TABLE OF CONTENTS

Part 01: Executive Summary

Part 02: Scope of the Report

Part 03: Research Methodology

Part 04: Market Landscape

Part 05: Pipeline Analysis

Part 06: Market Sizing

Part 07: Five Forces Analysis

Part 08: Market Segmentation

Part 09: Customer Landscape

Part 10: Regional Landscape

Part 11: Decision Framework

Part 12: Drivers and Challenges

Part 13: Market Trends

Part 14: Vendor Landscape

Part 15: Vendor Analysis

Part 16: Appendix

Countries Studied:

North America (Argentina, Brazil, Canada, Chile, Colombia, Mexico, Peru, United States, Rest of Americas)

Europe (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Kingdom, Rest of Europe)

Middle-East and Africa (Egypt, Israel, Qatar, Saudi Arabia, South Africa, United Arab Emirates, Rest of MEA)

Asia-Pacific (Australia, Bangladesh, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Sri Lanka, Thailand, Taiwan, Rest of Asia-Pacific)

Some of the major players operating in the wireless medical device connectivity market are:

Cerner Corporation (U.S.)

Medtronic (Ireland)

Masimo (U.S.)

Koninklijke Philips N.V. (Netherlands)

General Electric (U.S.)

Stryker (U.S.)

iHealth Labs Inc. (U.S.)

Cisco Systems Inc. (U.S.)

Lantronix Inc. (U.S.)

Infosys Limited (India)

Silicon & Software Systems Ltd. (Ireland)

Spectrum Medical (U.K.)

Hill-Rom Services Inc. (U.S.)

Iatric Systems Inc. (U.S.)

Silex Technology America Inc. (Japan)

Digi International Inc. (U.S.)

Baxter (U.S.)

T.E. Connectivity (Switzerland)

Bridge-Tech (U.S)

Medicollector (U.S.)

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About Data Bridge Market Research:

Data Bridge set forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process.

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[iziel-healthcare]

What is Post-Market Clinical Follow-Up?

PMCF study is carried out for CE certified medical devices that are placed in the market. It’s a method of proactive collection of clinical data to analyze the emergent risks/side-effects of the medical device to demonstrate the safety and performance as per the intended purpose, throughout the expected lifetime of the device.

Performance and safety parameters are predefined with acceptance criteria based on the benchmark devices data, and milestones are designed for several PMCF studies and activities. The literature screening and registries study also supports PMCF findings. The sample size is predefined as per the sales of the device to study the emergent risks. Benefit-risk ratio analysis is performed as per the PMCF findings, for the acceptability of the device in the market. The PMCF findings are also documented in Technical Documentation, Risk File, SSCP, CER and PSUR

PMCF Includes

PMCF Procedure

PMCF Plan

PMCF Report

PMCF Plan

PMCF Protocol

Sample Size

Design of Milestones with follow-up period

Design of measurable endpoints for performance and safety

Ethical Committee approval

Questionnaire/Survey form

Patient/subjects consent form

Clinical Investigation/Trial procedure (if any)

Real World Evidence

Statistical Significance 

PMCF Report

Milestones completion

Real World Evidence analysis

Literature Screening

Registries

Questionnaires and Surveys results

Feedback from users/end user

Clinical Investigations/Trials results (if planned any)

Outcome of performance and safety endpoints

Risk benefit analysis

Residual Risks (if any)

Statistical Analysis

CER citation

Frequency of PMCF update

IZiel Healthcare offers PMS services to our clients where we perform end to end Post Market Surveillance activities. These services can be PMS Plan, PMS/PSUR Reports, PMCF Plan and Reports, Trend Reporting, Complaint Handling, Clinical Evaluation, Risk Benefit Management and many more.

We have expertise in designing PMCF Plan and drafting reports for our clients for all the Classes of Medical devices – Class IIa, Class IIb and Class III.

You may contact us at Contact Us – Iziel.

[tamer200333]

Urgent treatment appeal please stop

My sister suffers from advanced fibropulmonary disease, which makes breathing difficult without an oxygen device in light of the lack of electricity and equipment, which makes her suffer from the scourges...

Since her displacement, she left the oxygen machine in her home in the north, and since that day her eyes have not been able to sleep because of the pain she suffers from this dreaded disease.

The least this disease causes

It makes shortness of breath and suffocation ...

I have attached a copy of the report for you. Medical treatment that explains my sister’s condition and suffering

The suffering of living in a tent in the absence of all necessities of life has an impact and other aspects ....

I am attaching a picture of Mesa's children for you

They collect firewood

Firewood is used instead of gas

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Please do not pass the post on without circulating it

[swapnamakro]

What are the essential steps for submitting a Clinical Evaluation Report (CER) for medical devices?

Submitting a Clinical Evaluation Report (CER) is a critical process for medical device organizations, ensuring that their devices meet safety and performance requirements under the European Medical Device Regulation (MDR). A well-prepared CER not only demonstrates compliance but also supports the ongoing marketability of the device.

Here are the essential steps medical device companies should follow when preparing and submitting a CER:

Define the Scope: Clearly outline the device's intended use, clinical benefits, and target population.

Collect Clinical Data: Gather all relevant clinical data, including both pre-market and post-market data, to support the device’s safety and effectiveness.

Conduct a Literature Review: Review existing literature to identify potential risks, benefits, and clinical performance data for similar devices.

Analyze Data and Compile Findings: Analyze the collected data to identify any gaps, risks, or additional clinical evidence needed. Document these findings thoroughly.

Prepare the CER Document: Ensure the report is comprehensive, covering all necessary regulatory aspects, and follows the latest guidelines.

Submit and Maintain the CER: Submit the CER to the relevant authorities and continuously update it based on post-market surveillance and new clinical data.

For a deeper understanding of how to navigate the CER submission process, refer to this detailed guide: A Guide for Medical Device Organizations in Clinical Evaluation Report (CER) Submission. This resource offers practical insights to help you streamline your CER submissions and ensure regulatory compliance.

[tritonmarketresearchamey]

Epilepsy Devices Market: Tech Trends 2022-2028

According to the WHO, epilepsy is a chronic brain disorder that affects 50 million individuals, making it one of the most prevalent neurological conditions worldwide. It is estimated that with access to early detection and appropriate care, 70% of the population diagnosed with epilepsy may live seizure-free. According to our estimates, the global epilepsy devices market was valued at $669.73 million in 2021 and is expected to reach $1157.58 million by 2028, growing at a CAGR of 8.16% during the forecast period 2022-2028.

Government institutions worldwide are focused on starting initiatives to create innovative epilepsy devices with AI and machine learning integration. Additionally, organizations that support research need to encourage high-quality comparative efficacy trials and sufficient data to guide therapeutic practice in epilepsy. As a result of these technologically advanced equipment and increasing drug trials, the market for epilepsy devices is anticipated to grow throughout the forecast period.

Epilepsy Devices - Key Detection Methodologies

Currently, several wearable technologies can detect seizures, collect data, and alert caregivers. Although with technological advancements, the ability to detect seizure-related alterations increases. Top trends backing this tech boom include:

Wearable devices are estimated to be the fastest-growing device type during the forecast period. Monitoring epileptic patients is crucial, as 20% of epileptics only have seizures while asleep, 40% only have seizures while awake, and 35% have seizures both when they are awake and asleep. With technologically advanced non-invasive wearable sensors, measuring accelerometry, photoplethysmography (PPG), electrodermal activity (EDA), electromyography (EMG), and other signals outside of the conventional clinical environment have become effective.

Vagus Nerve Stimulation (VNS) has emerged as the fastest-growing application category. VNS Therapy has been approved by the U.S. Food and Drug Administration (FDA) as an add-on therapy for age 4 years and above to treat drug-resistant epilepsy or refractory epilepsy. VNS has been reportedly beneficial in many patients, including the ones with posttraumatic epilepsy (PTE). PTE is a common consequence of traumatic brain injury and accounts for about 20% of symptomatic epilepsy cases.

As per estimates, Electroencephalography lead the detection and prediction devices type segment in 2021 and is expected to maintain its stronghold during the forecast period. There is growing interest in wearable or mobile EEG solutions that allow long‐term EEG monitoring in an easy‐to‐use format. Despite the availability of these new EEG solutions, their adoption is still limited in clinical practice, mainly because of the unfamiliarity of healthcare and biomedical research sectors with the technology and its application.

Strategic Initiatives and Government Approvals

Different end-users, such as homecare settings, hospitals, and clinics, are utilizing epilepsy devices. The manufacturers of epilepsy monitoring devices are likely to gain prominent business opportunities from the hospital & clinics segment owing to the rise in the use of EEG monitoring and emergency medical services.

The government authorities of several developing nations, including India and China, are focusing on developing sturdy healthcare infrastructure. As a result, operating players are expected to gain sizable growth prospects in the region during the forecast period. Owing to this, the Asia Pacific epilepsy devices market is anticipated to witness the fastest growth with a CAGR of 8.38% throughout the forecast period.

In addition, companies are also focusing on launching novel devices for children. Moreover, companies are also using organic and inorganic strategies, including mergers and acquisitions, to stay ahead of the competition. Some of these include:

In September 2022, Boston Scientific Corporation’s current-generation WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use labeling. The company also received FDA 510(k) clearance for the EMBOLD Fibered Detachable Coil, which reduces the blood flow rate in the peripheral vasculature.

In July 2022, Medtronic PLC received FDA 510(k) clearance for its UNiD Spine Analyzer v4.0 planning platform to leverage machine learning.

In November 2021, NeuroPace, Inc. received an Investigational Device Exemption (IDE) from the FDA to study the company’s RNS System to treat primary generalized epilepsy in patients aged 12 and above.

Way Forward

With technological advancements, epilepsy detection devices with exceptionally low false alarm rates have recently been developed. They are based on computationally intensive algorithms and employed in implanted systems for pre-surgical monitoring. Recent research has produced encouraging findings for probabilistic seizure risk projections using long-term wearable technology and electronic seizure diaries. The symptoms, mood, and cognitive function of an individual may also have predictive significance. Therefore, technological advances in non-invasive wearable sensors are anticipated to create growth opportunities for the epilepsy devices market.

 

FAQ:

Q1) What are the key end-users of the epilepsy devices market?

The key end-users in the epilepsy devices market include hospitals & clinics, neurology centers, homecare settings, and other end-users.

Q2) Which region leads the global epilepsy devices market?

North America leads the global epilepsy devices market.

[soumyafwr]

Network Connected Medical Devices Market Share, Overview, Competitive Analysis and Forecast 2031

[mitalipingale]

The Cardiac Medical Device Market in 2023 is US$ 63.25 billion, and is expected to reach US$ 108.84 billion by 2031 at a CAGR of 7.00%.