#Medical Devices Report

[wissenresearchllc]

Point-of-Care Diagnostics Market: A New Era in Quick Healthcare Solutions

The Point-of-Care (POC) diagnostics market is on the rise, fueled by the growing need for rapid and convenient healthcare solutions. POC testing delivers accurate results for conditions like diabetes and infections directly to patients, minimizing the need for centralized lab testing. This advancement not only enhances patient care but also contributes to the efficiency of global healthcare systems. For deeper insights into this transformative market, visit Wissen Research's analysis here.

[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.

[mohitsper]

Asia Pacific Surgical Robotics Market Size and Share, Rising Trends, Revenue, Growth Drivers, CAGR Status, Challenges and Future Opportunities 2033

According to SPER Market Research, the report ‘Asia Pacific Surgical Robotics Market Size- By Type, By Application – Surgical robots are advanced medical devices widely utilized in the healthcare sector to aid surgeons in complex procedures. Their popularity stems from numerous benefits, such as unmatched precision, minimally invasive techniques, reduced scarring, enhanced visibility, and faster patient recovery. These robots are increasingly seen as the standard of care, with surgeons choosing them to improve procedure accuracy and patient outcomes. Additionally, surgical robots enhance surgeon ergonomics, reducing physical strain, increasing freedom of movement, enhancing visualization, and providing greater flexibility at the console.

Regional Outlook, Competitive Strategies and Segment Forecast to 2033’ projects that the Asia Pacific Surgical Robotics Market will reach USD 5.51 billion by 2033, growing at a CAGR of 11.81%.

Key Market Drivers

The Asia-Pacific region is witnessing substantial growth in the surgical robotics market due to the evolution of medical procedures and healthcare infrastructure. Key factors include a rising preference for minimally invasive surgeries and growing awareness among medical professionals about the benefits of training, simulation, and continued medical education. Technological advancements are not only reshaping surgical techniques but also improving patient outcomes and reducing recovery times. With increasing acceptance of surgical robotics by healthcare providers, the Asia-Pacific region is establishing itself as a global leader in surgical robotics. This technology holds transformative potential for future healthcare by enhancing precision, productivity, and minimally invasive practices.

Market Challenges

Operating surgical robots requires highly specialized skills, demanding deep knowledge of both surgical procedures and robotic systems. However, there is a notable shortage of professionals in the Asia-Pacific region with these capabilities. The lack of adequate training programs and the high costs associated with acquiring these skills contribute to this shortage. Rapid advancements in surgical robotics also require ongoing training, adding further strain. This shortage of skilled operators poses a significant challenge for the growth of the surgical robotics market in Asia-Pacific, potentially limiting the region’s ability to meet the rising demand for robotic surgeries.

For a free sample report, visit: https://www.sperresearch.com/report-store/asia-pacific-surgical-robotics-market.aspx?sample=1

Impact of COVID-19

The COVID-19 pandemic significantly impacted the Asia-Pacific surgical robotics market, underscoring the need for modern healthcare technologies to address the crisis effectively. The pandemic accelerated the adoption of telemedicine and remote surgery, driving demand for robots capable of performing minimally invasive surgeries with minimal human intervention. However, economic challenges and postponed non-urgent procedures during the pandemic led healthcare facilities to delay investments in medical robotics.

In 2022, China led the Asia-Pacific surgical robotics market by market share. Key players in this sector include Stryker Corporation, Intuitive Surgical, Inc., Mazor Robotics, THINK Surgical Inc., among others.

Asia Pacific Surgical Robotics Market Segmentation

By Type: Based on the Type, Asia Pacific Surgical Robotics Market is segmented as; Surgical Systems, Instruments and Accessories, Services.

By Application: The Asia Pacific Surgical Robotics Market is divided into the following segments based on applications- Head and Neck Surgery, Orthopaedic Surgery, Cardiology Surgery, Gynaecology Surgery, Urology Surgery, and Other Surgeries.

By Region: This research includes data for China, Japan, India, South Korea, Australia, Indonesia, Others.

For More Information, refer to below link: -

Asia Pacific Surgical Robotics Market Outlook

Related Reports:

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Mexico Surgical Devices Market Size- By Product, By Application- Regional Outlook, Competitive Strategies and Segment Forecast to 2033

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[pricedaniel238]

Antimicrobial Coatings for Medical Devices Market: Driving Affordable and Sustainable Solar Energy Growth and Firecast 2023-2033

The antimicrobial coatings for medical devices market is experiencing significant growth as the healthcare industry increasingly emphasizes infection control and patient safety. Medical devices, from catheters to surgical instruments and implants, are prone to bacterial contamination, which can lead to serious infections and complications. Antimicrobial coatings are designed to prevent the growth…

[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…

[tamer200333]

Urgent treatment appeal please stop

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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.

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

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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.

[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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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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[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.