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FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance

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Today, the U.S. Food and Drug Administration issued a draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits and risks of LASIK devices.  

women s black mascara. LASIK surgery,
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“It is important to provide patients with comprehensive labeling that clearly describes the risks involved with LASIK surgery, including potential adverse effects such as dry eye, pain and discomfort, and visual symptoms,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “These proposed labeling recommendations, based on extensive consultation with stakeholders and patients, are intended to present information about LASIK in language that is easy to read and understand and include images that convey visual symptoms that could occur following LASIK. The draft guidance is designed to support discussions that patients should have with their eye care providers about the benefits and risks of LASIK to help them make informed decisions before proceeding with the surgery.”  

LASIK is an outpatient surgical procedure that permanently reshapes the cornea to change the way the eye focuses light rays onto the retina at the back of the eye. LASIK surgery is intended to correct common vision problems such as nearsightedness, farsightedness, and astigmatism and to reduce a person’s dependency on eyeglasses and contact lenses. 

The draft guidance “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations,” details the FDA’s proposed recommendations for the content and format of patient labeling for LASIK devices, including general information about the surgical procedure; indications for use; benefits; procedure alternatives; contraindications, warnings and precautions; risks; what to expect before, during and after surgery; clinical study information; and manufacturer contact information. In addition, the draft guidance proposes the inclusion of a patient decision checklist as part of the patient labeling information that physicians provide to their patients prior to the procedure. To ensure the patient decision checklist is clearly understood by patients, the proposed checklist includes, among other information, who is a good candidate for LASIK, what to expect after surgery, and a summary of long-term risks of the procedure. It also proposes that the patient and physician sign the checklist to acknowledge it was read and discussed. 

The FDA collaborated with external experts on research efforts that informed the recommendations in the draft guidance. The agency, in collaboration with the National Eye Institute and the Department of Defense, conducted research as part of the LASIK Quality of Life Collaboration Project to help better understand the potential risk of problems that can occur after LASIK. This project led to the development of the Patient-Reported Outcomes with LASIK PROWL Symptoms and Satisfaction (PROWL-SS)External Link Disclaimer, questionnaire, qualified through the FDA’s Medical Device Development Tools (MDDT) program.  

By issuing draft guidance for public comment, the FDA is encouraging feedback on the proposed labeling recommendations from patients, health care providers and stakeholders. The FDA will continue to monitor the latest scientific data related to LASIK and work with professional medical societies and patient advocacy groups to help ensure that risk information about LASIK devices is disseminated to patients, as new information becomes available. 
 

Related Information

Source: FDA

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    Rod: A creative force, blending words, images, and flavors. Blogger, writer, filmmaker, and photographer. Cooking enthusiast with a sci-fi vision. Passionate about his upcoming series and dedicated to TNC Network. Partnered with Rebecca Washington for a shared journey of love and art. View all posts

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San Diego Cosmetic Dentist Discusses How to Prevent Bone Loss After Losing a Tooth

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SAN DIEGO, CA, USA /EINPresswire.com/ — Missing teeth can have obvious consequences for your smile, but many people are not aware of how tooth loss affects their oral health, general well-being, and even their facial shape. Once a tooth is detached from the gums, there is no tooth root to stimulate the underlying jawbone; unfortunately, this often causes the bone structure to recede and lose volume. Bone loss can raise a number of aesthetic and functional concerns — particularly when a tooth has been without a replacement for a significant amount of time — including the shifting of surrounding teeth, an increased risk of gum disease, and changes in your jaw structure. In general, greater bone loss is experienced the longer an absent space remains unfilled. While jawbone recession can be debilitating, San Diego cosmetic dentist Landon Libby, DDS discusses potential solutions for bone loss to prevent further damage and regenerate additional bone density.

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According to Dr. Libby, implant dentistry can offer a myriad of benefits for individuals with missing teeth, including the ability to maintain bone volume and preserve the full integrity of the jawbone after tooth loss. Using dental implants, implant dentistry aims to replace a missing tooth with an artificial tooth root and a custom-made restoration indistinguishable from a patient’s natural teeth. A titanium post is implanted into the jawbone during treatment, which serves as the “replacement” tooth root. Unlike other tooth replacement options that are not surgically affixed to the underlying bone, dental implants and implant-supported restorations promote new bone regeneration. Not only can this enhance a patient’s oral health and strengthen their jawbone, but implant restorations are also considered to look and feel the most similar to natural teeth. Best of all, implants can be used to replace a single tooth, multiple teeth in a row, or even a full dental arch.

It’s important to understand that every patient may not be a good candidate for dental implants, and bone grafting may be necessary prior to treatment to provide more support for implant placement. As a multi-stage process involving oral surgery, Dr. Libby stresses the importance of selecting an experienced, compassionate, and qualified dental team to place implants and provide a seamless patient experience.

About Landon Libby, DDS
Dr. Landon Libby is a Mission Valley-based cosmetic dentist who provides cosmetic, restorative, and family dentistry treatments for patients in and around San Diego. As a DOCS-certified dentist with training in sedation dentistry, Dr. Libby strives to enhance patient comfort during every stage of treatment and redefine what it means to “go to the dentist.” After receiving his Doctor of Dental Surgery (DDS) from the Loma Linda University School of Dentistry, Dr. Libby went into private practice and has been serving the dental needs of the San Diego community for years. Dr. Landon Libby is available for interview upon request.

To view the original source of this release, click here: https://www.sandiegodentist.net/practice-news/san-diego-cosmetic-dentist-discusses-how-to-prevent-bone-loss-after-losing-a-tooth/

Source: Rosemont Media


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Healthcare Education Market – Skilling Up for Scalpels: Inside the Thriving Healthcare Education Industry

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PUNE, MAHARASHTRA, INDIA /EINPresswire.com/ — Healthcare Education Market Perspective

The Global Healthcare Education Market size was worth USD 103.64 billion in 2022 and is estimated to grow to USD 202.75 billion by 2030, with a compound annual growth rate (CAGR) of approximately 8.75% over the forecast period. The report analyzes the healthcare education market’s drivers, restraints/challenges, and their effect on the demands during the projection period. In addition, the report explores emerging opportunities in the healthcare education market.


healthcare education market
Medical professionals watching webinar on online platform. People having virtual class flat vector illustration. Online education, medicine concept for banner, website design or landing web page

Healthcare Education Market Developments

• In 2023, HealthStream (US) purchased Electronic Education Documentation System, LLC (US). This acquisition will broaden Healthstream’s ecosystem by bringing a cutting-edge, cloud-based continuing education management system for healthcare organizations and delivering cutting-edge solutions in the form of Software-as-a-Service (SaaS).

• In 2022, To promote access for surgeons and benefit more patients across the US, GE Healthcare (US) and DePuy Synthes (US) worked together to make GE Healthcare’s OEC 3D Imaging System and DePuy Synthes’ extensive product line more widely available.

Get Access to Smart Book @ https://nforming.com/blog/healthcare/healthcare-education-market-analysis-report-industry-outlook-latest-development-and-forecast-to-2030/

Healthcare Education Market’s Top Driver

Increasing need for skilled healthcare workers to drive market growth

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The market for healthcare education is expanding significantly due to the increasing need for skilled healthcare workers. The market for healthcare education is being significantly shaped by the growing demand for qualified healthcare workers. The demand for skilled physicians, nurses, allied health workers, and administrators who can deliver high-quality healthcare services is rising as the world’s population continues to expand and get older. The rising incidence of chronic illnesses and complicated medical disorders that need specialized care has increased this demand. Additionally, the need for healthcare professionals is growing outside conventional clinical responsibilities. The demand for non-clinical positions such as healthcare administrators, informatics experts, and others is also growing. As a result, healthcare education incorporates a variety of academic fields to produce a workforce that is well-rounded and able to meet the many demands of the healthcare sector.

Healthcare Education Market: Regional Landscape

Asia Pacific dominated the Healthcare Education market in 2022

There is a sizable and constantly expanding population in the Asia Pacific region, which generates a sizable demand for healthcare services. The demand for qualified and trained healthcare personnel grows proportionally as healthcare systems enlarge to meet this demand. Additionally, greater investments in healthcare infrastructure, including educational institutions, have been made as a result of the Asia Pacific region’s economic expansion. Governments and commercial organizations are becoming more aware of how crucial a strong healthcare education system is to the development of healthcare services.

Healthcare Education Market Top Players: Stryker (US), SAP (Germany), Adobe (US), Infor (US), Oracle (US), HealthStream (US), Symplr (US), Elsevier (Netherlands), Articulate (US), PeopleFluent (US), Fujifilm Corporation (Japan), GE Healthcare (US), Trivantis Corporation (US), Koninklijke Phillips (Netherlands), Siemens Healthineers (Germany), Coursera (US), and IBM (US).

Healthcare Education Market: Segmentation

The global healthcare education market has been segmented into provider, delivery mode, application, and end-user.

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Based on universities, educational platforms, and medical simulation are segments of the global healthcare education market. The university segment to improve the business and department workers, the requirement for continuous learning in a field that is rapidly evolving, partnerships with healthcare organizations, and the emphasis on patient-centered care and interprofessional collaboration are all factors driving the growth of universities and academic institutions in the market for healthcare education solutions. The aforementioned elements help healthcare education programs grow and evolve to satisfy industry demands.

Based on delivery mode, the market is classified into classroom-based, and e-learning. In 2022, the e-learning processing category dominated the global market. Due to a variety of online learning platforms, students have access to educational resources like lectures, videos, quizzes, and other resources in a digital setting. Students can learn at their own pace and convenience in e-learning environments, which usually offer flexibility. Coursera, Blackboard, and Moodle are a few popular e-learning platforms. Because of the COVID-19 pandemic, e-learning platforms have proliferated as a medium of delivery, and this trend is anticipated to continue during the projected period. The overall revenue for Coursera in 2022 was US$523.8 million, a 26% increase over 2021, while the gross profit was US$249.5 million, a 33% increase over 2021.

Based on application, the market is classified into neurology, cardiology, and pediatrics. In 2022, the cardiology category dominated the global market. It is anticipated that factors including the increased prevalence of cardiovascular diseases (CVD), technological improvements, and online courses will raise demand for educational solutions. According to the WHO’s 2021 update, CVDs encompass illnesses like coronary heart disease, cerebrovascular disease, rheumatic heart disease, and others.

Based on end-users, the market is classified into students and physicians. In 2022, the student category dominated the global market. Student prospects have increased as a result of the growing accessibility and availability of healthcare education alternatives, notably online and remote learning options. Students can learn at their own pace, from any location, at any time, and with the help of digital tools and online platforms. This accessibility makes it easier for people from different backgrounds to enter the healthcare industry by allowing students to pursue healthcare education while juggling other responsibilities.

Trending Smart Book Reports:

Cardiac Biomarkers Market – https://nforming.com/blog/healthcare/cardiac-biomarkers-market-projected-to-grow-at-a-steady-cagr-of-12-60-during-forecast-period-2023-2030/

Fitness Trackers Market – https://nforming.com/blog/technology/global-fitness-trackers-market-insights-top-manufacturers-analysis-trend-and-demand-forecast-to-2030/

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Coca-Cola Recall Alert: Thousands of Cans Pulled From Shelves in Two States

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In a significant recall notification, Coca-Cola has announced the withdrawal of over 10,000 cans of its popular beverage due to concerns over foreign object contamination. This announcement was initially made on March 6, and affected cans were sold in the states of Illinois and Wisconsin.

This week, the U.S. Food and Drug Administration (FDA) classified the risk level of this recall as Class 2. This designation indicates that consuming the affected Coca-Cola “may cause temporary or medically reversible adverse health consequences,” although the chances of serious health consequences are deemed to be remote.

Which Coca-Cola Products Were Recalled?

The recall impacts a total of 864 packs of 12 cans of Coca-Cola, amounting to 10,368 cans in total. The specific details of the recalled products are as follows:

  • Product Description: Coca-Cola Original Taste, 12 Fl Oz
  • Can UPC: 0 49000-00634 6
  • 12-Can Pack UPC: 0 49000-02890 4
  • Date Code: SEP2925MDA
  • Time Stamp: 1100-1253

Which States Are Affected?

The recall specifically concerns Coca-Cola cans distributed in the following states:

  • Illinois
  • Wisconsin

Why Were the Coca-Cola Cans Recalled?

The FDA has reported that these Coca-Cola cans were recalled due to contamination with a foreign object, in this case, plastic. Such contaminants can inadvertently enter food and beverage products at various stages during the production process, posing a safety risk if ingested. It is important to note that the FDA report did not indicate any associated injuries related to this specific recall

If you have purchased Coca-Cola cans with the above UPC codes in Illinois or Wisconsin, it is recommended that you refrain from consuming the affected products. Instead, please return them to the store where you purchased them for a full refund or exchange. Staying informed about product recalls is crucial to consumer safety, and it is always advisable to check for the latest updates from the FDA and Coca-Cola regarding product safety issues. For any additional questions, feel free to reach out to Coca-Cola directly or visit the FDA’s website. Stay safe!

Related links:

https://people.com/fda-announces-coca-cola-recall-for-plastic-contamination-11702963

https://nypost.com/2025/03/25/business/coca-cola-recalls-10k-soda-cans-over-foreign-object-contamination/

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Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section covers you. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

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