Artificial Intelligence Learning Action Plan Released by FDA

The United States Food & Drug Administration (FDA) has released their first Artificial Intelligence (AI) and Machine Learning (ML)-Based Software as a Medical Device (SaMD) Action Plan. Detailed throughout the plan is a multi-pronged approach to “Advance the Agency’s oversight of AI/ML-based medical software,” according to the article.

Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH) said, “This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD. The plan outlines a holistic approach based on total product lifecycle oversight to further the enormous potential that these technologies have to improve patient care while delivering safe and effective software functionality that improves the quality of care that patients receive. To stay current and address patient safety and improve access to these promising technologies, we anticipate that this action plan will continue to evolve over time.”

Five actions that the FDA intends to take based on the action plan include:

  • Further developing the proposed regulatory framework, including through the issuance of draft guidance on a predetermined change control plan (for software to learn in time)
  • Supporting the development of good machine learning practices to evaluate and improve machine learning algorithms
  • Fostering a patient-centered approach, including device transparency to users
  • Developing methods to assess and enhance machine learning algorithms
  • Advancing real-world performance monitoring pilots

This action plan was sparked by stakeholder feedback and is implemented as a response to the discussion. The FDA welcomes continual input and will continue to collaborate and build a coordinated approach in AI/ML areas.

The FDA is responsible for the safety and security of America’s food supply, cosmetics, dietary supplements, products that emit radiation, and regulating tobacco products. The agency also protects public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, biological products for human use, and medical devices.

To read more about the FDA’s Action plan, see the full press release on their website.

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Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.

Study Shows Drastic Decline in Cancer Screenings During COVID-19 Surge

According to a study published in JAMA Oncology by researchers at Dana-Farber/Bringham and Women’s Cancer Center, researchers documented a sharp drop in cancer and pre-cancer diagnoses at the Northeast’s most extensive health care system. Due to the first peak of the COVID-19 pandemic, a decrease in the number of screenings occurred.

Documented as one of the first studies to examine the impact of COVID-19 on cancer diagnoses, the findings confirm concerns that restrictions might have delayed the detection of many cancers. In the months following the initial peak, cancer screenings and diagnoses rebounded to pre-pandemic levels.

“It’s widely thought that fewer people were screened for cancer and pre-cancerous lesions during the first surge of the pandemic, because limitations on non-urgent medical procedures, restrictions on patient volume, patients’ concerns about the spread of the virus, and the need for social distancing,” said Ziad Bakouny, M.D. MSc, a co-author of the study. “For this study, we wanted to document the extent of this deadline, and its impact on cancer diagnoses, at a major U.S. healthcare system.”

Patient data from the Massachusetts General Bingham system of hospitals were used for the study. The number of mammograms, colonoscopies, Papinicolaou (“Pap”) tests for cervical cancer, prostate-specific antigen (PSA) tests, and low-dose Computed Tomography (CT) tests was all tracked for four three-month periods. March 2 to June 2, 2020, the previous three months, the subsequent three months, and the same three months in 2019 were all used in the study.

During the peak period, the statistics show a sharp decline in cancer screenings. In 2019, between March and June, 60,344 patients underwent screening exams. In 2020, a total of 15,453 patients had screening exams, compared to 64,269 in the previous three months. In the post-peak three-month period, screening levels mostly recovered to 51,944.

Unexpectedly, cancer diagnoses also declined during the COVID-19 peak. The researchers estimated that roughly 1,438 cancers and pre-cancerous growths were left undiagnosed during that period. Cancers are easier to treat when detected at early stages, so those that were overlooked could potentially be worse or life-threatening.

Bakouny remarked, “It’s reassuring, though, to see that in the three-month post-peak period, the number of screening tests and diagnoses resulting from those tests returned to near-normal level.”

Co-senior author Quoc-Dien Trinh, M.D., of Bingham and Women’s Hospital (BWH), said, “This investigation is especially timely given that we are currently dealing with a second, and potentially worse wave of the pandemic. We have learned to leverage a redesigned patient flow, increased use of telehealth, and made other accommodations to allow our patients to continue in receiving cancer screenings in the safest possible environment.”  

Acceletronics is an industry leader in delivering the best equipment performance and service reliability from CT Scanners and Linear Accelerators across all major brands and models. Call 610-524-3300 or visit our website: https://www.acceletronics.com.

Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.

PC Sales See Biggest Upswing in Ten Years

Thanks to the COVID-19 pandemic, working from home and shelter-in-place orders have driven Personal Computer (PC) sales to the highest rate in a decade.

IDC, a PC company, said global shipments of PCs in 2020 reached 302.6 million devices, a 13 percent increase from 2019. The jump was the largest annual gain since 2010, with the volume being the largest since 2014, which was notable since six of the past ten years saw declines. Gartner Research also showed a boost in PC shipments, with steady growth that was the highest measured since 2010.

Jitesh Ubrani, research manager for IDC’s mobile device tracking team, said, “A lot of volume early in the year was because companies had people working at home. Enterprises purchased large numbers of laptops to equip those suddenly-remote workers; the sales volume at time sufficient to completely throttle the component supply chain.”

With many school districts focusing on remote learning, many tried to equip students with PCs (low-cost laptops), to learn adequately. Families with school-aged children also added PCs to households when districts could not afford to cover costs for every child.

Gaming PCs also proved useful during the pandemic, when people were hunkered down at home for long periods of lockdowns and quarantine. Entertainment-wise, families needed distractions, and games became an easy target. Those interested in playing games on old PCs were in for a surprise, as many didn’t make the cut for gaming, crafts, or other projects. Therefore, those consumers were forced to purchase new devices, which also helped drive sales.

Acer, Apple, Dell, HP, and Lenovo reported the highest PC shipment numbers for 2020, according to IDC. The highest year-over-year growth rate went to Apple, coming in at roughly 22.8 million. Chromebook, Google’s laptop powered by a Chrome-based operating system, also surged in 2020. Shipments grew by more than 80 percent, totaling approximately 30 million.

Ryan Reith of IDC, leader of the firm’s mobile device tracking group, said, “Demand is pushing the PC market forward and all signs indicate this surge still has a way to go. In retrospect, the pandemic not only fueled the PC market demand but also created opportunities that resulted in a market expansion.”

Consumer shipments are projected to increase through 2024. “We’ll see a lot of demand in 2021 because some of that went unfulfilled in 2020. Those orders slipped from the end of 2020 into early 2021,” Ubrani said.

For all your computer needs, contact the experts at CPS. Our fully-trained, knowledgeable staff can help troubleshoot or answer any computer questions.

Founded in 1994, Creative Programs and Systems provides professional results for all computer needs. We design, create, and code an array of custom software programs and websites; implement internet marketing strategies for enhanced Search Engine Optimization (SEO) results; repair and provide support for computers of both residential and professional nature; build custom systems and servers, and offer secure data backups. Need assistance or want to learn more? Call us at 810-224-5252 or e-mail info@cpsmi.com.

Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.

EB Mortgage Site Goes Live

EB Mortgage has a new website! We launched in February 2021 and we’ll keep you up-to-date with the latest news, tips/tricks, updates, and information on our blog. We are a wholesale mortgage company providing our clients with a new home purchase, refinance, and commercial loan options. With our low rates, we have more products, more options, and more solutions.

We offer three different types of services:

Purchase
Buying a new home? We can help! Let us determine what you can afford based on your budget. We combine multiple financing options, and our extensive knowledge will steer you in the right direction throughout the process. Our experts have all of the tools needed to help ease your stress and streamline your experience.

Refinance
Need money now? We can help! Refinancing your home enables you to lower your rate and reduce monthly payments and interest costs. Credit card or other debts can be repaid entirely if the borrower qualifies. Adjustable-rate mortgages (ARM) can be converted to a more secure, fixed-rate mortgage. Two mortgages can be merged to lower the overall rate. With so many options to choose from, our clients successfully trek the refinance process with our experts’ professional guidance.

National Commercial Lending
Operating a commercial property? We can help! Commercial loans typically cover major capital expenditures and operational costs. At EB Mortgage, we work with companies small and large to allocate assets for projects that the business might not have otherwise been able to afford. We offer several options to suit our clients’ needs.

Want to learn more about our purchase, refinance, or commercial lending programs? Our experts are standing by to help get you pre-approved today.

EB Mortgage is a locally-owned mortgage company with experts in a new home purchase, refinancing, and commercial loans. Our wholesale rates can’t be beat. We offer more products, more options, and more solutions. Our “3C” Process is simple: complete our pre-approval request, consider options based on your requirements, and choose the offer that suits your needs best. Call us at 866-246-0516 or e-mail contact@ebwmtg.com today.

Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.

Smart Meters to Increase in Popularity Worldwide

Around the world, the use of smart meters is continuing to rise. According to a report produced by the Indian firm Prescient & Strategic Intelligence Private Limited, the global smart meter market will reach $20 billion in revenue by 2030. The compound annual growth rate is projected at 4.9 percent, from $13.1 billion in 2019, according to the report.

The study explained, “The market is growing due to the rising focus on smart grids, rising awareness among people regarding energy conservation, and surging focus of governments on replacing conventional meters with smart meters.”

For the past six years, the Asia-Pacific region has been dominating the smart meters market. Experts project this to swell at the fastest pace over other regions, as these nations are widely investing in the implementation of smart meters. China has been leading the way, investing heavily in smart meter infrastructure and grid projects. The regional market is set to expand due to increasing government initiatives.

According to the report, smart meter software is projected to expand quicker than hardware; this is especially true for those that can identify anomalies in utility consumption patterns, making billing more accurate. Correct billing is a driving factor for the growing installation of smart meters.

Additionally, the two-way communication feature of smart meters that support a two-way flow of information is driving the market increase. End-users can collect electricity usage information about all appliances at regular intervals.

“Smart meters make use of the local area network for collecting this data, which is then transmitted to the utility center using wide area network. The utility can also send signals, command, and information to the device at user’s end if needed,” the study wrote.

The software will be used for data collection, meter data management platforms, and to manage and operate the smart meters.

The smart meter market share is currently dominated by electric smart meters, as more governments worldwide encourage their installation. Water smart meters are expected to have the highest compound annual growth rate, and gas smart meters will grow at a slower pace.

Check out Research and Markets to find out more information or read the full study. 

J&P Electrical is a full-service electrical equipment company. At J&P, we supply contractors, end-users, and supply houses with new surplus, quality reconditioned, and obsolete electrical equipment. We also purchase a wide range of electrical equipment such as bus plugs, ducts, panel switches, substations, and transformers. Call us at 877-844-5514 or visit us at https://www.jpelectricalcompany.com.

Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.

Pool Building: A Timeline

Designing a pool takes roughly eight to twelve weeks on average. Winter will turn to spring before we know it; by then, it will be a primetime season for pool building. If you are planning on having a pool built, it’s best to start that process now. But just how does it all work? Read on for the details.

Design: 1 to 4 weeks
Whether you already had a pool or want to build something brand-new and fresh, it’s a good idea to meet with a pool designer to review your overall vision. With innovations in 3D modeling technology, your dream backyard pool will be a reality in no time.

Permits: 2 to 6 weeks
Most cities, townships, and counties require residential building permits before construction can begin on an inground pool. Permits are meant to communicate that you are building safely and legally. Neighbors, city officials, and local professionals can rest assured the project is being completed according to the law. It can take one to six weeks to process forms, wait times, and gain permit approval.

Excavation: 1 week
Access to the dig site can be restricted by utility lines or other challenges. The overall digging process, once cleared, will only take one or two days. During busier seasons, pool excavators might be backed up with other customers who scheduled before you. Even more reason why you should start planning sooner than later.

Rough materials: 1- 2 weeks
The steel, plumbing, and electrical will all need to be routed to accommodate your design. Your lighting, water features, spas, and overall system will need to be considered. Depending on the size and complexity of the pool, these materials are essential for the overall aesthetic.

Pool interior: 1 to 3 weeks
Vinyl, fiberglass, gunite, diamond brite, etc., are vital aspects of the pool’s interior. Crews might need to be scheduled for installation and plastering. After everything is set, it might take some time for the materials to cure.

Landscaping: 1 to 4 weeks
Decks, landscaping, and other custom features consisting of water or lighting can take a couple of weeks to finalize. Depending on the number of features you are looking to add, the process can be shorter or longer.

Looking to remodel or refresh your pool? Contact the professionals at Pound Pool Plastering today.

Pound Pool Plastering offers free estimates and complete pool renovations. Dale Pound, owner, personally oversees each pool project to ensure the highest quality is delivered. We offer Diamond Brite, Sunstone, Hydrazzo, Marcite, Pebble finishes, Bead Crete, tile choices, coping stones, etc. We are pool renovation experts – contact us today at 248-476-4544 or poundpool@sbcglobal.net.

Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.

Five Tips to Maximize Your Brand Visibility with Experiential Marketing

As you review your brand’s marketing strategy for the new year, you might be leaning toward experimental marketing, which can provide more of a Return on Investment (ROI) than traditional advertising sources. Experiential marketing (also known as engagement marketing) invites an audience to interact with a business in a real-world situation. Using hands-on, tangible branding material, the company can showcase its goals, values, and offerings.

  1. Consider your audience: While experimental marketing is a wonderful way to connect with your audience, in the COVID-19 era, it might not be the best strategy for everyone. Before implementing your plan, consider who you are trying to reach. Think about the best way to connect with them in the safest and most comfortable way possible.
  2. Utilize technology: The best way to reach your customers might be through a social media platform such as Facebook Live, Instagram, or YouTube. There are many tools available online to orchestrate virtual events, meetings, and the like. These applications are beneficial for complying with state or local COVID-19 protocol. Moreover, you can expand your reach through technology, as some people might not have participated if not for a virtual setting.
  3. Create focus groups: When looking to implement experiential marketing, develop unique ideas through focus groups. Discover how these individuals react to specific strategies to gauge how your audience will respond. Engaging focus groups will help predict your overall audience reactions.
  4. Be bold: Fully understand your marketing strategy while delivering a clear and concise message. Create a world where your audience can fully engage in your story. Provide delightful, shocking, and surprising marketing campaigns. Showcase your brand and give your audience tools to share it with the world.
  5. Plan accordingly: Take educated risks without rushing too much. It’s easy to get excited and start implementing ideas, but don’t get sloppy. Your audience of customers can easily scrutinize, so make sure your strategy is strong, direct, and can stand up to opposition.

Omega Benefit Strategies provides seniors who are affiliated with credit unions, labor unions, and associations an educational resource for Medicare. Our turnkey marketing package seamlessly integrates with existing market strategies. We can help businesses increase new member acquisitions, bolster retention, cross-sell opportunities via our “scorecard” system, and even earn an ancillary revenue stream. Accommodating any size membership, we maintain exemplary member service and offer top-notch products. Contact us today by going to www.omegabenefit.org or call 888-404-5049.

Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.

Will Medicare Cover the COVID-19 Vaccine?

As new COVID-19 vaccines are approved in the United States, health departments in all 50 states received their first round of vaccines. Frontline healthcare workers and residents of long-term care facilities were the first ones to receive doses.

Medicare will cover the coronavirus vaccine, thanks to the CARES Act, which was passed by Congress in March 2020. Medicare Part B is required by the CARES Act to 100 percent cover FDA-Approved COVID-19 vaccines. This means if you are a Medicare beneficiary, you will have no out-of-pocket costs for the COVID-19 vaccine.

The COVID-19 vaccine was developed with $10 billion in funding from the federal government. Under the CARES Act, the vaccine is free to all. The Medicare Trust Fund covers 100 percent of the vaccine’s cost for those Medicare and/or Medicaid beneficiaries. Private insurers are required to offer the vaccine for free to plan members. No money is allowed to be collected from vaccine patients by providers who administer the vaccine. Even if the insurance company (or Medicare) doesn’t reimburse the provider, they still are banned from billing the patient for the balance.

Those without insurance can get the vaccine for free under the CARES Act. Providers who administer the vaccine to people who do not have health insurance can submit a reimbursement request.

If you get the COVID-19 vaccine and receive a bill, it might have been for other services not related to the shot. If your only reason for an office/doctor visit is due to COVID-19, you should not receive a bill. If you received other services in the same visit, your regular Medicare cost-sharing would apply.

Currently, the CARES Act specifies only two Federal Drug Administration (FDA)-approved vaccines for COVID-19: the Pfizer/BioNTech vaccine and the Moderna vaccine. Several other vaccines are in development and testing stages; if they are approved for use by the FDA, Medicare will cover those also. Both approved vaccines require two doses (or shots) for complete immunity. Depending on the shot you obtained, you should receive a second dose three or four weeks later.

The chances of getting COVID-19 from the vaccine are impossible. Most vaccines introduce a live virus into the body to provoke an immune response. The Pfizer/BioNTech and Moderna vaccines do not include any actual coronavirus. Instead, they use messenger RNA (mRNA) technology. This process provides genetic coded cells needed to produce proteins that stimulate the immune system. It is a novel implication in vaccines; however, this has been used in cancer immunotherapy for years and is rigorously tested.

For more information about the COVID-19 vaccine related to Medicare, contact the experts at Senior Health Medicare today.

Senior Health Medicare is a superior resource for Medicare guidance, information, and ongoing client support. Selecting a Medicare plan is not a flippant decision. It requires annual revisiting and re-evaluating in order for the client to stay in the most cost-effective coverage. Senior Health Medicare is here to serve as your resource through all the years to come. Contact us today at 888-404-5049 or visit us on the web at www.seniorhealthmedicare.com.

Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.

Are Pharmaceuticals in Drinking Water a Health Risk?

In 2008, the Associated Press (AP) conducted a five-month investigation and published a three-part series documenting a wide array of pharmaceuticals (antibiotics, anti-convulsants, mood stabilizers, and sex hormones) that were present in the drinking water of at least 41 million Americans. The concentrations were minuscule but left scientists concerned.

How do pharmaceuticals end up in our water? When people take medicine, some gets absorbed by the body; what doesn’t gets flushed out through our urinary tract, ending up in our sewage systems. Moreover, leftover drugs are oftentimes flushed down the toilet in full-form and eventually into our water supply.

Treatment facilities are not required to test for pharmaceuticals or filter them out. The AP National Investigative Team sorted through hundreds of scientific reports, meticulously filtered through federal drinking water databases, visited environmental study sites and treatment plants, interviewing over 230 officials, scientists, and professors. The largest 50 cities in the United States, along with another dozen other major smaller communities, were surveyed in the study as well.

“You have to drink water. And bottled water isn’t any better than tap water,” said Dr. David Carpenter, director of the Institute for Health and the Environment at the State University of New York at Albany. He said most tap water treatments do not filter pharmaceuticals; however, activated charcoal filters remove most chemical compounds.

Since 2008, little research or information has been published regarding this issue. Follow-up articles are virtually non-existent from the press. Despite the overwhelming silence, several scientific reports have examined the human health risk of drinking pharmaceutical-laced water.

Surface water, groundwater, and drinking water across the United States are tainted with pharmaceuticals from discharges from wastewater treatment plants, septic systems, leaking sewer lines, landfills, animal feeding operations, and crop fields where biosolids are used.

Seven human health risk assessments of pharmaceuticals in drinking water throughout the United States and Canada were reviewed by the American Council on Science and Health. “None of these studies reported a potential health risk from exposure to pharmaceuticals in drinking water,” the site said.

The World Health Organization (WHO) also conducted a study, reporting that the ratio of pharmaceuticals in drinking water is so minimal that they pose a low risk to human health.  “Concerns over pharmaceuticals in drinking water should not divert water suppliers and regulators from other priorities for drinking water and health, most notably microbial risks such as bacterial, viral, and protozoan pathogens, and other chemical risks, such as naturally-occurring arsenic and excessive levels of fluoride,” the article states. The site also explains that pharmaceuticals in drinking water are an emerging issue, so the WHO will continue to examine studies as applicable and update the guidance provided when necessary.

Reynolds Water Conditioning was established in 1931 and is Michigan’s oldest water conditioning treatment company. Still owned and operated by the Reynolds family, we take pride in offering the highest quality products at a cost-effective price. If your tap water lacks the quality you deserve, contact us today at www.reynoldswater.com or call 800-572-9575.

Age-Related Macular Degeneration Linked to Air Pollution

The University College of London revealed their study findings that showed a link between air pollution and a heightened risk of Age-Related Macular Degeneration (AMD.)

The most polluted areas tested in the study were at least eight percent more likely to report people having AMD. The leading cause of irreversible blindness among people over 50 in high-income countries is AMD. The projected amount of people affected by 2040 is 300 million. Some risk factors include old age, smoking, and genetic composition.

Brain conditions such as Alzheimer’s disease, Parkinson’s disease, and strokes have been implicated in those who breathe poor air conditions as well. In 2019, a study found air pollution was linked to an elevated glaucoma risk.

Professor Paul Foster, a lead author of the UCL Institute of Ophthalmology study, said, “Here we have identified yet another health risk posed by air pollution, strengthening the evidence that improving the air we breathe should be a key public health priority. Our findings suggest that living in an area with polluted air, particularly fine particulate matter, or combustion-related particles that come from road traffic, could contribute to eye disease. Even relatively low exposure to air pollution appears to impact the risk of AMD, suggesting that air pollution is an important modifiable risk factor affecting risk of eye disease for a very large number of people.”

The research was conducted with participants who were asked to report any formal doctor-diagnosed AMD. Structural changes in the thickness and/or numbers of light receptors in the retina were assessed in the participants using retinal imaging.

People in areas with high levels of fine particulate matter pollution were higher on the AMD scale. Even after taking other factors such as underlying health conditions and lifestyle, air pollutants (except coarse particulates) were associated with retinal structure changes. 

Though the study cannot confirm cause, as cautioned by the researchers, their findings align with evidence found worldwide. Ambient air pollution might be a culprit, through oxidative stress or inflammation.

Dr. Sharon Chua, of the UCL Institute of Opthamology, said, “Higher exposure to air pollution was also associated with structural features of AMD. This may indicate that higher levels of air pollution may cause the cells to be more vulnerable to adverse changes and increase the risk of AMD.”

If you have AMD or need a professional ophthalmologic evaluation, contact the office of Rohr Eye & Laser Center today.

Rohr Eye & Laser Center offers the most advanced technology available to provide personalized and extraordinary care to our patients. Whether your goal is to maintain or improve your natural vision, we are here to help you. Call us at 877-579-0202 or visit https://www.michiganlasik.com/ to schedule an appointment today.

Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.