Latest news with #FluA
Yahoo
4 days ago
- Business
- Yahoo
AMDI Completes Clinical Study for Sub 10-minute Fast PCR System and Secures MDSAP Certification
SANTA ANA, Calif., June 5, 2025 /PRNewswire/ -- Autonomous Medical Devices Incorporated (AMDI), a developer of ultrafast PCR-based diagnostics, announced today the successful completion of its multicenter clinical study supporting FDA submission of its Mini Respiratory Panel. The respiratory panel is the first test developed for its Fast PCR system. In parallel, the company has obtained certification under the Medical Device Single Audit Program (MDSAP), a globally recognized framework for compliance with international quality and safety standards. The Mini Respiratory Panel multicenter clinical study enrolled over 1,900 subjects to evaluate the performance of its ability to detect 4 of the most common respiratory pathogens: Flu A, Flu B, SARS-CoV-2 and RSV. The Fast PCR system is designed for CLIA-waived environments and delivers gold-standard RT-PCR results at the time of care: under 10 minutes. "This dual achievement—completing our clinical study and earning MDSAP certification—represents significant progress on the commercial strategy for the company," said Dave Okrongly, Chief Executive Officer of AMDI. "It's a testament to the AMDI Team, the robustness of our technology, and the quality of the partnerships we have established. We are very excited about the clinical results and remain laser-focused on accelerating access to high-performance diagnostics at the time of care." MDSAP certification, which is accepted by regulators in the United States, Canada, Brazil, Australia, and Japan, demonstrates that AMDI's quality management systems meet the stringent standards required for global market access. The certification was awarded following a comprehensive audit of AMDI's quality management processes, development and manufacturing operations. "Achieving MDSAP certification affirms that AMDI's quality systems meet the highest international benchmarks," stated Aiying Sun, EVP of Quality, Regulatory & Clinical Affairs. "It reinforces our commitment to global compliance and positions us for streamlined regulatory engagement across key markets." AMDI will submit its dual 510(k) and CLIA Waiver application for the Fast PCR system in the 3rd quarter of 2025. The Fast PCR system is the beginning of AMDI's broader vision to deliver rapid, reliable, and scalable molecular testing solutions for infectious diseases and other pressing diagnostic needs. AMDI Media Contact: Brian Millermedia@ View original content to download multimedia: SOURCE Autonomous Medical Devices Incorporated Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Int'l Business Times
29-04-2025
- Health
- Int'l Business Times
RD Support Enlightens The Medical Field On Micro Pumps As The Next Point Of Care Testing Device
When the COVID-19 pandemic hit, much of the world was caught off guard, not just by the virus but by the sheer lack of medical preparedness. In 2020, many healthcare workers in the EU reported a critical shortage of personal protective equipment (PPE). It was a time marked by fear, uncertainty, and urgency, and it revealed deep cracks in the global health infrastructure. Co-founder and director of RD Support , John Arvidsen, believes individuals can't afford to be caught unprepared again. "Frontline workers were risking their lives every day with limited protection and unreliable tools," says Arvidsen. "We were unprepared, and that should never happen again. There will be a next time, and this time, we have the technology to do better." One such innovation is the Micro Pump , a precision-engineered, disposable device designed to integrate seamlessly with lab-on-a-chip (LOC) systems. Developed in 2012 and patented in 2019, the Micro Pump offers a breakthrough in minimizing contamination during diagnostic testing. As Arvidsen puts it, "It's a simple, elegant solution that reduces human handling and keeps everything contained. And that's critical when time, safety, and accuracy matter most." Micro Pump's innovation is in its ability to handle fluids, including blood, saliva, or chemical reagents, within a fully enclosed, self-contained system. It eliminates the need for syringes, tubes, and the manual transfers that too often become points of failure. "You just put your sample in, close the patch, and everything is pumped and analyzed within the cartridge," Arvidsen explains. "No tubes, no extra steps, no risk of cross-contamination. And for a nurse in a high-stress frontline environment, that's a game changer." These pumps are particularly well-suited to LOC systems, micro-scale diagnostic tools that shrink entire laboratory processes onto a chip the size of a credit card. These chips use etched microchannels and sensors to mix, move, and analyze fluids with minimal sample and reagent volumes. Although such types of pumps are already in use for at-home tests for COVID-19, the demand is growing rapidly for more complex medical diagnostics delivered at the point of care. One UK-based diagnostic company, QuantuMDx , partnered with RD Support from concept, through design, and optimization for its SARS-CoV-2 and Flu A/B testing cassettes, scaling production rapidly from concept to pilot manufacturing. Unlike some traditional pumps, RD Support's Micro Pump uses low surface energy polypropylene (plastic), making it ideal for molecular and diagnostic applications. It's engineered for consistent and reliable flow, with configurations ranging from microliters per minute to milliliters per minute. It can be customized or standardized depending on the client's cartridge design. More importantly, it's designed for mass manufacturing. "We know the challenges of taking a medical device from concept to market, taking 8 to 10 years," Arvidsen says. "Our clean room, in-house molding tools, and assembly capabilities allow us to cut that time drastically. We don't just prototype—we build for scale." That end-to-end control means RD Support isn't just a supplier. It's a strategic partner to both established medical device companies and startups alike. "We've been in your shoes," says Arvidsen. "We know what it's like to be on a deadline with an idea that has real potential but no clear path to manufacturing. We help clear that path." Lab-on-a-chip systems and microfluidics are reshaping modern medicine, from personalized drug screening and organ-on-chip modeling to rapid diagnostics in rural or crisis-struck areas. The Micro Pump enhances all of these use cases by ensuring closed-loop, contamination-free handling at a low cost and high volume. Beyond disease diagnostics, the applications are endless: from delivering medicines in controlled doses to PCR testing to moving special oils or biochemical samples in tightly regulated conditions. And with the next global health crisis not a matter of if, but when, Arvidsen believes it's time to invest in scalable, smart solutions now, before lives are at risk again.
Washington Post
25-03-2025
- Health
- Washington Post
When the government becomes a health misinformation superspreader
Kevin Griffis was director of the Centers for Disease Control and Prevention's office of communications from 2022 until last week. Friday was my last day leading communications at the Centers for Disease Control and Prevention. I left my job because I believe public health policy must always be guided by facts and not fantasy. Upon his confirmation last month, Health and Human Services Secretary Robert F. Kennedy Jr. inherited a reformed and revamped CDC. As we moved past the height of the covid-19 pandemic, the agency took stock of its shortcomings and launched initiatives to improve its communications (among other areas), with a particular focus on internal coordination. Our goal was to communicate faster and more clearly. America's federal public health messaging has not always gotten everything right, but health-care providers and the broader public could have confidence that recommendations were made after careful effort to understand and apply the best available science. Consider the case of the Missouri resident who tested positive for avian flu in August. The individual, who had no known exposure to livestock or wild birds, was hospitalized for gastrointestinal symptoms. The patient had a history of chronic respiratory illness. A test in the hospital was positive for Flu A, which was later confirmed to be avian flu. The state then traced everyone the patient could have exposed and who had symptoms around the same time. They turned up six health-care workers and a family member who was also sick. The facts raised a critical question: Were we seeing, for the first time in the United States, human-to-human transmission of a virus that historically kills about half of infected people? The case was complex, but it was vital to convey what we knew — and did not know — about the answer. CDC scientists painstakingly tested the blood of the exposed individuals, using multiple types of assays. The health-care workers tested negative, but the results from the positive individual and the family member were complicated. CDC communicators worked with the agency's infectious-disease experts to prepare materials that told the story of the case. We walked reporters through the details, spending hours answering questions. We also held a call for scientists and livestock health experts across the country to talk through the details with CDC scientists and key leaders. The results of the testing and the epidemiological data gathered about the family members supported a single, common exposure to avian flu and not human-to-human transmission. That meant the CDC's risk assessment for the general public remained low. All this was done to help providers and the public better understand a mystery involving a dangerous virus. It's hard to overstate how different things are today. Now, public health communications have slowed to trickle. The CDC hasn't held a public briefing, despite multiple disease outbreaks, since President Donald Trump's inauguration. Instead of seeking guidance about how to combat the measles outbreak in Texas and New Mexico from the world-leading epidemiologists and virologists he oversees, Kennedy is listening to fringe voices who reinforce his personal beliefs. Kennedy has promoted unproven treatments for measles, such as the antibiotic clarithromycin — a drug that has no effect on viral infections. He also suggested distributing Vitamin A, which does not prevent measles. Meanwhile, in my final weeks at the CDC, I watched as career infectious-disease experts were tasked with spending precious hours searching medical literature in vain for data to support Kennedy's preferred treatments. All this misdirection is a waste of federal dollars that will do nothing to control the outbreak. It also could cost lives. Public health communications should be about empowering people with reliable, science-based information, so they can make their own health decisions. Unfortunately, we can't count on Kennedy's HHS for that anymore. It is painful to say this, given my time in government service, but the United States urgently needs a strong alternative to the government public health guidance it has relied on in the past. I urge public health experts to come together to invest in organizations that provide independent, trustworthy sources of information on vital public health matters. This could take on many forms. But to be successful and durable, it's essential that any such effort foster two-way communication. Without feedback from affected communities, it's harder to know what concerns people have and where information is missing. Also needed are accessible online resources, written in language that's clear and easy to understand. Finally, given how people seek and consume health information, we need coordinated networks of experts, scientists and providers willing to share and amplify accurate information in real time via their social media platforms. In short, the effort needs to match the scope and energy of the entities spreading bad information — including, unfortunately, parts of the U.S. government. My first-hand experience over the recent troubling weeks convinced me thatKennedy and his team are working to bend science to fit their own narratives, rather than allowing facts to guide policy. Let's act now to ensure that the American people continue to have access to reliable, reality-based information they need to protect their health.
Yahoo
17-03-2025
- Health
- Yahoo
10-Year-Old Girl Dies After Flu Complications Left Her ‘Screaming' and Unable to ‘Feel Her Legs and Feet'
A Maryland family is mourning after a 10-year-old girl died from complications of the flu, just days after being dismissed from the hospital. Minka Aisha Greene, a healthy and active elementary school student, was considered the 'light' of her family. So, when the 10-year-old started having low energy and a lack of appetite in late January, her mother Kymesha Greene White was immediately concerned. 'We noticed her behavior changed because she normally doesn't get sick. This was like her first time getting sick,' Kymesha told DC News Now. Kymesha took her little girl to the emergency room and Minka was diagnosed with the flu and a UTI. She was given ibuprofen and sent home to rest. However, Minka started complaining about headaches so her mother took her back to the ER. During the second visit, she was given fluids and sent home again to rest. Minka's health ultimately took a turn for the worse on the morning of Feb. 6, when Kymesha found her daughter vomiting in bed. 'I heard her screaming, 'Mommy!' And I'm like, 'What's wrong?' That's when she said she couldn't feel her legs and her feet,' she recalled. Related: Girl, 9, Dies from Complications from the Flu: 'She Was Too Perfect for This World' Never miss a story — sign up for to stay up-to-date on the best of what PEOPLE has to offer, from celebrity news to compelling human interest stories. Kymesha and her husband David White rushed their daughter, who had not had the flu vaccine, to the hospital. She told the Capitol Heights Daily Voice that on the way there, one of her daughter's eyes rolled to the back of her head and her tongue started moving uncontrollably. Shortly after arriving at the hospital, Minka stopped breathing. Doctors performed CPR and other life-saving procedures but the parents were later told that their daughter had no brain activity. 'That was the last time I carried her, the last time I held her in my arms. I will cherish that for the rest of my life,' said David. Minka later died on Feb. 10 at the hospital. 'We had to let our baby go,' said Kymesha. Following Minka's death, the family learned that she suffered severe brain inflammation caused by the flu. They are now sharing their story in hopes of warning other parents. 'Advocate for your babies,' Kymesha said. 'When they say they're hurting, tell the doctors.' There are two types of influenza viruses: Flu A, and Flu B, according to Verywell Health. They both cause similar symptoms, like fever, body aches, and coughing. While Flu A is more common and thought to be more dangerous — the outlet reports that it accounted for 97% of cases during the 2022-2023 season — Flu B 'symptoms can range from mild to severe.' Additionally, the National Institute of Health reports that 'neurological complications occurred in one-fifth of hospitalized children due to influenza.' The U.S. Centers for Disease Control says, 'Flu can be more dangerous than the common cold for children' and recommends preventative measures — such as vaccination and frequent hand washing. Read the original article on People
Yahoo
06-03-2025
- Health
- Yahoo
Waverly, Ohio teenager on life support after getting the flu
COLUMBUS, Ohio (WCMH) – A Waverly teen is on life support at Nationwide Children's Hospital after complications of the flu. Now, her mother is speaking out about the importance of getting vaccinated and donating blood. A month ago, Jocey Tackett was a healthy 17-year-old girl, enjoying her senior year with friends and looking forward to her future. Now, she's fighting for her life. 'Animals were definitely her passion, and she was super looking forward to, you know, going to college next year and pursuing that degree,' said Renee Tackett, Jocey's mom. Jocey is the middle child; she has an older and younger sister. After high school graduation, Jocey plans on attending Otterbein University to be part of the Zoology program. 'We were supposed to go next month to visit her sister. And Jocey would've had her 18th birthday in Ireland, and now she will most likely spend her 18th birthday in the hospital,' said Renee. On a Sunday in February, Jocey began experiencing flu-like symptoms. By Tuesday, Renee says Jocey just wasn't looking right, so she took her to their local hospital. 'As soon as we got there, she coded,' said Renee. So far, Jocey has spent nearly a month in the cardiac intensive care unit at Nationwide Children's Hospital. While there she tested positive for Flu A and Strep A. 'Her body didn't fight that off and she went septic,' said Renee, 'So it went all through her whole body. So that stopped her heart, and her lungs are completely destroyed.' Since being at Nationwide, Jocey has made some progress. Her heart is now functioning on its own, but her lungs are badly damaged. After watching her daughter code twice and fight for her life, Renee knew she needed to become an advocate for blood donations and vaccines. 'She received, I don't know, exact number, but the nurses tried to figure it out and probably 30 units of blood and about 15 units of platelets and six of plasma. So, without those, again, she wouldn't be here,' she said. One thing Jocey really needed was platelets, which Renee says were not easy to come by. 'Every time I would be so nervous that they weren't going to be able to find the platelets that she needed, and every time they came through,' said Renee. According to Dr. Jason Newland, the Chief of Infectious Diseases at Nationwide, donating blood and platelets is equally as important as getting the vaccine, especially for patients critically ill with the flu. 'When you get very critically ill and land in the intensive care unit with many factors, including just having, you know, just a bad infection that might have a bacterial component to it. Platelets and blood cells, red blood cells can be very, very important for the supportive care that they require,' he said. While we do not know if this contributed to her extreme symptoms, Jocey did not get the flu shot. Her mom said that they never took the flu seriously, until now. If you've been debating getting the flu shot, Renee says to use this as a sign. 'Protect yourself and protect your family, because, I mean, our lives were completely destroyed in a second with no warning,' she said, 'You just don't think anything like this can ever happen. But it's not just my daughter. This is happening. I mean, all over, especially in Ohio.' Dr. Newland says that the community needs to come together and identify why getting the flu shot is important. 'Influenza is a severe disease. It comes quick. And then one might say it can be really, really destructive to people and families in their lives and our preventative strategies have really been focused within the vaccination piece because we know they can be effective against serious disease,' he said. Renee lives roughly an hour and a half away from the hospital, but thanks to the Ronald McDonald House she has had a place to sleep while remaining close to her daughter. She says she's thankful for the staff and volunteers there and grateful for the staff at Nationwide Children's hospital. To find the nearest location offering the flu vaccine near you, click here. If you'd like to donate blood or platelets, click here to find a place near you. If you'd like to support the Tackett family, visit this GoFundMe page. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
