Seraph® 100 Microbind® Affinity Blood Filter Deemed First-In-Class Medical Device by U.S. FDA Learn more 👉https://lnkd.in/ggaBfMq3 #healthcare #medicaldevices #covid19 #medicalsciences
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Taking advantage of this expanded umbrella designation, I would like to advocate for the Seraph 100 to be investigated for its "probable" clinical utility for the treatment of long-term Post-Acute Sequelae COVID (PASC) and other ME/CFS autoimmune system disorders. Persistent viral infection has long been considered a major driving force in the development of autoimmunity. Recently reviewed by Rattay et. al., "In this review, we discuss virus infections as one of the major causes of autoimmunity, focusing on the role of virus-induced inflammation and deregulated immune reactions". https://lnkd.in/e8cadgTm Given the proven ability of the Seraph 100 to remove not only pathogens but also the likely removal of late apoptotic leukocytes by binding extracellular nucleosomes expressed by these dying cells, the Seraph 100 may help patients clear their elevated levels of these unwanted cells before they significantly trigger detrimental adaptive immune responses and simultaneously tame their autoantibody ANA development. Strong circumstantial evidence suggests the Seraph 100 should be investigated for its potential to remove elevated levels of unwanted dying leukocytes that both PASC and ME/CFS patients are notably suffering from. If true, the Seraph 100 would likely also be ideal for the treatment of multiple autoimmune disorders in which elevated levels of circulating apoptotic leukocytes exacerbate host tissue damage.
Seraph® 100 Microbind® Affinity Blood Filter Deemed First-In-Class Medical Device by U.S. FDA Learn more 👉https://lnkd.in/ggaBfMq3 #healthcare #medicaldevices #covid19 #medicalsciences
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Are you a medical device manufacturer aiming to bring a new sterile medical device to market in the United States? 🇺🇸 Understanding the FDA's 510(k) pre-market notification process is crucial for success. Our latest blog post on 8C Healthcare dives deep into the intricate requirements for submitting a 510(k) pre-market notification for sterile medical devices to the US FDA. From documentation to testing standards, we've got you covered! Read the full article here: https://lnkd.in/e2z_cFE2 Stay ahead in the competitive healthcare landscape with 8C Healthcare's expert insights. #MedicalDeviceInnovation #USFDARegulations #medtechCompliance #MedicalDeviceDevelopment #510kSubmission #SterileDevices #USFDA #CDRH #premarketnotification #8chealthcare
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🔥Regulatory News from Latin America&Caribbean: *AMLAC is the new Regulatory Agency for Medicines and Medical Devices in Latin America and the Caribbean* Subscribe now to read the full story: https://lnkd.in/dUiFxgap #medicaldevices #dispositivosmedicos #dispositifsmedicaux #dispositivimedici #medizinprodukte #regulatoryaffairs
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TGA AUSTRALIA: Regulatory changes for software-based medical devices Version 1.3, June 2024 This guide provides a summary of the recent changes to software-based medical device regulation, effective since 25 February 2021. It highlights transition arrangements for devices that may require reclassification or qualify for an exemption from the Therapeutic Goods (Medical Devices) Regulations 2002. Stay informed and adapt to these regulatory updates. #TGAAustralia #MedicalDevices #RegulatoryChanges #HealthcareIndustry #ComplianceUpdates
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Important topic regarding regulatory changes for software-based medical devices for the Australian market. Our product compliance portal ROGER WILLCO includes the regulatory content and ESSENTIALs regarding the legal obligations for the successful market access of medical devices in Australia (and other third countries). For more information see https://bit.ly/3LasF2e #australia #MedicalDevices #software #ProductCompliance #RegulatoryAffairs
TGA AUSTRALIA: Regulatory changes for software-based medical devices Version 1.3, June 2024 This guide provides a summary of the recent changes to software-based medical device regulation, effective since 25 February 2021. It highlights transition arrangements for devices that may require reclassification or qualify for an exemption from the Therapeutic Goods (Medical Devices) Regulations 2002. Stay informed and adapt to these regulatory updates. #TGAAustralia #MedicalDevices #RegulatoryChanges #HealthcareIndustry #ComplianceUpdates
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📣 The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) has commissioned a study to monitor the availability of medical devices on the EU market. This is your chance to contribute to a significant initiative that could shape the future of healthcare in Europe. The study aims to gather information from manufacturers and authorised representatives, including those planning to place MDR and IVDR compliant devices on the market in the next two years. Your participation will provide valuable insights into the implementation of regulations on medical devices and in vitro diagnostic medical devices. Company-specific information will remain strictly confidential. The aggregated, company-neutral data will be used to create a public dashboard and synopsis reports. Participation is simple and straightforward; its impact can help the industry better responsive to the needs of the market. #MedicalDevices #InVitroDiagnostics #Healthcare #EuropeanCommission #Regulations 1of5 https://lnkd.in/dgEnXVTm
Study supporting the monitoring of availability of medical devices on the EU market Surveys for MD and IVD manufacturers and authorised representatives
ec.europa.eu
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President/Founder | Applied Legal Professional | Rare Disease Advocate | Life Sciences Consultant | KOL | Author
Congress is urging the FDA to reevaluate their policies on medical device recalls, following increased scrutiny as highlighted in the recent article by MD+DI https://lnkd.in/e-v_xrFE As someone passionate about improving patient outcomes, I believe in creating positive processes and frameworks that assist regulatory agencies and legislative policies that are patient-centered. Earlier this year, I had the opportunity to give an oral comment and presentation in two internal listening sessions with the FDA on the impact of in-home use medical devices and gaps in food and drug recalls. Read my personal testimony from the in-home device use listening session here. https://lnkd.in/eN-cfyVr In my opinion, the FDA has taken a proactive approach by proposing solutions and incorporating a patient-centered approach. Let's unite for positive change and continue improving patient outcomes. #PatientOutcomes #FDA #HealthcareImprovement #syngap1 SYNGAP1 Foundation
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CEO @ Qualtivate- consultancy that empowers life sciences to elevate quality management maturity, ensure regulatory compliance, and deploy innovative technology solutions.
Last week, the FDA sent a 477-word letter to medical device manufacturers, reminding them to review 3rd party data. Here are 4 actionable takeaways if you are a sponsor or device manufacturer: --- P.S. What other tips would you add to help sponsors and medical device manufacturers manage third party data?
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One effective way to reduce risk of questionable lab data is to use an ISO 17025 accredited lab and make sure that each of the testing methods the lab is performing for your company are listed on the labs 17025 certification. This ensures a lab specific quality system is in place and the accreditation body has evaluated the lab and each of the tests listed on the labs certification. If the above is missing, it’s probably important to look for an alternative lab for your testing needs.
CEO @ Qualtivate- consultancy that empowers life sciences to elevate quality management maturity, ensure regulatory compliance, and deploy innovative technology solutions.
Last week, the FDA sent a 477-word letter to medical device manufacturers, reminding them to review 3rd party data. Here are 4 actionable takeaways if you are a sponsor or device manufacturer: --- P.S. What other tips would you add to help sponsors and medical device manufacturers manage third party data?
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Despite the best efforts of medical device manufacturers, unforeseen issues may arise, prompting the need for corrective action to mitigate potential risks to patients. One such mechanism for addressing safety concerns is the FDA recall process. Learn more in our latest blog here: https://lnkd.in/dUA5qcYb
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