ADI Intellect’s Post

"The FDA recommends laboratories...develop strategies to prioritize the use of blood culture media bottles, based on clinical need, to maintain quality and safety of patient care." How do you confidently decide which patient does or doesn't warrant use of the limited supply on hand? Immunexpress Inc. has a quick, affordable #IVD solution to rule in/out sepsis with high sensitivity and specificity, high PPV and NPV. Message me for information - we can help. #sepsis #bloodculture #hostresponse #moleculardiagnostics #diagnosticstewardship #laboratorydiagnostics #clinicaldiagnostics https://lnkd.in/eaQh_4Fp

🥸 Immunexpress Inc. has a quick, affordable #IVD solution to rule in/out #sepsis with high sensitivity and specificity, high PPV and NPV. no pathogen ID necessary! DM me for information on the FDA cleared SeptiCyte RAPID- we can help! #sepsis #infectioncontrol #antimicrobialstewardship #patientcare #laboratorydiagnostics #clinicaldiagnostics #hostresponse #bloodculture

The FDA recently released guidance regarding general principles on planning, designing, and analyzing pharmacoepidemiological studies using real-world data for medicine safety assessment. This is crucial as these studies play a pivotal role in evaluating how medicines benefit and pose risks to children, who are often underrepresented in pre-approval clinical trials. Let's continue to prioritize the health and well-being of children by ensuring thorough and inclusive research practices. Together, we can advance pediatric healthcare and improve outcomes for the next generation! 💙 #PaediatricClinicalTrials #ICON #CenterforPaediatricClinicalDevelopment

#portfolionews I Our portfolio company Xeltis has received Investigational Device Exemption (IDE) approval from FDA - La Administración de Alimentos y Medicamentos for initiation of US pivotal #trial for aXessTM, its restorative vascular access conduit. 👏 👉 Full details here https://bit.ly/4c3uSsf 🎯 aXess is a restorative conduit that enables the creation of a new, permanent, living vessel for #hemodialysis vascular access, combining the #safety and patency of an arteriovenous fistula (AVF), with the speed to treatment of an arteriovenous graft (AVG). The aXess vascular access conduit offers an improved dialysis patient experience and avoids the frequent reinterventions and complications, such as infections, faced by many renal disease patients. 🔬 The #US-based pivotal trial follows strong 12-month data from the first-in-human trial in Europe in comparison to hemodialysis vascular access solutions. aXess is also undergoing an EU pivotal trial, recruiting up to 110 patients in nine #EU countries. #FDA #VascularAccess #IDE #hemodialysis #renal #vc #innovation #MedicalInnovation #Healthcare #RenalCare #FDAApproval #ClinicalTrials 

Happy Thursday to my LinkedIn Network! 🌐 Open question. Are we being a supportive society towards those who really need medications? A Call to Action: Addressing the GLP-1 Medication Shortage 🚨 The European Medicines Agency (EMA) has recently highlighted a concerning shortage of GLP-1 receptor agonists. These medications are not just numbers on a spreadsheet; they are lifelines for patients managing conditions like diabetes. 🩺💊 The shortage poses a significant threat, as those who depend on these treatments face the risk of running out of essential supplies. It’s a stark reminder of the delicate balance between medication production and patient needs. 🔄 As a community, we must rally to ensure continuity of care. We need to amplify the urgency and advocate for solutions that prevent such shortages from disrupting lives. 📢 Patients deserve stability in their treatment plans. Let’s join hands in calling for action and safeguarding the health of those in need. 💪 🔗 https://lnkd.in/d5vms2gr #Healthcare #Pharma #GLP1Shortage #PatientCare #DiabetesManagement

🚨 Urgent Call to Action Against FDA Overreach on Lab Tests 🚨 The FDA's latest proposal to regulate laboratory-developed tests (LDTs) is a direct assault on medical innovation and patient care, threatening to derail critical diagnostic services like our Aristotle test. This overreaching move by the FDA will not only stifle advancements in healthcare but also deprive patients of life-saving diagnostics for rare diseases and emergent health threats. LDTs have historically filled the void left by commercial tests, enabling rapid responses to pandemics and providing essential diagnostics for rare conditions. The proposed regulations are not just burdensome; they're a blockade against the progress and responsiveness our healthcare system critically needs. Theriome's commitment to pioneering diagnostics is at risk. The FDA's broad brush in citing isolated incidents, like Theranos, to justify sweeping regulations ignores the rigorous oversight already in place through CLIA and other accrediting bodies. This isn't about enhancing patient safety; it's regulatory overkill that threatens to bring vital diagnostic innovation to a grinding halt. We must forcefully oppose this regulatory overreach that jeopardizes access to essential tests like the Aristotle test. It's time to demand a regulatory framework that supports, not hinders, healthcare innovation and ensures that diagnostics can advance without unnecessary barriers. Stand with us in advocating for a future where diagnostics remain at the forefront of healthcare, unencumbered by detrimental and misguided FDA policies. #StopFDAOverreach #ProtectHealthInnovation #DiagnosticFreedom #Theriome #HealthcareInnovation

Adverse drug reactions (ADRs) can be identified and prevented by recognizing early warning signs and following best practices for medication management. The article emphasizes the importance of patient education, healthcare provider communication, and regular monitoring to minimize risks associated with medication use. https://lnkd.in/dgXkge9j

"The same expertise that served the nation during the COVID-19 pandemic will be lost under the burden of the new regulatory system." If you are a #physician or a #patient, this affects you. Fantastic arguments from Miller, Watts, & Samuel opposing the FDA's proposed rule for the regulation of LDTs in this recent commentary published in ASM's JCM. Read here: https://lnkd.in/gcFYSVVa

***US FDA approves first treatment for severe frostbite*** The primary measure of efficacy was: - A bone scan obtained seven days after initial frostbite that was used to predict the need for amputation of at least one finger or toe. - On day seven, the need for amputation was observed in none of the 16 patients receiving iloprost alone, compared with 3 of 16 patients and 9 of the 15 patients on medications unapproved for frostbite, given with iloprost or without iloprost. https://lnkd.in/g6ZvX5Qw

https://lnkd.in/gEtjPTeh Key Insights: • ZELSUVMI stands out as the initial and sole topical prescription treatment accessible for application by patients, parents, or caregivers in the convenience of their home, without the need for a physician’s office or another medical setting. It effectively addresses this extremely contagious viral skin infection Visit MedicoInsights to explore key insights #HealthcareNews #drugs #StayInformed #MedicalNews #drugapproval #HealthTrends #Insights #HealthIndustry #HealthInnovation #LigandPharmaceuticals #HealthcareAnalytics #NewsUpdate #HealthcareNetworking #pharma #pharmaceuticals #pharmanews #pharmaindustry #pharmainnovation #update #medicoinsights