FemHealth Ventures’ Post

Impact1 Pitch competition winner Neil Ray and the team at Raydiant Oximetry, Inc. are crushing it! 🎉 🙌 They secured the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) for its Lumerah technology, which allowed an early feasibility study on pregnant women during labor and delivery.  Lumerah is a fetal pulse oximeter, measured using an external single-use photonic sensor. The current standard of care, fetal heart rate (CTG) monitoring, has low sensitivity and low specificity for detecting fetal distress. This can lead to unrecognized fetal distress and newborn neurological injury due to oxygen deprivation during birth. Additionally, it can lead to the overuse of emergency C-section deliveries posing risks to both mother and baby. https://lnkd.in/gfr5ajge

🌟 Exciting news in pediatric gastroenterology! Ironwood Pharmaceuticals' #linaclotide, known as #Linzess, is now FDA approved for #children and adolescents aged 6-17 years with functional #constipation. This groundbreaking approval is based on the Phase III study results recently published in The Lancet #Gastroenterology & #Hepatology. Functional constipation, affecting approximately 13% of children globally, presents a significant challenge in pediatric care. Linzess is the first and only prescription therapy approved in this age group for this condition, marking a major milestone in addressing this common yet often challenging issue. As healthcare professionals, we understand the impact of this condition on children's daily lives. This approval offers a new, effective treatment option, potentially improving the quality of life for many young patients and their families. What are your thoughts on this development in #pediatric gastroenterology? Connect, Repost & Follow for more insights on the pharmaceutical industry 🌍 #IronwoodPharmaceuticals #Linzess #FDAApproval #PediatricGastroenterology #FunctionalConstipation #Healthcare #PharmaIndustry #ChildHealth #fda

Congress is in discussion of reauthorizing the FDA's Pediatric Rare Disease Priority Review Voucher (PRV) Program. This program has been crucial in accelerating the development and approval of treatments for rare pediatric conditions, enabling life-saving therapies to reach children in need more swiftly. The PRV program incentivizes pharmaceutical companies to prioritize rare diseases, a critical area of healthcare. With its expiration imminent, prompt congressional action is necessary to sustain this vital program. Reauthorizing the PRV program is essential for maintaining progress in the fight against rare pediatric diseases and improving patient outcomes. #HealthcareInnovation #PediatricCare #RareDiseases #FDA

Remeber there are two patients when treating fetal arrhythmias ❤️ We give some pretty strong drugs to strong mommas for fetal arrhythmias but sometimes we forget to check in with the patient taking the medication. Digoxin, flecanide, and sotalol are the most recommended medications for fetal arrhythmias. Just because they are for the baby doesn’t mean the mom shouldn’t be monitored for all of the same things we would for a non pregnant patient. Some things we need to monitor: Vision changes, chest pain, hypotension, syncope, electrolyte disturbances, arrhythmia of the mother, trough levels, etc. This article does a great job of overviewing treatment recommendations but also highlighting why these may be discontinued. *Pharmacist plug* This is a great place to have a pharmacist help with the management of these medications in an OB patient. https://lnkd.in/g9bBVQXB

The global market for Pediatric Inhalation Chamber was estimated to be worth US$ 960 million in 2023 and is forecast to a readjusted size of US$ 1350.8 million by 2030 with a CAGR of 5.0% during the forecast period 20242030North American market for Pediatric Inhalation Chamber was valued at $ million in 2023 and will reach $ million by 2030 at a CAGR of % during the forecast period of 2024 through 2030. #PediatricInhalationChamber #GlobalMarket #HealthcareInnovation #ChildFriendlyMedication #RespiratoryCare #InhalationTechnology #MarketGrowth #NorthAmericanMarket #EffectiveTreatment #PediatricHealthcare

Neonatal/Pediatric Pharma Pipeline = "Not a Priority" for some. For Innovators, new pharma approaches (less toxic, more targeted,... you name it) are desperately needed. Facts: - the most frequently prescribed medications in neonatology are archaic and include ampicillin, gentamicin, caffeine citrate, poractant alfa, morphine, vancomycin, furosemide, fentanyl, midazolam, and acetaminophen - of the top 50 medications used in infants with extremely low birth weight, only 20 (40%) are FDA-labeled for use in infants; of the 30 that are not labeled for use in infants, 13 (43%) had at least 2 published PK studies -the medications with the greatest relative increase in use from 2010 to 2018 included dexmedetomidine, clonidine, rocuronium, levetiracetam, atropine, and diazoxide If you are an innovator in peds/neonatal pharma space, UCSF's IPD3 (https://www.ipd3.org/) is running a drug discovery pipeline (collaborators are Gates Foundation, DOD...) to help design clinical studies focused on underserved neonatal/pediatric population. https://lnkd.in/gvxFJctx

🌟 Exciting Development in #Asthma Treatment! 🌍 We're thrilled to share that AstraZeneca's Fasenra (benralizumab) has received FDA approval for an additional indication: as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in children aged six to 11. This marks a significant step forward in #pediatric asthma care, extending the benefits of Fasenra beyond its previous approval for patients aged 12 and older. This latest approval was supported by the Phase III TATE study, which confirmed that the pharmacokinetics and pharmacodynamics of Fasenra in young children are consistent with those observed in prior trials in older populations. The safety profile remained robust, aligning with the well-established safety data of the medication. As severe asthma continues to impact the quality of life for many children, this expanded approval offers hope and a new therapeutic option for younger patients and their families dealing with the challenges of eosinophilic asthma. For more information on this groundbreaking treatment and its impact on pediatric asthma management, feel free to connect and discuss how advancements like these are shaping the future of respiratory care. Connect, Repost & Follow for more info on the pharmaceutical industry 🌍 #pharma #pharmaceutical #pediatrics #asthma #respiratoryhealth #healthcare

MediFactories presenting FACTVIEW® LH Ovulation Test Semi-quantitative membrane test for the in-vitro detection of LH (luteinising hormone) in urine. The FACTVIEW® LH is a rapid test for determining human luteinizing Hormone (LH) in urine. When LH is present in the sample, it is bound by specific antibodies immobilized at the test region of the membrane. This complex is then made visible by binding another gold-labelled antibody, resulting in a coloured line. The intensity of the test result line depends on the amount of LH in the urine sample. For more information about us please visit our website https://lnkd.in/dG4VuQEu or just Google www.medifactories.com or connect us at [email protected] or 91-9136013750. We have expertise in the field of - Rapid Test Kits Manufacturing - Urine Test Strips Manufacturing - Respiratory Supplies - Pediatric Supplies - POCT Products #medifactories #medical #pharma #labortaory #labortaoryequipment #rapidtest #urinetest #respiratory #pediatric #healthcare #health #wellness #india #igg #igm #infectodx #medical #medicalequipments #medicaldevices #everythingatfactorycost #lh #oulationkit #firststep

🔎  Learn how Lumos Pharma aims to revolutionize the treatment of rare pediatric growth disorders with Pisit (Duke) Pitukcheewanont MD, FAAP, BCMAS, Lumos Pharma’s Chief Medical Officer. Pediatric growth hormone deficiency (PGHD), for example, impacts 1 in 3,500 to 1 in 10,000 children. 💉 Current treatments involve daily or weekly injections, which can be uncomfortable and lead to missed doses. 🔬 With over 25 years of expertise in growth and bone disorders, Dr. Duke has been instrumental in advancing clinical research. Following successful Phase II results in 2023, a Phase III trial is anticipated later this year. 👉 Discover Dr. Duke's journey and Lumos Pharma’s innovative approach: https://buff.ly/3KddxAH #ClinicalTrials #ClinicalResearch #RareDisease #RareDiseaseClinicalTrials #PediatricRareDisease #PediatricClinicalTrials #XtalksClinicalEdge

Metropolis Healthcare has unveiled the results of a comprehensive three-year study aimed at enhancing #prenatal care and identifying high-risk #pregnancies more accurately. Conducted from January 2021 to December 2023, the study involved 140,528 #pregnant women and explored the efficacy of combining #Pregascreen reflex Testing with Non-invasive Prenatal Testing (NIPT) or #Karyotyping. The findings highlight the transformative impact of integrating advanced prenatal testing methods to better detect #fetal abnormalities and reduce false-positive results. The #study initially identified 5,879 pregnancies as high-risk through traditional early trimester screenings. However, by incorporating NIPT with #Pregascreen reflex testing, the accuracy of identifying genuine high-risk cases improved significantly. In the first trimester, dual marker testing initially flagged 2,416 cases as high-risk. Following NIPT reflex testing, only 64 of these cases remained classified as high-risk, while 1,142 were correctly reassigned as low risk. Similarly, in the second trimester, the Quadruple marker indicated 3,463 cases as high-risk. NIPT reflex testing then accurately reclassified 455 of these as low risk, leaving only 20 still considered high-risk. These results underscore the significant advantages of using NIPT and Pregascreen reflex testing in prenatal screening. The integration of these methods not only reduces false positives but also ensures that high-risk pregnancies are identified with greater precision. This allows healthcare providers to focus their efforts on cases that truly require intensive monitoring and intervention, ultimately improving maternal and foetal health outcomes. Dr. Sushil Shah, Chairman of Metropolis Healthcare, commented on the findings: "Our study demonstrates the critical role of advanced prenatal testing in providing accurate diagnoses and reducing unnecessary anxiety for expectant couples. By leveraging NIPT and Pregascreen reflex testing, we can offer safer, non-invasive, and highly accurate screening options that enhance prenatal care." The study highlights several benefits of this integrated approach: Enhanced Diagnostic Accuracy: By combining Pregascreen and NIPT, the precision in identifying high-risk pregnancies is significantly improved. Non-Invasive Testing: NIPT is a non-invasive procedure, eliminating the risks associated with traditional invasive tests like amniocentesis Increased Accessibility: The advanced diagnostics are made accessible to a broader range of expectant couples, promoting wider adoption and better health outcomes. Looking forward, Metropolis Healthcare is committed to expanding its services and incorporating the latest technological advancements to alleviate maternal health burdens and improve access to innovative healthcare solutions. https://lnkd.in/gsGD6vaC