Accelevir Diagnostics’ Post

Are you involved in the medical device sector? Want to stay ahead of the curve with the latest regulatory updates? Then don't miss our upcoming webinar. Industry experts will delve into the recent extensions to the In Vitro Diagnostic Regulation (IVDR) and what they mean for you. Speakers: Dr. Julien Senac, Ph.D., Sue Spencer, and Erik Vollebregt #IVDR #webinar LGC Biosearch Technologies

In this excerpt from Ep9 of Cognition Therapeutics, Inc.'s Conversations, Dr. Honig of Irving Medical Center, Columbia University discusses our #Phase2 #SignalFinding SHIMMER trial-Design&Outcome Measurements #DementiaWithLewyBodies #DLB. $CGTX See the full episode here https://lnkd.in/er2VU5GC

1️⃣ Simpson Interventions has received FDA breakthrough device designation for its Acolyte system, which now qualifies for prioritized review and enhanced feedback from the FDA. 2️⃣ Medtronic's TAVR system demonstrated superior performance in women in the SMART trial, where 87% of participants, typically with smaller aortic annuli, were women. 3️⃣ Roche has earned a breakthrough designation for its Elecsys pTau217 plasma biomarker test for Alzheimer’s, developed in partnership with Eli Lilly, which detects amyloid pathology. 4️⃣ Kalogon has introduced the Orbiter Med, a custom wheelchair cushion that combines its APM system with individualized postural support. 5️⃣ Raydiant Oximetry, Inc. has secured US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) for its Lumerah technology, allowing an early feasibility study on pregnant women during labour and delivery. 🚀 Smarteeva's advanced AI technology, combined with experience and expertise is a game-changer for various medical device companies. Get in touch today: https://lnkd.in/gjYE7UEZ #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

First day of #TIDES2024: insightful talks this morning on the progress from Beam Therapeutics and Prime Medicine, Inc. in base editing and prime editing, respectively.

Cooperation across FONS JK Group, a.s. companies   Crucial Synergies for Lipidica: Lipidica greatly benefits from the deep expertise of our sister companies STAPRO and MeDiLa spol s r.o.   MeDiLa's expertise in 🔬 medical laboratory services complements our effort towards accredited medical lab under ISO 15189 and operating as a clinical laboratory facility.   STAPRO's exceptional track record as a leading supplier of medical and laboratory software 💻 for hospitals and other health care providers in Central European markets will push our medical device software “Lipidica 1.0” for processing data generated by lipidomic analysis in pancreatic cancer screening to the next level. #LipidicaSynergy #MEDILALab #StaproSoftware #HealthcareCollaboration   🌟 We bring together business professionals, clinicians, healthcare experts, payers and regulatory authorities, pushing the technology into clinical practice ultimately serving the greater good of society.

Read about a trial underway for new #drug to treat deadly #BrainTumors, co-authored by MBTI's Karan Dixit, MD: https://lnkd.in/g7ab3aZG. Learn more about MBTI #ClinicalTrials here: https://lnkd.in/g_NExjqe. #BTSM #BrainTumor #Research #CancerResearch #BrainCancer #Clinical #Trials

🧪 #FIPO: launch of the 3rd cohort in the clinical trial The scientific council has given the green light for the third dose in the ascending phase of our FIPO clinical trial. This Phase I/II trial tests the safety and efficacy of XON7 in patients with solid tumors. Key updates: ✅ Safety validated: after cohorts at 1.5 mg/kg and 3 mg/kg, the safety of XON7 has been confirmed. 👩⚕️ New cohort: 3 patients with solid tumors are now being treated at 6 mg/kg across our Foch, Lyon, and Toulouse centers. 📈 Ascending phase: we are progressively increasing doses to ensure safety and assess the benefit/risk ratio of XON7. 💫 Hope for patients: XON7 represents a new hope for patients who have not responded to current treatments. 🔍 More information in our carousel. #ClinicalTrial #XON7 #Biotech #Innovation #PatientCare

🎉 Exciting News from PepGen! 🎉 PepGen has announced positive data from the low-dose cohort of their PGN-EDO51 in the ongoing Phase 2 CONNECT1-EDO51 clinical trial for Duchenne Muscular Dystrophy (DMD)! 🔬 Highlights 🔬 🧬Well Tolerated: PGN-EDO51 at 5 mg/kg was well tolerated, with all patients continuing to the long-term extension phase. 🧬Exon Skipping: Achieved mean exon skipping levels of 2.15% after just 3 months. 🧬Dystrophin Production: A significant increase in muscle-adjusted dystrophin levels, with a mean level of 1.49%, a 0.70% rise from baseline. 🧬Safety: Demonstrated a favorable safety profile, supporting ongoing evaluations. 🧬Their Enhanced Delivery Oligonucleotide (EDO) technology is proving to be a game-changer, delivering higher levels of oligonucleotide to nuclei, indicating stronger potency at lower doses. James McArthur, CEO, stated, "We are encouraged by the early data, which shows PGN-EDO51 produced higher levels of exon skipped transcript at lower doses and in a shorter time period compared to other therapies." #Biotech #DMD #ClinicalTrials #Innovation #PepGen #Healthcare #MedicalResearch #Pharma

🔬✨ Advanced PET/CT systems are transforming #preclinical #research! From tracking tumor progression to studying drug efficacy, these systems offer unparalleled sensitivity and accuracy for the discoveries of tomorrow! Learn more here: https://lnkd.in/gZEkJt-y

☀️ Start your day by catching up on the newest episode of #RewriteTheRules! Rebecca Young, PhD, Sr. Scientist of RNA Sciences at Aldevron, joins us to discuss the benefits of self-amplifying RNA (saRNA) and how R&D and process development teams collaborate together on this new in vitro transcribed RNA. Watch it here 👉 https://sciex.li/8lfn3p #RNA #SelfAmplifyingRNA #Biopharma #VideoPodcast #Vodcast