Mindera Health’s Post

☑️ Lungpacer Medical received FDA premarket approval for its AeroPace neurostimulation system, which is designed to strengthen the diaphragm in patients on mechanical ventilation. ☑️ COPAN Diagnostics, Inc. secures FDA clearance for its urine collection and transport device, simplifying preservation by eliminating precise fill lines and mixing. ☑️ AngioDynamics secures FDA clearance for its NanoKnife system, designed for prostate tissue ablation in intermediate-risk cancer patients. ☑️ SetPoint Medical submits its neuroimmune modulation device for FDA premarket approval (PMA). ☑️ Adaptive Biotechnologies Corp. unveils data from its MRD assessment test, which quantifies malignant DNA sequences in blood cancer treatment. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

Instem has partnered with Proscia, a key player in AI-enhanced pathology solutions, to integrate Instem's Provantis preclinical study management system with Proscia's Concentriq for Research platform. This integration aims to streamline the management of toxicologic pathology and other preclinical studies by enabling faster data analysis, improving collaboration, and ensuring compliance with Good Laboratory Practice (GLP) standards. By combining digital pathology workflows, this collaboration will facilitate quicker and more informed decision-making in both regulated and non-regulated studies. The partnership, which is highlighted at the Society of Toxicologic Pathology's annual symposium, signifies a shared commitment to advancing digital pathology and supporting life sciences organizations in accelerating drug development and clinical trials. Article in full... https://lnkd.in/ednvcdvq

#ICYMI, last week we published exciting data in Science Translational Medicine, representing the culmination of years of hard work here at NMD Pharma. With this recent publication, we are one step closer to achieving a future where people with #NeuromuscularDiseases can improve their muscle strength, power and endurance to live better, more independent lives.   In the video below, our CEO and corresponding author on the paper, Thomas Holm Pedersen, gives insight into NMD670, NMD Pharma’s lead development candidate. This is the first clinical proof-of-mechanism that our ClC-1 inhibitor oral therapy can restore skeletal muscle function in animal models and patients with myasthenia gravis (#MG). Importantly, this new muscle-targeted therapeutic approach has the potential to improve symptoms in other neuromuscular diseases stemming from compromised neurotransmission to skeletal muscles.   Watch the full video here: https://lnkd.in/dec5_-sX #NeuromuscularDisease #Biotech #Innovaiton #RareDisease #Myastheniagravis

There is a new avenue opening in diagnostics and perhaps changing the way we diagnose and monitor disease. While conventional blood profiling continues to be a useful routine analytical procedure, the specific analysis of nanometer-wide extracellular vesicles (EVs) within blood plasma has shown the potential to provide previously undiscovered information on disease pathology. EVs with their specific composition can be considered powerful biomarkers in medical diagnostics. However, EVs need first to be isolated from blood plasma, a major obstacle thwarting this pioneering technology. EV isolation is proving to be a challenge and there is some debate about which method is the most efficient, yet practical. While all methods currently show limitations, the patented technology of Biosynth’s ME™ (Microvesicle Extraction) kit is certainly a contestant technique. The ME™ Kit (urine/media), patent US 8,956,878 https://lnkd.in/eMs6hJsX The ME™ Kit (plasma), patent US 8,956,878 https://lnkd.in/e7iXkCM5 Published data has demonstrated that the ME™ kit can successfully isolate EVs using common lab equipment such as a table-top centrifuge and has already contributed to various research projects. With more convincing data being continuously produced in this field, it is evident that EVs are the future of medical diagnostics. Read our blog exploring why EVs have so much potential in diagnostics while evaluating the success of Biosynth’s EV isolation method, alongside other techniques, in various research papers. https://lnkd.in/ewbgfCvS #extracellularvesicles #EVs #diagnostics #microvesicleextraction #biomarkers #cancerbiomarkers #peptides #Vn96

Idiopathic Pulmonary Fibrosis (IPF) progresses rapidly, making early diagnosis essential for effective treatment. Where traditional tools often fail to detect early-stage IPF, Collagen Hybridizing Peptides bind specifically to denatured collagen, which accumulates as fibrosis progresses. In recent research, CHPs successfully detected fibrosis as early as 7 days after lung injury in mice using PET/CT imaging. Additionally, CHPs distinguished between collagen degradation and accumulation during treatment, providing deeper insights into how therapies may affect fibrotic remodeling. https://lnkd.in/eEqkzXQ7

【Exhaled Breath Vapor of Humans Reflects the Changes in Deuterium Concentration in the Body Water】 Full article: https://lnkd.in/gpE7PjVw (Authored by Gábor Somlyai, et al., from HYD LLC for Cancer Research and Drug Development (Hungary), etc.) The antitumor efficacy of #deuterium (D) depletion, supported by in vitro tests and clinical applications, has gained increasing acceptance. Meanwhile, studies show that the evaluation of the effect of deuterium depletion in healthy, tumorous, and diabetic patients requires a rapid, easy-to-use, and reliable measurement to determine the D concentration and its changes in the body. This study designs and constructs a new medical device for collecting #exhaled_breath_condensate (EBC) samples, and tests its applicability by following the changes in the body’s D concentration while the subjects consumed normal water or #deuterium_depleted_water (DDW). Official submission link-----https://lnkd.in/g5xerrTc

Important new milestone for #Novadip's NVDX3 securing IND approval from the FDA to initiate a phase 2b/3 study in cervical spine fusion. Built upon robust preclinical and clinical datasets, NVDX3 has potential to replace existing allogenic bone grafting materials – providing patients with complex comorbidities better bone fusion success. "The trial will accelerate our capability to bring NVDX3 to patients with complex needs, providing them with a better chance of healing compared to standard-of-care treatments. These strategic steps enable us to take NVDX3 to the next level,” said Denis Dufrane, MD, PhD, CEO of NOVADIP Biosciences S.A. 👉 Read the full release: https://lnkd.in/dUHwjR2F

HORIBA has launched new compact hematology analyzers with combined ESR and CBC/Diff! Yumizen H550 range has expanded to affordably introduce new applications and configurable hematology options for small to mid-throughput laboratories. ✅ Offering combined testing for CBC/5-part WBC Diff with ESR results from whole blood in 60 seconds by HORIBA's patented CoRA technology ✅ i-DoubleDiff technology provides infectious screening (Malaria/Dengue) + normal and abnormal leukocyte count (37 parameters) ✅ Connectable with Yumizen P8000 middleware for data management, and the Yumicare remote technical support tool. ✅ Ideal for routine workload, oncology care, infectious disease care, blood banks, satellite laboratories, health centers, and more. 📌Read more: https://bit.ly/4bu5Wt2 #YumizenH550E #YumizenH500E #Hematology #HematologyLab #ClinicalLab #MedicalLab #LaboratoryTesting #ClinicalTesting #MedicalDiagnosis #

‼️Our paper is published! Check out this interesting #preclinical study of a new #nanocomplex for the #treatment of #cmt1a #disease European CMT Federation Charcot-Marie-Tooth Association AFM-Téléthon CMT-France

At Genedrive, we are committed to advancing #diagnostics to the point of care. That's why our reagents are freeze-dried during manufacture. This means they can be stored at room temperature, with no need for a freezer. Allowing easy access for #healthcare providers to perform genetic tests at the point of care. This is just one of the reasons why NICE recommended the Genedrive CYP2C19 ID Kit! The Genedrive CYP2C19 Kit is a point-of-care pharmacogenetic test to inform clinicians of genetic CYP2C19 metaboliser status, prior to treatment prescription. Read the full RNS: https://lnkd.in/e3_xqt3k #GDR #Stroke #HeartHealth #Cardiology #ThriveAfterStroke #Pharmacogenomics #Pharmacogenetics #Pgxmovement #PointofCare #POCT #Diagnostics #MedTech