Medical Device
HR25: LifeSignals launches cardiac monitoring patch to compete with iRhythm, Philips
Preventive monitoring, Plaque (lesion), Philips, Heart, iRhythm, LifeSignals, Medical Devices
Former FDA Officials Sound Alarm: Visible Changes May Be Tip of the Iceberg
United States Food and Drug Administration, public health medicine (field), Changing, Vaccines, Leadership, Policy, drug safety, Previous, KAT5 wt Allele, Icebergs, Disease Outbreaks, Alarm device, Visible
Third Harmonic Bio to Liquidate, Selling Key Urticaria Drug Asset THB335
Third Harmonic Bio liquidation , THB335 drug sale , chronic spontaneous urticaria (CSU) , KIT inhibitor , biopharma exit strategy , clinical-stage biotech , shareholder value maximization
Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs
FDA layoffs , Drug review delays , User Fee Programs , PDUFA , Regulatory challenges , FDA budget cuts , Medical device approval , Biopharma regulatory issues , RFK Jr. HHS layoffs , FDA operational disruptions
Dexcom extends G7 sensor wear time to 15 days with latest FDA nod
United States Food and Drug Administration, sensor (device), Continuous glucose monitoring, MSH5 gene, Accurate (qualifier), Extension, wear time, day
Patient suffers side effect in Cabaletta autoimmune CAR-T trial, but analysts unfazed
Systemic Scleroderma, Lupus Erythematosus, Systemic, Cabaletta, cell-associated neurotoxicity, Adverse effects, analysts, Autoimmune Diseases, CAR-T therapy, reSET (device), aspects of adverse effects, Cytokine Release Syndrome
Chiesi unveils 430M investment to revitalize Italian production site for inhaler, biologics manufacturing
Investments, Inhaler, Biological Factors, production
Dexcom survey shows healthcare providers opt for CGM tech over new medications in Type 2 diabetes
Continuous Glucose Monitoring System, Technology, Health Personnel, CGM, Diabetes Mellitus, Non-Insulin-Dependent
Advancing Aseptic Manufacturing: GRAM’s Vision for the Future of Sterile Drug Production
Aseptic manufacturing , Isolator technology, Automation and robotics, Flexible fill-finish capabilities, Advanced drug delivery systems, Regulatory compliance (Annex 1), Strategic partnerships, Patient-centric solutions
Ajax Health and KKR Form New Heart Failure Treatment Platform with Boston Scientific Technology
Ajax Health, KKR, Boston Scientific, FlowMod, heart failure treatment, medical device platform