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https://www.medtechdive.com/news/device-to-preserve-donor-lungs-wins-fda-approval/553721/ Device to preserve donor lungs wins FDA approval | MedTech Dive The system could expand availability of donor lungs by preserving the organ for up to five hours, giving the transplant team time to reassess marginal lungs... wins fda approval device preserve donor lungs https://www.medtechdive.com/news/noninvasive-magnetic-stimulation-for-ocd-wins-fda-nod/530432/ Noninvasive magnetic stimulation for OCD wins FDA nod | MedTech Dive The agency's clearance for OCD is an extension of a 2008 approval of transcranial magnetic stimulation to treat major depression. wins fda nod magnetic stimulation noninvasive ocd medtech https://www.biopharmadive.com/news/ferring-fda-approval-bladder-cancer-gene-therapy/639078/ Ferring wins FDA approval for bladder cancer gene therapy | BioPharma Dive The OK caps a long development journey for the treatment, which was previously turned back by the agency. Ferring doesn’t expect it to be available until the... wins fda approval bladder cancer gene therapy ferring biopharma https://www.drugdeliverybusiness.com/tandem-fda-clearance-aid-pregnancy-t1d/ Tandem wins FDA nod for AID in pregnancy with type 1 diabetes Tandem Diabetes Care (Nasdaq:TNDM) today announced FDA clearance for its automated insulin delivery technology for use in pregnancy. wins fda nod tandem aid pregnancy type https://www.indianpharmapost.com/drug-approval/adma-biologics-wins-fda-nod-to-expand-asceniv-use-in-young-children-20116 ADMA Biologics wins FDA nod to expand ASCENIV use in young children wins fda nod adma biologics expand use https://www.medtechdive.com/news/Recor-FDA-panel-vote-renal-denervation-Medtronic/691632/ Recor wins FDA panel’s backing for high blood pressure device | MedTech Dive The advisers found the company’s renal denervation system is safe and effective, but several panelists expressed concern about the long-term durability of the... high blood pressure wins fda recor backing device https://www.medtechdive.com/news/abbott-heart-device-for-premature-babies-wins-fda-approval/546051/ Abbott heart device for premature babies wins FDA approval | MedTech Dive The device for sealing a hole in the heart of premature infants is smaller than a pea and can treat newborns weighing as little as 2 pounds. wins fda approval premature babies abbott heart device https://www.biopharmadive.com/news/gsk-fda-advisers-rsv-vaccine-pfizer/644011/ GSK’s RSV vaccine wins FDA panel backing, matching Pfizer | BioPharma Dive Committee members appeared more confident in their recommendation of GSK's shot, with fewer dissents in separate votes on its safety and effectiveness. rsv vaccine wins fda panel backing matching https://www.biopharmadive.com/news/gsks-5-in-1-meningococcal-shot-wins-fda-approval/740144/ GSK’s 5-in-1 meningococcal shot wins FDA approval | BioPharma Dive Feb 18, 2025 - Penmenvy, which protects against five common types of disease-causing bacteria, is cleared for use in people aged 10 through 25 years old. wins fda approval meningococcal shot biopharma dive https://www.biopharmadive.com/news/pfizer-fda-approval-meningococcal-vaccine-penbraya/697441/ Pfizer wins FDA approval of new meningococcal vaccine | BioPharma Dive The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales. wins fda approval meningococcal vaccine pfizer new biopharma https://www.medtechdive.com/news/biomagnetic-imaging-for-chest-pain-wins-fda-clearance/551168/ Biomagnetic imaging for chest pain wins FDA clearance | MedTech Dive The rapid, noninvasive imaging test from Genetesis, a Mason, Ohio-based startup, measures the magnetic fields produced by the heart’s electrical activity. chest pain wins fda imaging clearance medtech https://www.medtechdive.com/news/test-for-parkinsons-wins-fda-breakthrough-designation/555703/ Test for Parkinson's wins FDA breakthrough designation | MedTech Dive Developer Amprion's research focuses on the alpha-synuclein protein as a potential biomarker of the disease. wins fda test parkinson breakthrough designation https://www.medtechdive.com/news/intrathecal-drug-delivery-system-wins-fda-breakthrough-designation/550270/ Intrathecal drug delivery system wins FDA breakthrough designation | MedTech Dive The accelerated review status follows Alcyone's announcement of a strategic collaboration with Roche to develop treatment options for patients with... drug delivery wins fda intrathecal system breakthrough https://www.biopharmadive.com/news/ascendis-fda-approval-yuviwel-achondroplasia-biomarin-voxzogo/813502/ Ascendis wins FDA approval of dwarfism drug | BioPharma Dive Yuviwel, a once-weekly injection, will now compete for market share with BioMarin’s lucrative daily shot Voxzogo. wins fda approval ascendis drug biopharma dive https://www.medtechdive.com/news/cardiva-wins-fda-approval-for-its-vascular-closure-system/544733/ Cardiva wins FDA approval for its vascular closure system | MedTech Dive The Santa Clara, California-based company succeeded in its PMA application and can now market the Vascade MVP device for use in electrophysiology procedures. wins fda approval vascular closure system medtech https://www.medtechdive.com/news/saturated-oxygen-treatment-for-heart-attack-wins-fda-approval/552095/ Saturated oxygen treatment for heart attack wins FDA approval | MedTech Dive The catheter-based device from Irvine, California-based TherOx aims to reduce muscle damage by delivering hyperbaric levels of oxygen to heart tissue. wins fda approval heart attack saturated oxygen treatment https://www.medtechdive.com/news/JNJ-Monarch-FDA-clearance-Nvidia-GE-Healthcare/742370/ J&J’s Monarch robot wins FDA nod for AI software update | MedTech Dive Using Nvidia and GE Healthcare technology, the robotic surgery system is intended to help doctors detect lung cancer earlier. wins fda nod ai software monarch robot update https://www.biopharmadive.com/news/moderna-rsv-vaccine-fda-approval/715544/ Moderna wins FDA approval for RSV vaccine | BioPharma Dive The OK for mResvia adds another option for preventing RSV-related disease in older adults, one year after the agency cleared shots from GSK and Pfizer. wins fda approval rsv vaccine moderna biopharma dive https://www.medtechdive.com/news/medtronic-wins-fda-ok-for-interstim-smart-programmer/544610/ Medtronic wins FDA OK for InterStim smart programmer | MedTech Dive The device giant also got its Navion stent graft system to be included in an aneurysm repair study with Aortica software. wins fda medtronic ok smart programmer https://www.medtechdive.com/news/guardant-fda-approval-Shield-colon-cancer-blood-test/722665/ Guardant wins FDA approval for colon cancer blood test | MedTech Dive Colorectal cancer screening rates could increase if the Shield test appeals to people who have avoided colonoscopies or stool-based tests, the company said. wins fda approval cancer blood test guardant colon medtech https://www.medtechdive.com/news/pulmonary-arterial-hypertension-device-wins-fda-breakthrough-designation/562456/ Pulmonary arterial hypertension device wins FDA breakthrough designation | MedTech Dive Tel Aviv-based SoniVie's device is an ultrasound catheter inserted into the pulmonary artery in a right heart procedure to ablate nerves associated with... wins fda pulmonary arterial hypertension device https://www.biopharmadive.com/news/boehringer-ingelheim-jascayd-fda-approval-idiopathic-pulmonary-fibrosis/802316/ Boehringer Ingelheim drug wins FDA OK in tough-to-treat lung disease | BioPharma Dive The clearance makes Jascayd the first new drug for idiopathic pulmonary fibrosis in over a decade, but some analysts see it as a “modest” advance in care. boehringer ingelheim wins fda lung disease drug ok https://www.medtechdive.com/news/Cleveland-Diagnostics-FDA-approval-prostate-cancer-test/806792/ Cleveland Diagnostics wins FDA nod for prostate cancer test | MedTech Dive The IsoPSA test is intended to help assess whether patients with elevated PSA levels should go on to receive a biopsy procedure. wins fda nod prostate cancer cleveland diagnostics test https://www.medtechdive.com/news/ai-tool-for-cancer-diagnosis-wins-fda-breakthrough-status/550058/ AI tool for cancer diagnosis wins FDA breakthrough status | MedTech Dive Startup Paige.AI, through a licensing agreement with Memorial Sloan Kettering Cancer Center, is developing a portfolio of artificial intelligence-based... ai tool cancer diagnosis wins fda breakthrough status medtech https://www.medtechdive.com/news/Johnson-JJ-FDA-approval-Varipulse-PFA/732277/ J&J wins FDA approval for Varipulse PFA system | MedTech Dive wins fda approval pfa system medtech dive https://www.biopharmadive.com/news/pfizer-rsv-vaccine-fda-approval-abrysvo/651630/ Pfizer’s RSV vaccine wins FDA approval in older adults | BioPharma Dive The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S. wins fda approval rsv vaccine older adults biopharma dive https://www.biopharmadive.com/news/gsk-arexvy-fda-approve-rsv-younger-adults/814652/ GSK’s RSV vaccine wins broader FDA clearance | BioPharma Dive The approval represents a win in what’s been a difficult regulatory environment of late for vaccine makers, and could boost uptake of a shot that’s posted... rsv vaccine fda clearance wins broader biopharma https://pharma-industry-review.com/boehringers-hernexeos-wins-accelerated-fda-nod-in-lung-cancer Boehringer’s HERNEXEOS® Wins Accelerated FDA Nod in Lung Cancer Sep 15, 2025 - In a landmark decision for HER2-mutant lung cancer, the US FDA has granted accelerated approval to Boehringer Ingelheim’s HERNEXEOS® (zongertinib), the... fda nod wins accelerated lung cancer https://www.medicaldesignsourcing.com/senseonics-integrated-cgm-designation-fda/ Senseonics wins integrated CGM designation from FDA, can work with insulin pumps - Medical Design... Apr 30, 2024 - The FDA granted integrated CGM (iCGM) designation to the Eversense continuous glucose monitoring system from Senseonics (NYSE:SENS). With this designation,... insulin pumps wins integrated cgm designation