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https://labusinessjournal.com/healthcare/sprintray-device-gets-fda-nod/ SprintRay Device Gets FDA Nod - Los Angeles Business Journal Glassell Park-based SprintRay gets the green light from the U.S. Food and Drug Administration to 3D print porcelain crowns. los angeles business gets fda sprintray device nod 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.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.medtechdive.com/news/Medtronic-diabetes-InPen-FDA-clearance-Simplera/733765/ Medtronic nets FDA nod for smart insulin pen app | MedTech Dive The clearance paves the way for the launch of Medtronic’s Smart MDI system, which combines its InPen and Simplera continuous glucose monitor for people who... fda nod insulin pen medtronic nets smart 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.indiapharmaoutlook.com/news/lupin-secures-us-fda-nod-for-ipratropium-bromide-nasal-solution-anda-nwid-3053.html Lupin Secures US FDA Nod for Ipratropium Bromide Nasal Solution ANDA Global pharmaceutical giant Lupin Limited has revealed that it has gained approval from the United States Food and Drug Administration (U.S. FDA) for its... secures us fda nod nasal solution lupin bromide https://www.medtechdive.com/news/stent-to-seal-coronary-artery-perforations-gets-fda-nod/532438/ Stent to seal coronary artery perforations gets FDA nod | MedTech Dive Biotronik's device is the first treatment for the potentially life-threatening emergency in 17 years. coronary artery gets fda stent seal nod https://www.medtechdive.com/news/fda-nod-in-sight-insulets-omnipod-5-boosts-time-in-range-in-diabetes-subs/602534/ FDA nod in sight, Insulet's Omnipod 5 boosts time in range in diabetes subset | MedTech Dive The trial results show improved health outcomes in a crucial patient population for the company: individuals requiring multiple daily injections of insulin. fda nod sight insulet omnipod boosts https://www.medtechdive.com/news/zimmer-smart-knee-fda-nod-de-novo/605833/ Zimmer 'smart knee' gets FDA nod as ortho rivalry with Stryker heats up | MedTech Dive The orthopaedics device maker, through a collaboration with Canary Medical, becomes the first company to bring an implantable smart device for total knee... gets fda zimmer smart knee nod https://www.medtechdive.com/news/terumo-subsidiary-gains-fda-nod-for-aneurysm-flow-diverter/569824/ Terumo subsidiary gains FDA nod for aneurysm flow diverter | MedTech Dive fda nod terumo subsidiary gains aneurysm https://www.medtechdive.com/news/vdyne-fda-ide-approval-tricuspid-valve-replacement/816750/ VDyne secures FDA nod to start pivotal trial for tricuspid valve | MedTech Dive With approval to study the transcatheter replacement device in patients with severe tricuspid regurgitation, VDyne is advancing a treatment to compete with... fda nod tricuspid valve secures start pivotal 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.medtechdive.com/news/extragenital-tests-for-chlamydia-and-gonorrhea-get-fda-nod/555510/ Extragenital tests for chlamydia and gonorrhea get FDA nod | MedTech Dive The products from Hologic and Cepheid are the first authorized to test samples from the throat and rectum, methods that could help more people get screened and... fda nod tests chlamydia gonorrhea get 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.medtechdive.com/news/channel-medsystems-endometrial-cryoablation-device-gets-fda-nod/551805/ Channel Medsystems' endometrial cryoablation device gets FDA nod | MedTech Dive The procedure, indicated for women with excessive menstrual bleeding due to benign causes, can be performed in a gynecologist's office and does not require... gets fda channel endometrial device nod https://www.medtechdive.com/news/avingers-image-guided-device-for-pad-gets-fda-nod/552511/ Avinger's image-guided device for PAD gets FDA nod | MedTech Dive The new device is designed to help physicians remove plaque from smaller arteries and builds on the company's technology that produces real-time images from... image guided gets fda device pad nod https://www.medtechdive.com/news/siemens-latest-15t-mri-scanner-gets-fda-nod/539311/ Siemens' latest 1.5T MRI scanner gets FDA nod | MedTech Dive An increased focus on early disease diagnosis is helping drive rapid growth in the global MRI market. gets fda siemens latest mri scanner https://www.medtechdive.com/news/guardant-companion-diagnostic-gets-fda-nod-as-1st-liquid-biopsy-with-ngs/583198/ Guardant companion diagnostic gets FDA nod as 1st liquid biopsy with NGS | MedTech Dive Cowen analysts noted Guardant360 will be reimbursed under an existing Medicare national coverage determination for genetic profiling using next-generation... gets fda liquid biopsy guardant companion diagnostic 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.edgen.tech/news/post/hbm-holdings-gets-fda-nod-for-phase-1-cancer-antibody-trial HBM Holdings Gets FDA Nod for Phase 1 Cancer Antibody Trial May 8, 2026 - HBM Holdings announced it has received FDA approval to begin a Phase 1 clinical trial for its HBM7004 bispecific antibody in patients with advanced solid... gets fda hbm holdings nod phase https://www.medtechdive.com/news/thermo-fisher-gets-fda-nod-for-plazomicin-immunoassay/544069/ Thermo Fisher gets FDA nod for plazomicin immunoassay | MedTech Dive The antibiotic, marketed as Zemdri, is used to treat patients with complicated urinary tract infections. thermo fisher gets fda nod immunoassay medtech https://www.medtechdive.com/news/Abbott-ABT-test-concussion-TBI/644448/ Abbott gets FDA nod on lab blood test for concussion | MedTech Dive Results are available in about 18 minutes and can rule out the need for a CT scan if negative, the company said. gets fda blood test abbott nod lab https://www.medtechdive.com/news/contura-nabs-fda-nod-for-female-incontinence-device/571631/ Contura nabs FDA nod for female incontinence device | MedTech Dive The London-based company may compete with Allergan, which also sells a bulking agent. fda nod contura nabs female incontinence https://www.medtechdive.com/news/foam-to-stop-abdominal-bleeding-gets-fda-breakthrough-nod/557158/ Foam to stop abdominal bleeding gets FDA breakthrough nod | MedTech Dive Gel-e's Life Foam product is designed to stabilize the patient in battlefield conditions or in a traumatic accident where life-threatening internal bleeding... gets fda foam stop abdominal bleeding https://www.medtechdive.com/news/invitae-test-hereditary-cancer-de-novo-clearance/695468/ Invitae test for hereditary cancers gains FDA de novo nod | MedTech Dive The test analyzes DNA from a single blood sample to identify hundreds of variants in 47 genes associated with predispositions for a range of cancer types. de novo test hereditary cancers gains https://www.medtechdive.com/news/eko-mayo-clinic-heart-failure-screening-fda-breakthrough-device/569401/ AI-based heart failure screening from Eko, Mayo Clinic earns FDA breakthrough nod | MedTech Dive Digital health company Eko is working with the Mayo Clinic on an algorithm to detect reduced left ventricular ejection fraction, an indicator for heart... ai based heart failure mayo clinic fda breakthrough screening https://www.medtechdive.com/news/CMR-Versius-robot-FDA-de-novo-clearance/730149/ CMR Surgical gets FDA de novo nod for Versius robot | MedTech Dive After expanding in global markets, the U.K.-based company will challenge Intuitive Surgical in the U.S., starting with gallbladder removal procedures. gets fda de novo robot medtech cmr surgical https://www.medtechdive.com/news/edwards-Q4-tricuspid-valve-early-fda-approval/706837/ How Edwards’ Evoque valve won an early nod from the FDA | MedTech Dive The heart valve specialist has the chance to shape a new tricuspid market with the first-of-its-kind device, like it did 20 years ago in TAVR, CEO Bernard... evoque valve early nod fda