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https://www.medtechdive.com/news/fda-clears-siemens-healthineers-mobile-3d-imaging-arm/541629/ FDA clears Siemens Healthineers mobile 3D imaging arm | MedTech Dive The system is designed to help surgeons work with greater precision and reduce rates of revision surgery as well as the need for follow-up CT scans by... fda clearssiemens healthineersmobileimagingarm https://www.medtechdive.com/news/fda-oks-ngs-test-to-detect-residual-blood-cancer-cells/538489/ FDA clears NGS test to detect residual blood cancer cells | MedTech Dive Adaptive Biotechnologies' assay detects and monitors minimal residual disease in multiple myeloma and B-cell acute lymphoblastic leukemia patients. fda clearsblood cancerngstestdetect https://www.biopharmadive.com/news/leqembi-maintenance-dosing-fda-approval-alzheimers/738365/ FDA clears monthly dosing of Alzheimer’s drug Leqembi | BioPharma Dive The approval is the first to come from the FDA since the Trump administration paused external communication by health agencies last week. fda clearsmonthlydosingdrugbiopharma https://www.biopharmadive.com/news/fda-updated-covid-booster-shot-pfizer-moderna/630776/ FDA clears updated COVID-19 boosters from Pfizer, Moderna | BioPharma Dive The new shots, which are designed to better target circulating strains of omicron, could be available within days. fda clearsupdated covidboosterspfizermoderna https://www.medtechdive.com/news/fda-clears-contego-medical-peripheral-angioplasty-system/543952/ FDA clears Contego Medical peripheral angioplasty system | MedTech Dive The catheter-based device for use in procedures to treat peripheral artery disease incorporates an adjustable filter to capture blood clots and is intended for... fda clearsmedicalperipheralsystemmedtech https://www.medtechdive.com/news/fda-clears-2-endoscopes-that-avoid-reprocessing/600753/ FDA clears 2 endoscopes that avoid reprocessing | MedTech Dive The agency, which has urged a shift to endoscopes with single-use parts or that are fully disposable, gave the OK to UroViu to market a single-use cytoscope... fda clearsendoscopesavoidreprocessingmedtech https://www.medtechdive.com/news/fda-clears-absorbable-foot-and-ankle-implant/546072/ FDA clears absorbable foot and ankle implant | MedTech Dive Ossio said its bioabsorbable orthopaedic fixation implant for foot and ankle conditions, made from a mineral fiber matrix, integrates into the surrounding... fda clearsabsorbablefootankleimplant https://www.medtechdive.com/news/fda-clears-eko-stethoscope-algorithms-for-afib-heart-murmur-screening/571291/ FDA clears Eko's stethoscope algorithms for AFib, heart murmur screening | MedTech Dive The authorization gives primary care physicians an enhanced tool to screen for serious heart conditions, with the aim of speeding diagnosis and treatment. fda clearsekostethoscopealgorithmsafib https://www.medtechdive.com/news/fda-clears-energy-tools-for-transenterix-robotic-surgery-system/546161/ FDA clears energy tools for TransEnterix robotic surgery system | MedTech Dive The company has received FDA 510(k) clearance for a set of advanced energy instruments that can be used with its Senhance robotic surgical system. fda clearsrobotic surgeryenergytoolssystem https://24x7mag.com/standards/fda-updates/clearances/fda-clears-new-neurosurgical-navigation-system-brain-procedures/ FDA Clears New Neurosurgical Navigation System for Brain Procedures May 1, 2026 - Zeta Surgical announced that its Zeta Navigation System, along with the Zeta Stylet and Zeta Bolt instruments, has received FDA clearance. fda clearsnavigation systemnewneurosurgicalbrain https://www.labmedica.com/industry-news/articles/294810241/fda-clears-blood-based-companion-diagnostic-for-advanced-breast-cancer-therapy.html FDA Clears Blood-Based Companion Diagnostic for Advanced Breast Cancer Therapy - Industry News -... May 6, 2026 - FDA Clears Blood-Based Companion Diagnostic for Advanced Breast Cancer Therapy fda clearsbreast cancerbloodbasedcompanion https://aasm.org/fda-clears-kricket-pap-device-with-kpap-from-sleepres/ FDA clears Kricket PAP device with KPAP from SleepRes fda clearspapdevice https://aasm.org/fda-clears-hushd-pro-z-link-oral-appliance-for-sleep-apnea-and-snoring/ FDA clears Hushd Pro Z-Link oral appliance for sleep apnea and snoring fda clearsoral appliancesleep apneaprosnoring https://www.biopharmadive.com/news/fda-clears-modernas-new-covid-vaccine-but-with-limits/749489/ FDA clears Moderna’s new COVID vaccine, but with limits | BioPharma Dive The shot, dubbed mNexspike, is approved for older adults and people whose health conditions put them at higher risk of severe disease. fda clearsnew covidvaccinelimitsbiopharma https://www.medtechdive.com/news/fda-clears-new-version-of-baxter-bone-graft-substitute/531814/ FDA clears new version of Baxter bone graft substitute | MedTech Dive fda clearsnew versionbaxterbonegraft https://www.labmedica.com/fda-clears-ai-digital-pathology-tool-for-breast-cancer-risk-stratification/articles/294810332/fda-clears-ai-digital-pathology-tool-for-breast-cancer-risk-stratification.html FDA Clears AI Digital Pathology Tool for Breast Cancer Risk Stratification - Pathology -... May 7, 2026 - FDA Clears AI Digital Pathology Tool for Breast Cancer Risk Stratification breast cancer riskfda clearsai digitalpathologytool