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https://www.medtechdive.com/news/akura-medical-35m-510k-thrombectomy/695609/ Akura Medical secures $35M to pursue FDA clearance for thrombectomy device | MedTech Dive The money also will help fund clinical trials for additional indications and the expansion of its manufacturing capabilities. device medtech dive fda clearance akura medical secures https://www.medtechdive.com/news/dermasensor-fda-clearance-ai-skin-cancer-detection-device/704857/ Dermasensor wins FDA clearance for AI-enabled skin cancer detection device | MedTech Dive Jan 22, 2024 - A study found the sensitivity of the device was 96%, compared with 83% for primary care physicians. skin cancer detection device medtech dive wins fda ai enabled clearance https://www.medtechdive.com/news/abbott-wins-fda-approval-for-updated-heart-failure-monitoring-device/813453/ Abbott wins FDA approval for updated heart failure monitoring device | MedTech Dive The company redesigned the reader to fit in a carry-on suitcase and be easier to use day to day. wins fda approval device medtech dive heart failure abbott updated https://www.medtechdive.com/news/inquis-raises-funding-pivotal-trial-aventus/732099/ Inquis raises $40M for pivotal trial of clot removal device | MedTech Dive The Aventus thrombectomy system uses technology that tells operators if the device’s tip is in contact with blood, a clot or vessel walls. device medtech dive raises 40m pivotal trial clot https://www.medtechdive.com/topic/cybersecurity/ MedTech and Medical Device Cybersecurity News | MedTech Dive The latest news and updates on medtech and medical device cybersecurity medical device cybersecurity news dive medtech https://www.medtechdive.com/news/pulse-seeks-fda-approval-pfa-clamp/720806/ Pulse drops 510(k) plan for PFA device after FDA requests clinical data | MedTech Dive Analysts said the AFib device is now unlikely to come to market before late 2026. 510 k clinical data medtech dive pulse drops https://www.medtechdive.com/news/device-to-id-obstructions-in-post-pci-patients-wins-breakthrough-status/565734/ Device to ID obstructions in post-PCI patients wins breakthrough status | MedTech Dive Swiss startup CorFlow Therapeutics created the device to both assess and treat microvascular obstruction in patients after percutaneous coronary intervention. medtech dive device id obstructions post https://www.medtechdive.com/topic/recalls/ Medical Device Recalls News | MedTech Dive The latest news and updates on medtech and medical device recalls medical device recalls news medtech dive https://www.medtechdive.com/news/shoulder-device-sales-power-wright-to-beat-and-raise-q3/541726/ Shoulder device sales power Wright to beat-and-raise Q3 | MedTech Dive Strong growth emboldened the company to raise its outlook for the second successive quarter. Jefferies analysts wrote there is "no reason we can see to suggest... device sales medtech dive shoulder power wright https://www.medtechdive.com/news/standards-body-urged-to-add-device-identifiers-to-insurance-claims-forms/568068/ Standards body urged to add device identifiers to insurance claims forms | MedTech Dive Incorporating unique device identifiers into claims documents is expected to improve patient safety and save the healthcare system money by allowing better... standards body device identifiers insurance claims medtech dive urged https://www.medtechdive.com/news/fda-needs-staff-device-recalls-gao/807900/ FDA needs more staff, authority to oversee device recalls, watchdog finds | MedTech Dive “FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk,” the U.S. Government... finds medtech dive fda needs staff authority https://www.medtechdive.com/news/fda-warns-of-medtronic-device-cybersecurity-risk/539530/ FDA warns of Medtronic device cybersecurity risk | MedTech Dive The alert follows discovery that hackers could adjust the settings of cardiac devices. While the FDA has not received reports of patient harm, Medtronic has... fda warns device cybersecurity medtech dive medtronic risk https://www.medtechdive.com/news/mhra-approved-bodies-uk-device-certification/692412/ UK regulators name 3 approved bodies to ease device certification bottleneck | MedTech Dive A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.” name 3 device certification medtech dive uk regulators https://www.medtechdive.com/news/fda-breakthrough-device-final-guidance-health-equity/693781/ FDA finalizes breakthrough device changes to target health inequities | MedTech Dive The proposals received positive feedback from groups including AdvaMed, leading the FDA to finalize the changes with only minor revisions. fda finalizes breakthrough device health inequities medtech dive changes https://www.medtechdive.com/news/heart-device-makers-left-atrial-appendage-closure/702258/ Why heart device makers are investing in left atrial appendage closure | MedTech Dive left atrial appendage heart device medtech dive makers investing https://www.medtechdive.com/news/device-lobby-backs-fda-combo-product-gmp-plan/532577/ Device lobby backs FDA combo product GMP plan | MedTech Dive AdvaMed is pushing to add a section on the annual stability expectations for drug-device products and clarify rules on sampling before finalizing the text. medtech dive device lobby backs fda https://www.medtechdive.com/news/Laborie-465M-deal-buy-Jada-post-childbirth-device-Organon/805097/ Laborie inks $465M deal to buy post-childbirth device from Organon | MedTech Dive Organon tripled sales of the bleeding-control system from 2022 to 2024 and is on track to grow sales again this year. buy post medtech dive laborie inks deal https://www.medtechdive.com/news/mcit-breakthrough-pathway-cures-2-legislation/610174/ MCIT breakthrough device payment pathway included in Cures 2.0 bill | MedTech Dive Lawmakers on Tuesday introduced a revised MCIT proposal in the next version of the 21st Century Cures Act, following last week's repeal of the final rule by... breakthrough device 2 0 medtech dive payment pathway https://www.medtechdive.com/news/fda-approves-pediatric-spine-device-via-humanitarian-pathway/561828/ FDA approves pediatric spine device via humanitarian pathway | MedTech Dive The device is a less invasive alternative to spinal fusion for adolescents with idiopathic scoliosis. fda approves device via medtech dive pediatric spine https://www.medtechdive.com/news/CGM-AI-diabetes-prevention/638050/ AI detects prediabetes in CGM data, opening up new use for device: study | MedTech Dive By correctly identifying many patients with prediabetes or Type 2 diabetes, researchers say CGMs can be used to prevent the disease. ai detects cgm data new use medtech dive prediabetes