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☑️ Vave Health launches Universal Wireless Probe for full-body imaging. The device offers linear and phased imaging with no recurring fees. ☑️ Bausch + Lomb launches AI-powered Arise lens-fitting system in the US. The intelligent, cloud-based platform streamlines lens fitting for clinicians. ☑️ Monogram Technologies wins FDA 510(k) clearance for robotic knee surgery system. The mBôs system is cleared for total knee arthroplasty (TKA) procedures. ☑️ Hyperfine | AI-Powered Portable MRI partners with NVIDIA to enhance Swoop MRI with AI. The collaboration aims to make portable neuroimaging faster, smarter, and more affordable. ☑️ C2N Diagnostics secures $10m from Samsung. The funding will help scale C2N’s lab services and expand its diagnostic test portfolio. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

☑️ Johnson & Johnson MedTech wins FDA clearance for Monarch Quest robotic-assisted bronchoscopy. The technology enhances navigation for lung procedures. ☑️ Roche Diagnostics USA backs the UK eye cancer AI initiative. Roche’s VENTANA DP 600 pathology scanners support the development of AI solutions for eye cancer detection. ☑️ Valcare Medical wins FDA approval for an early feasibility study of the transcatheter device. The study will enroll up to 15 patients across seven US centers. ☑️ Johnson & Johnson MedTech unveils new orthopedic technologies at AAOS. The company announced multiple regulatory approvals for orthopedic innovations. ☑️ Cognixion launches BCI trial for ALS patients. The study evaluates a wearable AR and BCI system paired with an AI application. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

☑️ Stryker launches next-gen Mako robotic surgery suite. The updated platform enhances precision in orthopedic procedures. ☑️ NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) accelerates FDA submission for nerve ablation technology. The company is moving forward with its regulatory timeline. ☑️ Johnson & Johnson MedTech appoints new electrophysiology and neurovascular chair. Michael Bodner takes on the leadership role at Johnson & Johnson MedTech. ☑️ FDA clears Sooma Medical’s tDCS device trial for depression treatment. The study will enroll 200 subjects across the US in collaboration with Lindus Health. ☑️ FDA approves GT Metabolic Solutions’ 50mm magnet in MagDI System. The incisionless, sutureless technology enables surgical linkage without staples. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

Introducing 𝗦𝗺𝗮𝗿𝘁𝗲𝗲𝘃𝗮𝗔𝗜 𝗣𝗹𝗮𝘁𝗳𝗼𝗿𝗺: a salesforce-integrated solution driven by Fine-Tuned Large Language Model (LLMs) and Retrieval-Augmented Generation (RAG) framework. The SmarteevaAI platform empowers users to choose private, secure LLMs, allowing them to fine-tune models or build RAG frameworks in minutes with no technical expertise required. It automates tasks like data extraction, summarization, and multilingual translation, streamlining workflows for businesses. Read the full PR: https://lnkd.in/gwEp7DmC #AI #Pr #smarteeva #salesforce #finetune #RAG #data #medicaldevice #postmarketsurveillance #complaintsmanagement #recallmanagement #regulatoryreporting

☑️ Merit Medical Systems, Inc. enrolls first subject in Bloom Micro Occluder System trial. The study focuses on patients weighing between 600g and 2.5kg. ☑️ FDA clears Beckman Coulter Life Sciences’s DxC 500i Clinical Analyzer. The device has been available in CE-mark-accepting countries since July 2024. ☑️ Paradromics prepares for BCI clinical study. Investigators have been selected for an upcoming trial on brain-computer interface technology. ☑️ FDA approves Caristo Diagnostics’s AI-powered CAD diagnostic tool. The software assesses coronary plaque severity linked to coronary artery disease. ☑️ Neuromod Devices raises €10m to expand tinnitus treatment device access. The investment is part of an extended Series B round. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

☑️ FDA clears Zimmer Biomet’s revision knee implant component. The implant features a surface-hardening treatment to enhance durability. ☑️ BVI Medical secures $1bn for global expansion. The TPG-backed ophthalmology firm plans to scale operations and launch new products. ☑️ Lungpacer Medical wins FDA IDE for AeroNova system trial. The study will assess AeroNova’s effectiveness in respiratory therapy. ☑️ FDA expands approval for Miach Orthopaedics, Inc. ACL implant. The BEAR implant is now cleared for treating ACL tears in children of any age. ☑️ Medtronic’s TAVR trial shows positive outcomes in small aortic annulus patients. Two-year results confirm superior valve performance. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

☑️ Smiths Medical issues warning on endotracheal tube sizes. ICU Medical’s Smiths Medical warns of potential sizing issues in certain models. ☑️ Stryker’s Inari Medical launches Artix thrombectomy system. The system is designed for arterial thrombectomies. ☑️ Reflow Medical expands its global presence with a new European subsidiary and opens a new office in Germany to boost international growth. ☑️ FDA clears Zimmer Biomet’s Persona Revision SoluTion Femur implant. The revision knee implant received 510(k) clearance for orthopedic applications. ☑️ Capstan Medical’s robotic platform used in first mitral valve replacements. Following a $110M funding boost, Capstan reports successful first-in-human cases. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

☑️ FDA issues early alert for Baxter’s Spectrum infusion pump. Baxter is recalling certain Spectrum infusion pumps due to missing motor mounting screws. ☑️ Cerus secures CE mark approval for LED-based illumination device. Cerus states that the CE mark represents the first regulatory approval for its “next generation” illuminator. ☑️ FDA clears QIAGEN’s QIAstat-Dx Gastrointestinal Panel 2 Mini B. This is the company’s second FDA clearance for a QIAstat-Dx panel this year. ☑️ Vitestro introduces an autonomous robotic device for blood collection. Named after the Netherlands’ first female doctor, Aletta Jacobs, the device is claimed to “optimise” blood draws. ☑️ Inari Medical introduces the Artix thrombectomy system. The new device is Inari’s first product targeting arterial thrombus cases. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

☑️ Medtronic launches an extravascular defibrillator in Japan. Medtronic announced that it launched its Aurora EV-ICD system for treating ventricular arrhythmias in Japan. ☑️ Phantom Neuro’s neural interface wins FDA breakthrough and TAP designations. Phantom Neuro today announced it received FDA breakthrough device designation. ☑️ Vitestro launches Aletta robotic phlebotomy device. Vitestro today launched its Aletta autonomous robotic phlebotomy device (ARPD) that performs automated blood draws. ☑️ Foresight Diagnostics announces trial launch for cHL treatment with ctDNA-based MRD test. The trial will explore end-of-therapy ctDNA-MRD analysis as an exploratory endpoint. ☑️ Exactech announces first Vantage Ankle 3D tibial implants. This week announced the first surgical procedures using its Vantage Ankle 3D and 3D+ tibial implants #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr