smarteeva
@SmarteevaAI
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Smarteeva provides highly adaptable artificial intelligent post-market surveillance tools for the Medical Device industry.
Santa Barbara, CA
Joined January 2018
Daily medtech news with Smarteeva: 21 Nov ☑️ @SiemensHealthineers issues a correction for Tesla MRI systems. A heater-power anomaly triggered a safety-related correction across select MRI units. ☑️ @dexcom to roll out G7 15-Day CGM next month. The extended-wear sensor boosts
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Daily medtech news with Smarteeva: 20 Nov ☑️ @MedularModical files next-gen insulin pump with FDA, eyes 2026 debut. The submission advances the company's simplified, wearable insulin delivery platform toward U.S. clearance. ☑️ @bostonscientific partners with Epic to integrate
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Daily medtech news with Smarteeva: 19 Nov ☑️ @VoltaMedical and @GEHealthCare debut joint EP software in the U.S. The platform enhances AI-driven decision support in electrophysiology procedures. ☑️ FDA clears @LevitaMagnetics Surgical System for pediatric use. Cleveland Clinic
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Daily MedTech News with Smarteeva: 18 Nov ☑️ FDA expands BrainsWay Deep TMS label for adolescent MDD. The decision is backed by real-world evidence from more than 1,100 adolescents treated across U.S. centres. ☑️ Beacon Biosignals secures $86M for AI brain biomarker platform.
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Daily medtech news with Smarteeva: 17 Nov ☑️ @onwdempowered wins FDA clearance for at-home spinal cord stimulation. The expanded indication allows use of the ARC-EX system in home settings for patients requiring spinal cord therapy. ☑️ @bostonscientific, @Siemens partner on 4D
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Daily medtech news with Smarteeva: 14 Nov ☑️ FDA grants label expansion for @BrainsWay Deep TMS to treat MDD. The system is approved for use as an adjunct therapy for adolescents aged 15 to 21 years with major depressive disorder. ☑️ @AbbottNews shared new data supporting its
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Daily medtech news with Smarteeva: 13 Nov ☑️ @biosignals raises $86M to support AI-driven EEG wearable. The Waveband device (previously called the Dreem 3S) directly measures brain activity (EEG) during sleep and awake time. ☑️ @RadNetImaging acquires healthcare management
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Daily medtech news with Smarteeva: 12 Nov ☑️ @Stereotaxis gains FDA clearance for next-gen GenesisX surgical robot. The platform advances precision and automation in robotic magnetic navigation procedures. ☑️ @integra_life received FDA 510(k) clearance for its CUSA aspirator
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Daily medtech news with Smarteeva: 11 Nov ☑️ @lucidmedical advances cell collection tech for early cancer detection. The company’s minimally invasive device helps identify precancerous oesophageal conditions before they progress to cancer. ☑️ @Vexev’s robotic ultrasound meets
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Daily medtech news with Smarteeva: 10 Nov ☑️ @Nitinotes gains CE mark for endoscopic gastroplasty suturing platform. It is an automated suturing platform designed to simplify endoscopic sleeve gastroplasty (ESG) procedures. ☑️ @Snke is preparing to launch SnkeXR, an open
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One platform. Two companies. Two unique paths to smarter compliance. Smarteeva’s Agentic AI fits your strategy, whether you want human oversight or full automation. Read how adaptable AI can transform your processes: https://t.co/WNGO4k0Aj4
#InsightswithSmarteeva #Medtech
smarteeva.com
Discover how Smarteeva empowers MedTech companies to use AI their way adapting to human in loop or full automation for smarter compliance.
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Daily medtech news with Smarteeva: 07 Nov ☑️ @Snke unveils SnkeXR medical-grade AR glasses. SnkeXR provides a medical-grade, open platform that fits into a wide range of medical devices and clinical workflows. ☑️ @ArtivionInc treats the first subject in the trial of the Arcevo
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Daily medtech news with Smarteeva: 06 Nov ☑️ @MicrobotMedical launches Liberty endovascular surgical robot in the U.S.Liberty became the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures. ☑️ @pulsenmore’s at-home ultrasound
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Think the MIT 95% failure rate tells the full story? Smarteeva’s experience with leading MedTech manufacturers shows: AI projects succeed when built into real workflows, not as generic, consultant-designed pilots. Partnering with vertical compliance experts like Smarteeva
smarteeva.com
Smarteeva’s vertical knowledge and tools achieved 98% accuracy within the first production cycle.
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Daily medtech news with Smarteeva: 05 Nov ☑️ @Sonosite launches Sonosite MT portable ultrasound. The new clamshell system enhances mobility and performance for point-of-care imaging. ☑️ @lungpacer enrolls first six patients in next-gen AeroNova neurostim trial. The STARI study
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Daily medtech news with Smarteeva: 04 Nov ☑️ @aqua_endoscopy secures FDA IDE for diabetes-targeted ablation trial. The upcoming study will assess the safety and efficacy of its novel endoscopic ablation therapy for metabolic disease. ☑️ @BDandCo wins FDA clearance and CE mark
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Daily medtech news with Smarteeva: 03 Nov ☑️ FDA clears @InterVene’s in-stent restenosis catheter. InterVene’s Recana is claimed to be the first fully integrated catheter system to address venous in-stent restenosis (ISR). ☑️ @HenrySchein, @AWS partner on AI-powered dentistry.
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Daily medtech news with Smarteeva: 31 Oct ☑️ FDA grants 510(k) clearance to @Sirona_Medical's imaging suite. This move marks the company’s inaugural receipt of Class II medical device status. ☑️ @elucid launches AI software for arterial plaque measurement that quantifies plaque
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Daily medtech news with Smarteeva: 30 Oct ☑️ @ThirdwayvInc and @MedCrypt to enhance medical device cybersecurity. The collaboration will facilitate the provision of secure over-the-air software updates for connected devices. ☑️ @Philips has received a warning letter from FDA,
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Daily medtech news with Smarteeva: 29 Oct ☑️ @JNJMedTech announced new advances in surgical robotic technology with physical AI capabilities, planning to launch in 2026. ☑️ @Philips powers CT-guided PCI shift with new C-arm integration, allowing cath labs to synchronise CT
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