smarteeva @SmarteevaAI

Daily medtech news with Smarteeva: 01 Oct ☑️ @zenflowinc wins FDA nod for single-use cystoscope. The Spring scope and camera control unit (CCU) received 510(k) clearance for urology procedures. ☑️ FDA approves Zoll Zenix professional monitor/defibrillator. The device received…

Daily medtech news with Smarteeva: 30 Sep ☑️ @FluidAIMedical wins FDA clearance for Origin post-op monitoring device. The real-time system helps track patient recovery after surgery. ☑️ @AngioSafe emerges from stealth with FDA and CE clearance for Santreva-ATK catheter. The…

Daily medtech news with Smarteeva: 29 Sep ☑️ @Philips inks digital health deal with Optum. U.S. Optum members will gain access to Philips’ MCOT and ePatch cardiac monitoring devices. ☑️ @BioLinQ wins FDA de novo clearance for needle-free CGM. The Biolinq Shine wearable…

Daily medtech news with Smarteeva: 26 Sep ☑️ @GEHealthCare brings enterprise imaging SaaS to AWS Marketplace. Its Genesis cloud portfolio is now available directly through AWS. ☑️ FDA flags new safety issue with @JNJNews’s Abiomed Impella controllers. Certain Automated Impella…

The recall process in healthcare has long been fragmented and complex. Healthcare systems and device companies often face delays and missed communications. 𝙎𝙢𝙖𝙧𝙩𝙚𝙚𝙫𝙖 𝙝𝙖𝙨 𝙧𝙚𝙞𝙢𝙖𝙜𝙞𝙣𝙚𝙙 𝙬𝙝𝙖𝙩 𝙞𝙩 𝙨𝙝𝙤𝙪𝙡𝙙 𝙡𝙤𝙤𝙠 𝙡𝙞𝙠𝙚. Introducing the MedTech…

Daily medtech news with Smarteeva: 25 Sep ☑️ @cionicwear secures FDA nod for Neural Sleeve 2. The second-generation mobility sleeve uses AI-driven neuromodulation to support walking in patients with movement disorders. ☑️ @VirtuosoSurg earns FDA breakthrough device designation.…

Daily medtech news with Smarteeva: 24 Sep ☑️ FDA clears @techsomed BioTraceIO360 for kidney ablation planning. The software expands to support percutaneous soft tissue ablation in renal procedures. ☑️ @Picard Medical expands artificial heart IP portfolio. The company secured a…

What if you were the first to know about a medical device recall—every single time? We’ve reimagined recall management from the ground up to give health systems a critical advantage. Curious how it works? The full story is coming soon! Stay tuned. #RecallManagement #HealthTech…

We're Exhibiting at RAPS Convergence 2025! Addressing complex regulatory challenges requires innovative thinking. And, we're excited to connect with the regulatory community in Pittsburgh and invite you to join us at Booth #337 from October 7-9. Explore our streamlined…

Daily medtech news with Smarteeva: 23 Sep ☑️ @FDA withdraws ‘Final Rule’ on classifying LDTs as medical devices. The decision comes after a Texas court struck down the rule earlier in 2025. ☑️ @Transmedics partners with Mercedes-Benz for organ transport in Italy. The…

Daily medtech news with Smarteeva: 22 Sep ☑️ @insight Medbotics debuts Glenn MRI-compatible surgical robot. The system is designed for prostate cancer procedures within MRI suites. ☑️ @AbbottNews issues warning on TactiFlex ablation catheter tip damage risk. FDA notice alerts…

Daily MedTech News with Smarteeva: 19 Sep ☑️ @Siemens Healthineers and Stryker ink neurovascular robotics partnership. The collaboration targets next-gen robotic solutions for stroke and neurovascular care. ☑️ @ImpCare_Stroke reports positive SYMPHONY-PE study outcomes. The…

Daily medtech news with Smarteeva: 18 Sep ☑️ @Baxter launches next-gen Welch Allyn Connex 360 Vital Signs Monitor. The device records patient vitals in under one minute and uploads directly to EMRs. ☑️ @JNJNews launches Shockwave Javelin IVL catheter in Europe. The new catheter…

Daily medtech news with Smarteeva: 17 Sep ☑️ FDA issues correction on @bostonscientific defibrillation lead recall tied to 16 deaths. The defibrillation lead recall remains classified as the most serious type. ☑️ @Medtronic begins pivotal global cardiac pacing study. The trial…

Daily medtech news with Smarteeva: 16 Sep ☑️ @IntuitiveSurg adds real-time insights to the da Vinci 5 robot. The next-gen platform offers 10,000x the computing power of the 2014 da Vinci Xi. ☑️ @BBraun acquires @TDigitalSurgery for microsurgery expansion. The deal strengthens…

⏳ Last chance to register! We are proud to sponsor the 9th Annual Post-Market Surveillance Conference, September 16-17, 2025. Join Plarent Ymeri, CEO of Smarteeva, on September 16! He will deliver real-world insights on the practical application of AI in MedTech, focusing on…

Daily medtech news with Smarteeva: 15 Sep ☑️ Science Corp. launches a patient registry for sight-restoring BCI. The registry aims to expand access to its brain-computer interface technology. ☑️ @smithnephew publishes positive data on Regeneten bioinductive implant. Evidence…

Daily MedTech News with Smarteeva: 12 Sep ☑️ @VedaBioUK, Mammoth Biosciences partner on CRISPR diagnostics. The deal gives VedaBio access to CRISPR IP to accelerate customised diagnostic development. ☑️ @Medtronic signs healthtech co-development deal with Manchester NHS Trust.…

Daily MedTech News with Smarteeva: 11 Sep ☑️ @golifeward wins CE mark for ReWalk 7 personal exoskeleton. The system provides mobility support for people with lower-limb disabilities. ☑️ Sutra Medical completes first-in-human mitral valve repair. Its Sutra Hemi-valve TMVR system…

Daily MedTech News with Smarteeva: 10 Sep ☑️Pulse Biosciences wins FDA IDE for nsPFA AFib study. The trial will evaluate its nanosecond pulsed field ablation system in concurrent cardiac surgeries. ☑️@MicrobotMedical secures FDA clearance for LIBERTY endovascular robot.…