Smarteeva provides highly adaptable artificial intelligent post-market surveillance tools for the Medical Device industry.
Joined January 2018
- Tweets 3,248
- Following 7
- Followers 68
- Likes 12
1,201 Photos and videos
Jun 11
MedTech news with Smarteeva: 11 June
☑️ @JNJNews expands US availability of an intraocular lens. It designed the extended depth of focus (EDOF) lens to support visual clarity and quality for patients undergoing cataract surgery.
☑️ @KarlStorz gets FDA nod for exoscope for open surgery. It offers the ability to switch into NIR imaging using indocyanine green (ICG) to help reveal important information invisible to the naked eye.
☑️ @DermaSensor wins CE mark for skin cancer detection device. The technology uses hundreds of wavelengths of light in a manner similar to how sonar uses sound.
☑️ @Gore wins CE mark for Fortegra venous stent. It’s the latest addition to the Viabahn device family, engineered to treat patients with deep venous disease.
☑️ @AbbottNews launches next-gen CardioMEMS Hero pulmonary artery pressure reader in US. The CardioMEMS sensor’s design enables it to help people and their physicians proactively manage heart failure.
#InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr
50
Jun 10
100% customer retention. 50,000 users. 4 average years on the platform. 4 in 5 customers expand beyond their first module.
Not one company that started with Smarteeva has left. That is what 100% retention means in practice.
Customers came for complaint management stayed to automate PSURs, MDR submissions, and signal detection. The platform's data model connects each module to the next, so nothing needs to be rebuilt when scope expands.
50,000 users across 80 countries are running post-market surveillance on Smarteeva right now.
#PostMarketSurveillance #MedTech #MedicalDevices #QualityManagement #CustomerSuccess
1
19
Jun 9
An eQMS handles CAPA, audits, change control, training, supplier quality, and complaint handling on the quality side. It is a full quality management system. Saying it 'just stores complaints' is wrong, and we want to correct that.
smarteeva.com/blog/eqms-vs-p…
1
14
Jun 9
A PMS platform handles the post-market half: MDR submissions, PSURs, PMCF, signal detection across device populations. Both touch on complaints. Different parts. The question is whether your two systems are connected.
#PostMarketSurveillance #MedTech #QualityManagement #MedicalDevices #Compliance
smarteeva.com/blog/eqms-vs-p…
14
Jun 4
Manual PSUR: 6 weeks. 3 departments. 100-200 hours.
Automated: 8 minutes.
This month's Smart Pulse breaks down exactly where the manual hours go - plus 3 free PMS tools we just launched (no login required) and a recap of our live agentic AI session at MedTech Forum Stockholm.
Read now: linkedin.com/feed/update/urn…
#MedTech #PostMarketSurveillance #MedicalDevices
linkedin.com/feed/update/urn…
9
Jun 3
Manual PSUR reporting doesn't just take time. It takes weeks of coordination across departments, hundreds of hours of reconciliation, and a review cycle where one correction ripples through everything.
6 weeks. 3 departments. 100-200 hours. For a single report.
Smarteeva changes that to 8 minutes - same data, same compliance, no pivot tables, no re-exports, no chasing records across systems.
Swipe through to see exactly where the manual hours go and how the automated process works differently.
Full breakdown on the blog → smarteeva.com/blog/manual-vs…
#PostMarketSurveillance #MedTech #PSUR #MedicalDevice #Compliance #RegulatoryAffairs
1
1
May 27
Your complaint team spends 1h 52min per complaint. Manually.
We built a free calculator that shows the real annual cost.
200 complaints/month = $322K/year in manual handling.
No login required. Just math.
#ComplaintManagement #MedTech #PostMarketSurveillance #FDA #MedicalDevices #freetool
smarteeva.com/tools?utm_sour…
11
May 26
MedTech news with Smarteeva: 26 May
☑️ @Stryker launches Pangea plating system in Europe, reports first cases. Pangea provides a comprehensive, versatile portfolio of variable-angle plating for a variety of patient populations.
☑️ @Neurovalens earns FDA nod for neuromod for PTSD. This method is known as electrical vestibular system stimulation (VSS).
☑️ @zimmerbiomet gets expanded FDA nod for Rosa robotic shoulder system. The company said it built the updated system on evidence supporting Rosa Shoulder’s accuracy and reproducibility.
☑️ @csrbtx2019 wins CE mark for Sentire endoscopic surgical robot. It combines clinical workflows with integrated engineering, software and imaging technologies.
☑️ @Olympus_Corp to acquire urologic balloon spacer maker BioProtect for $270M. BioProtect develops implant technologies designed to improve prostate cancer care.
#InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr
21
May 21
MedTech news with Smarteeva: 21 May
☑️ @Sentante_robot wins CE mark for endovascular surgical robot. These devices connect to a system equipped with a high-resolution sensory platform capturing the specialist’s hand movements.
☑️ @endologix acquires Pounce thrombectomy system from Surmodics. It comes in multiple configurations to support use across a range of peripheral arterial vessel sizes.
☑️ @Medtronic to acquire peripheral nerve stim developer SPR Therapeutics. The system provides pain relief through a temporary treatment approach, requiring no permanent implant.
☑️ @JNJNews advances intelligent OR network through Abu Dhabi agreement. The collaboration in the UAE launches a global program for developing an open surgical intelligence network.
☑️ @reflowmedical has positive data for coronary drug-eluting stent. The device’s retrievable scaffold therapy creates channels to increase the uptake of antiproliferative drugs.
#InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr
22
May 19
MedTech news with Smarteeva: 19 May
☑️ @dexcom launches Flex CGM for type 2 diabetes in Germany. Flex targets adults with type 2 not on intensive insulin therapy, providing an option for those on basal insulin, oral medications or GLP-1 receptor agonists.
☑️ @Philips introduces SmartIQ imaging tech for Azurion image-guided therapy. It designed SmartIQ to address the trade-off between image quality and radiation exposure for patients and clinical staff.
☑️ @EmStop initiates IDE study of novel embolic protection device. it aims to develop and commercialize the first integrated embolic protection system for TAVR.
☑️ @galvanizetxpeutics wins FDA nod for pulsed electric field generator for surgical ablation.
☑️ @Resmed, @ouraring partner on sleep health education and care. The companies aim to expand access to sleep health education and pathways to care to help people sleep better and improve overall health.
#InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr
75
May 14
MedTech news with Smarteeva: 14 May
☑️ @SiemensHealthineers wins FDA clearance for 6 new interventional imaging systems. It also includes the floor configurations of the Artis Icono.
☑️ @CVRx_Barostim earns Humana Medicare Advantage win for Barostim. Barostim delivers electrical pulses to baroreceptors in the wall of the carotid artery.
☑️ @epineuron wins FDA clearance for nerve stimulator. It also expands the commercial footprint of its proprietary bioelectronic platform for peripheral nerve care.
☑️ @SonoMind raises $23.5M for focused ultrasound-based depression therapy. It says it can now enter the clinical and industrial phases with its technology that targets depression.
☑️ @JNJNews launches next-gen Shockwave IVL catheter. The coronary catheter expands the company’s market-leading IVL portfolio for treating calcified coronary artery disease (CAD).
#InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr
28
May 12
MedTech news with Smarteeva: 12 May
☑️ FDA issues Class I recall correction for @bostonscientific pacemakers. The affected device scope was expanded due to risks of early device replacement when the device enters “Safety Mode.”
☑️ @GlucoTrack submits long-term implantable CBGM for FDA IDE. The company aims to offer it for three years of continuous, accurate blood glucose monitoring for a more convenient, less intrusive solution.
☑️ @Aurie wins FDA nod for reusable intermittent catheter system. It plans to begin commercial efforts with a launch into the Veterans Health Administration spinal cord injury hospitals later this year.
☑️ @histosonics submits Edison histotripsy tech to FDA for kidney tumors. It’s the first and only histotripsy platform cleared for clinical use globally.
☑️ @Biozen wins FDA nod for cuffless blood pressure measurement tech. BP1000 uses the same proven science as an automated cuff, but applies it through the fingertip to measure blood pressure.
#InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr
20
May 12
We're live at @medtecheurope 2026 in Stockholm. Booth 14 is open, the team is ready, and the conversations have already started.
@PlarentY, Jaime Castillo Ayub, and Vinícius Ferrarini Chimello are on the ground showing how post-market surveillance actually works when it's purpose-built and AI-powered.
Later today, Plarent takes the stage for "The Next Frontier in MedTech: Agentic AI for Smarter Post-Market Surveillance" (14:10, Room C4).
➡️ 35% of all FDA MDRs flow through Smarteeva. Come see why.
📍 Booth 14 | Stockholm, Sweden 🗓️ May 11–13, 2026
hashtag#MedTechForum2026 hashtag#PostMarketSurveillance hashtag#MedTech hashtag#AI hashtag#Smarteeva
1
1
25
May 7
Our CEO @Plarent Ymeri is presenting at MedTech Forum 2026, and we're running Smarteeva Orchestra, live AI agents processing complaints and filing regulatory submissions in real time.
If you've ever wondered what "agentic AI in post-market surveillance" looks like in action, this is your session.
Whether you're in Quality, Regulatory, or just curious about what AI can actually do inside a validated environment, come, see it for yourself. We promise it will be exciting!
Can't make the session? We're at Booth 14 all three days (May 11-13) with the same live demo, coffee, and conversations about what's next for your PMS workflow.
📍 Room C4 | May 12 | 14:10 - 15:00
📍 Booth 14 | May 11-13 | Stockholmsmässan
Link in comments ↓
#MedTechForum #AgenticAI #PostMarketSurveillance #MedTech #smarteeva
1
1
1
30
May 6
MedTech news with Smarteeva: 06 May
☑️ @Medtronic wins CE mark for VitalFlow ECMO transport tech. Medtronic’s Transport Frame AG offers a stable, protected, robust way to transport the entire ECMO system.
☑️ @InspireMD recalls CGuard Prime 135 cm stent delivery system in US. Its action has no implications for the safety of patients already with an implanted CGuard stent.
☑️ @Masimo shareholders give green light to $10B acquisition by Danaher. Its technologies include pulse oximeters and healthcare monitoring systems, like the wearable W1 smartwatch.
☑️ @mmimicro_inc completes first robotic-assisted procedure in Alzheimer’s patient. REMIND evaluates microsurgical intervention for neurodegenerative disease.
☑️ @Agitated Solutions wins CE mark for cardiac microbubble generator device. It helps to deliver consistent, clear and bright ultrasound images and more efficient workflows.
#InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr
2
112
May 5
MedTech news with Smarteeva: 05 May
☑️ Insulet @myomnipod initiates study of fully closed-loop insulin delivery in type 2 diabetes. It also helps eliminate settings to start and onboard users.
☑️ @ZetaSurgical earns FDA nod for surgical navigation instruments. The system utilizes computer vision and AI to align preoperative CT or MRI scans with patient anatomy.
☑️ @Sonire kicks off study of focused ultrasound therapy for treating cancer. SUNRISE-II evaluates the Palo Alto, California-based company’s high-intensity focused ultrasound (HIFU) therapy system.
☑️ @Philips gets FDA clearance for flexible MR coil. Its patient-friendly, flexible design aims to deliver robust imaging performance.
☑️ @OrchestraBioMed wins FDA breakthrough nod for pacemaker in hypertension. The patented bioelectronic therapy comes through a standard dual-chamber pacemaker.
#InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr
1
28
Apr 29
MedTech news with Smarteeva: 29 April
☑️ @Medtronic wins FDA nod for next-gen mitral valve. The company reported the first concomitant use of Mosaic Neo with the Penditure left atrial appendage (LAA) exclusion system
☑️ @AbbottNews earns FDA clearance, CE mark for next-gen coronary imaging platform. Ultreon 3.0 is an AI-powered imaging platform that uses optical coherence tomography (OCT).
☑️ @Olympus_Corp wins FDA clearance for Powerseal open extended jaw device. The portfolio offers dissection, grasping and sealing during open and laparoscopic surgical procedures.
☑️ @BDandCo launches new central venous catheter insertion device. The platform also helps reduce contamination risk by minimizing touchpoints and protects against insertion-related complications.
☑️ @CorTec BCI allows patient to control computer with thought alone. Brain Interchange delivers a fully implantable, closed-loop BCI to clinicians to investigate therapies.
#InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr
49