smarteeva

MedTech news with Smarteeva: 18 March ☑️ @ReVisionImplant wins FDA breakthrough nod for vision-restoring BCI. Occular interfaces with the brain in an effort to restore functional vision in people with severe blindness. ☑️ @RevolveSurgical wins FDA clearance for surgical robot. It provides robotic assistance to augment surgeons performing soft tissue procedures. ☑️ @PerfuzeStroke wins FDA clearance for standalone aspiration catheter. The company aims to improve stroke treatment outcomes and reduce procedural complexity. ☑️ FDA warns on heart pump purge cassette issue from @JNJMedTech’s Abiomed. It is recommended that customers remove certain Impella Purge Cassettes and Impella RP Pump Sets from where they are used or sold. ☑️ @endogenex has positive data for pulsed electric field tech for diabetes. It utilizes non-thermogenic pulsed electric fields (PEF) to regenerate duodenal mucosal and submucosal cells. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

MedTech news with Smarteeva: 17 March ☑️ @Prodeon gets FDA clearance for BPH-treating nitinol implant. Prodeon designed Urocross for procedures that utilize commercially available cystoscopes. ☑️ @JNJNews wins FDA nod for new intraocular lens. J&J plans to make Tecnis PureSee available for U.S. patients later this year. ☑️ @IntuitiveSurgical discloses cybersecurity breach. It says it quickly activated its incident response protocols and secured all affected applications. ☑️ @Olympus corp launches next-gen surgical imaging platform. The company designed its platform to enhance surgical visualization, workflow efficiency, and multispecialty flexibility ☑️ @PROCEPTRobotics announces international Hydros robot launch. The company says it represents the first AI-enabled robotic platform designed specifically for the treatment of BPH. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

MedTech news with Smarteeva: 11 March ☑️ @CookMedical launches new endoscopy products. The Cold AcuSnare is also available in direct markets in Europe. ☑️ @NoahMedical study backs real-time imaging guidance in robotic bronchoscopy. The study evaluated 3D targeting during RAB procedures using embedded imaging technologies. ☑️ @OncoPatch wins FDA nod for tumor-treating patch device. The technology offers a distinct, patch-based approach to delivering beta radiation directly to skin cancers and superficial lesions ☑️ @CamDiab introduces fully closed-loop automated insulin delivery tech. It pauses the need to count carbohydrates or deliver meal boluses, fully automating insulin delivery. ☑️ @KARLSTORZ_FI wins FDA nod for single-use bronchoscope. The company says its new device offers a valuable new option for critical care physicians, intensivists, RTs and ICU-based proceduralists. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

MedTech news with Smarteeva: 10 Mar ☑️ @StrykerEndo launches SmartHospital platform to elevate care delivery. It aims to connect devices, data and care teams across the hospital. ☑️ @Pulse_Bio has positive data for thyroid nodule ablation. It evaluated the ablation of benign thyroid nodules using nanosecond pulsed field ablation (nsPFA) energy. ☑️ @BDandCo received CE mark for Revello vascular covered stent. Revello features an ultra-thin, expanded polytetrafluoroethylene covering. ☑️ @GEHealthCare earns FDA 510(k) clearance for next-gen diagnostic viewers. View is a cloud-native software application designed to support healthcare professionals in the display, processing and analysis of medical image data and clinical reports. ☑️ @Philips gets FDA nod for AI-powered SmartHeart cardiac planning tech. SmartHeart, an AI-powered cardiac magnetic resonance (MR) planning solution, aims to simplify one of the most demanding MRI exams. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

Manual complaint intake doesn't scale. 18,400 complaints per year × 1h 52m each = 34,453 hours of manual work. Smarteeva automates what shouldn't require human effort: → Complaint intake in 3 minutes → AI-powered triage and duplicate detection → Auto-generated follow-ups → Complete audit trails See the full cost breakdown in the slides. ➡️ #MedTech #QualityManagement #RegulatoryCompliance #smarteeva #ROI #fda #complaintintake #MDR #MIR #CVR #recall #Adverseevents #productregistration #PMS #QMS

MedTech news with Smarteeva: 05 March ☑️ @Philips unveils Rembra next-gen radiology CT system. It features advanced detector technology, ultra-fast scan and reconstruction speeds and streamlined workflows. ☑️ @BDandCo received CE mark for Revello vascular covered stent. Revello features an ultra-thin, expanded polytetrafluoroethylene covering. ☑️ @TandemDiabetes Care launches Mobi pump on Android phones. The pump, which pairs with Tandem’s Control-IQ+ algorithm, previously worked with iOS software ☑️ @StrykerEndo highlights new additions to Mako, Triathlon portfolios at AAOS. It delivers fixation and long-term durability with scratch resistance superior to competitive surfaces. ☑️ @JNJMedTech launches new CereGlide aspiration catheters in the US. The medtech giant also launched the InnerGlide 7 delivery aid, rounding out the newest additions to its aspiration-first stroke portfolio. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

MedTech news with Smarteeva: 03 March ☑️ @senseonics earns FDA IDE for next-gen Gemini CGM, posts Q4 revenue beat. It enrolled the first patients in the IDE trial and expects to complete that in the second half of 2026. ☑️ @bostonscientific wins expanded CE mark for Farapulse in persistent AFib. Farapulse, a nonthermal PFA treatment, uses electric fields to selectively ablate heart tissue. ☑️ @AbbottNews earns FDA green light for next-gen CardioMEMS pulmonary artery pressure reader. It represents a new component of the company’s CardioMEMS HF system. ☑️ @synergyspine gets FDA nod for cervical disc. It treats patients with degenerative disc disease (DDD) of the cervical spine. ☑️ @HighridgeMedical begins limited rollout of activL lumbar disc. As part of the launch, Highridge partnered with leading arthroplasty surgeons to support early adoption of activL. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

MedTech news with Smarteeva: 25 Feb ☑️ @StrykerEndo launches next-gen syndesmotic fixation device for ankle stabilization. They designed Synchfix EVT to simplify surgical deployment while supporting ankle stabilization in patients with syndesmotic disruptions. ☑️ @HaemoneticsCorp gets FDA nod for next-gen plasma collection system. Its platform tailors plasma collection to each donor for improved average plasma volume per donation. ☑️ @Brainomix extends Series C to $25.4M for AI stroke imaging tech. Powered by state-of-the-art AI algorithms, 360 Stroke provides real-time interpretations of brain scans. ☑️ @RecorMedical also secures renal denervation reimbursement in Japan. Paradise is included in the same Central Social Insurance Medical Council General schedule as Symplicity. ☑️ @Olympus_Corp announced FDA clearance for pediatric use for two of the single-use bronchoscopes it distributes in the U.S. The portable, 12.1-inch monitor allows for ease of care in critical or emergent situations. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

Daily medtech news with Smarteeva: 24 Feb ☑️ @InVeraMedical wins European approval for vein infusion device. The InVera device differs from existing technologies that use thermal ablation, employing a non-thermal approach. ☑️ @prosomnus raises $38M for CPAP alternative. With the investment, it plans to advance the development of next-generation remote patient monitoring and proprietary sleep diagnostic devices. ☑️ @alluriontech announced FDA premarket approval (PMA) for its Allurion Gastric Balloon System. The swallowable system requires no surgery, endoscopy or anesthesia. ☑️ @BIOTRONIK_US wins FDA nod for pacing lead for left bundle branch area pacing (LBBAP). Biotronik designed its system with an optimized helix, enhanced steerability and simplified handling. ☑️ @W.L. Gore & Associates announced the completed acquisition of @conformalmed. The company aims to simplify delivery and eliminate the need for procedural transesophageal echocardiogram (TEE). #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

MedTech news with Smarteeva: 18 Feb ☑️ @PortalDiabetes earns FDA breakthrough nod for implantable insulin pump. It aims to deliver a functional cure for type 1 diabetes. ☑️ @GEHealthCare, @BARDA ink $35M AI-powered ultrasound expansion. The expanded scope aims to facilitate the development of several new AI-powered tools. ☑️ @lsmcentre, @i-SENS partner to launch CGM platform. It aims to provide simplicity, accuracy and trust in diabetes management. ☑️ @neurentmedical raises $74M to accelerate chronic rhinitis treatment launch. Neuromark features a flexible shaft and atraumatic leaflets that conform to the patient's anatomy. ☑️ @zimmerbiomet, @P28Ia announce commercial launch of curved TTC nail system. The Phantom Curved TTC nail system follows the anatomic arc of the foot. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

MedTech news with Smarteeva: 17 Feb ☑️ @Philips introduces a flexible pediatric MRI coil. It features a light, blanket-like design and a soft, flexible structure, gently wrapping around the patient. ☑️ @encorajobs wins FDA clearance for wearable devices for its Encora X1 device. The X1 device is worn on the wrist to treat essential tremor. ☑️ @Resmed launches AirTouch F30i Comfort full-face fabric mask. ResMed said it designed the new mask to help more people start and stay on CPAP therapy. ☑️ @ProfusaInc, @MayoClinic collab on oxygen monitoring tech. It said the collaboration intends to investigate the clinical applications of its oxygen-monitoring technologies for new product development and commercialisation. ☑️ @Medtronic wins FDA nod for surgical robot for spine procedures. It received clearance for spine procedures in the U.S. and has an underlying architecture designed to support future cranial and ENT applications. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

@nextsense_io Good luck with the launch 🥳

@SmarteevaAI Thank you for spreading the word about our launch! 🎉

Daily medtech news with Smarteeva: 11 Feb ☑️ @StrykerEndo introduces Mako Handheld Robotics with Mako RPS launch. It says the new platform represents Mako’s expansion into a new robotics platform. ☑️ @zimmerbiomet gets FDA nod for newest addition to G7 hip implant line. It features Rim Fix screws and perimeter holes designed to provide multiple points of access and engagement to help surgeons achieve stable fixation in compromised bone. ☑️ @BetaBionics receives FDA warning letter. The FDA outlined deficiencies in the automated insulin delivery system maker’s response letters. ☑️ @SNSUniofGalway launches medtech prototype hub through @Medtronic partnership. The partnership focuses on three pillars: developing the medtech ecosystem, STEM engagement and research. ☑️ @nextsense_io debuts brain activity-sensing headphones to improve sleep. It measures real-time electrical activity in the brain and responds with audio stimulation to guide users into deeper sleep. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

Daily medtech news with Smarteeva: 10 Feb ☑️ FDA clears @MEDIANTechno lung nodule evaluation software. Median's eyonis LCS is reimbursable under Medicare at a rate between $601 and $700. ☑️ @Sonorous receives FDA breakthrough designation for BosSTENT device. The device is designed to address limitations in current treatment options for patients with this condition. ☑️ FDA classifies @JNJMedTech's CEREPAK recall as Class I following patient death. A fault in detachable coils, used in intracranial aneurysm embolisation procedures, has been associated. ☑️ @GEHealthCare and @Diagnoly integrate AI solutions for foetal ultrasound. Fetoly is a real-time AI solution providing standardised foetal ultrasound examinations in accordance with ISUOG guidelines. ☑️ FDA grants clearance for Eyas Medical Imaging’s neonatal MRI system. It is a device engineered specifically for the anatomy of neonates and infants. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

Daily medtech news with Smarteeva: 04 Feb ☑️ FDA clears @RevealDX’s AI lung nodule diagnostic. Their software analyses CT scans and assigns lung nodules with a Malignancy Similarity Index score to aid in lung cancer diagnosis. ☑️ @AbbottNews receives FDA warning letter related to FreeStyle Libre CGMs. The sensor for the next-generation FreeStyle Libre 3 CGM is the same size as two U.S. pennies stacked together. ☑️ @JNJMedTech's Abiomed warns of potential sensor malfunction in certain Impella devices. Abiomed identified that the differential pressure (dP) sensor in Impella RP devices may malfunction. ☑️ @Medtronic expands its cath lab portfolio with @CathWorks acquisition. The medtech giant agreed to invest up to $75 million. ☑️ @QuestDX launches flow cytometry MRD test for myeloma. Quest expects the new blood test to support response monitoring in clinical trials. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

New Launch ⚠️ 𝗪𝗲’𝘃𝗲 𝗹𝗮𝘂𝗻𝗰𝗵𝗲𝗱 Smarteeva 𝗢𝗿𝗰𝗵𝗲𝘀𝘁𝗿𝗮™️ - 𝗮𝗻 𝗔𝗜 𝗮𝗴𝗲𝗻𝘁 𝗯𝘂𝗶𝗹𝗱𝗲𝗿 𝗳𝗼𝗿 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘁𝗲𝗮𝗺𝘀. 𝗪𝗶𝘁𝗵 𝗦𝗺𝗮𝗿𝘁𝗲𝗲𝘃𝗮 𝗢𝗿𝗰𝗵𝗲𝘀𝘁𝗿𝗮™️ 𝘁𝗲𝗮𝗺𝘀 𝗰𝗮𝗻 𝗰𝗿𝗲𝗮𝘁𝗲, 𝘁𝗲𝘀𝘁, 𝗮𝗻𝗱 𝗱𝗲𝗽𝗹𝗼𝘆 𝗮𝗴𝗲𝗻𝘁𝘀 𝘂𝘀𝗶𝗻𝗴 𝗮 𝗱𝗿𝗮𝗴-𝗮𝗻𝗱-𝗱𝗿𝗼𝗽 𝗰𝗮𝗻𝘃𝗮𝘀 - 𝗻𝗼 𝗰𝗼𝗱𝗶𝗻𝗴 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗱. Agents can connect to multiple internal systems and use various AI models to help with everyday Quality and Regulatory work, such as reading forms, creating summaries, Running risk assessments, classifying complaints, and automating critical workflows. Read the announcement and see what Orchestra can do for your team: einpresswire.com/article/888580… smarteeva.com/press-release-…

Daily medtech news with Smarteeva: 03 Feb ☑️ @korumedical receives FDA clearance for FreedomEDGE infusion system. Rystiggo is administered weekly, 3ml to 6ml over 15 to 30 minutes for six weeks. ☑️ @senseonics wins CE mark for Eversense 365 year-long CGM. It launched the year-long CGM implant with its global distribution partner, Ascensia Diabetes Care. ☑️ @GEHealthCare wins FDA, CE mark approval for Allia Moveo image-guided platform. It assists clinicians in a range of cardiovascular, non-vascular, interventional and surgical procedures. ☑️ @SiemensHealthineers wins FDA nod for PET/MR imaging scanner. The company says PET/MR can potentially reveal a tumor’s location and its metabolic activity and response to treatment. ☑️ @ImpCare_Stroke launches new Zoom 4S catheter. It built Zoom 4S for ease of use and to empower physicians with a device designed to navigate a range of patient anatomies. #InsightswithSmarteeva #Medtech #complaintmanagement #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

Daily medtech news with Smarteeva: 28 Jan ☑️ @OutsetMedical wins FDA nod for next-gen Tablo hemodialysis system. Outset said it architected the next-generation platform to offer enterprise-grade cybersecurity, reliability and usability. ☑️ @OathSurgical, @nvidia collaborate on AI-native surgical centers. The collaboration brings Nvidia’s advanced spatial AI infrastructure to Oath’s AI-native surgical centers. ☑️ @Robocath launches first-in-human study of next-gen robot for coronary artery disease. It develops robotic solutions that use bionic technology to optimise the safety of robotic-assisted coronary angioplasty. ☑️ @bostonscientific completes Nalu Medical acquisition. It agreed to provide an upfront cash payment of approximately $533 million for the remaining equity in the company. ☑️ @AbbottNews: Study shows neuromod systems greatly reduce pain-related healthcare visits. Abbott also received FDA approval for MRI compatibility in its chronic pain management portfolio. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

Daily medtech news with Smarteeva: 27 Jan ☑️ @penumbrainc launches next-gen Lightning Flash 3.0 thrombectomy system. It tailored this feature for large thrombus burdens and to reduce friction from aspirated thrombus. ☑️ @IntuitiveSurg wins FDA clearances for cardiac procedures on da Vinci 5. The da Vinci Xi surgical robotics system has already been used for minimally invasive cardiac procedures like mitral valve repair. ☑️ @HighLife received CE mark approval for its transcatheter mitral valve replacement (TMVR) system. ☑️ @Medtronic wins CE mark for Affera Sphere-360 PFA catheter, reports first U.S. IDE cases. It's a first-of-its-kind, all-in-one mapping and single-shot PFA catheter. ☑️ @SonoMotion achieves FDA clearance for kidney-stone-treating lithotripsy. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr

Daily medtech news with Smarteeva: 22 Jan ☑️ FDA clears @CepheidNews’s Xpert GI Panel for pathogen detection. A multiplex polymerase chain reaction (PCR) gastrointestinal (GI) pathogen testing solution. ☑️ @SonoMotion gains FDA clearance for Break Wave device to treat kidney stones. The platform will be showcased at booth 1508 during the 2026 American Urological Association meeting. ☑️ @momincubators wins FDA nod for first-of-its-kind portable incubator. Its novel design enables use anywhere, allowing mother and baby to stay together. ☑️ The FDA has flagged a @bostonscientific recall of its Axios stent and delivery system as potentially serious. The recall involves problems with stent deployment and expansion. ☑️ @BDandCo and @ypsomed develop a new version of Neopak XtraFlow syringe. The new 5.5ml BD Neopak XtraFlow Syringe uses BD’s advanced technologies, including thinner cannulas. #InsightswithSmarteeva #Medtech #complaintmanagement #Pharma #Smarteeva #biotech #medtechtrends #medtechindustry #medicaltechnology #technology #health #medicaldevicediagnostics #ai #mdr #recalls #complaints #mir #fda #cvr