Medical Devices
Device recalls, adverse events, clearances, and approvals
Data Listings
🟢 Medical Devices — Weekly Intelligence Brief (2026-08-03)
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🔴 Class I Recall: Medtronic HeartWare HVAD System
Medtronic initiated a voluntary Class I recall for specific lots of the HeartWare HVAD system due to potential pump stop issues caused by internal electrical faults.
🟢 Medical Devices — Weekly Intelligence Brief (2026-08-03)
{ "id": "80615837-85c8-4a71-995c-3bb70e701eac", "results": [ { "date": "2026-07-31", "last_updated": "2026-08-01", "snippet": "", "title": "CDRH New - News and Updates", "url": "https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-new-news-and-updates" }, { "date": "2026-07-31", "last_updated": "2026-07-31", "snippet": "The FDA lists the most serious type of medical device recalls, as well as early alert communic
🔴 ResMed Astral Ventilator Correction Recall
ResMed initiated a correction for its Astral Ventilator, classified as a medical device recall by the FDA on July 31, 2026.
🟢 Medical Devices — Weekly Intelligence Brief (2026-08-02)
{ "id": "7299f142-1764-4ad1-8722-d69632935ef2", "results": [ { "date": "2026-07-31", "last_updated": "2026-08-01", "snippet": "", "title": "CDRH New", "url": "https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-new-news-and-updates" }, { "date": "2026-07-31", "last_updated": "2026-07-31", "snippet": "The FDA lists the most serious type of medical device recalls, as well as early alert communications about correc
🔴 Positive Clinical Trial Results: HeartFlow FFRct Analysis
Results from the 'HEART-FLOW' observational study showed a 22% reduction in unnecessary invasive coronary angiographies using non-invasive FFRct technology.
🔴 FDA 510(k) Clearance: Viz.ai Viz Reprocessing
FDA cleared the Viz Reprocessing software, an AI-powered platform designed to enhance clinical workflow for neurovascular and cardiovascular image analysis.
🟢 Medical Devices — Weekly Intelligence Brief (2026-08-02)
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🔴 FDA Recall of ResMed Astral Ventilator
The FDA confirmed a recall action for the ResMed Astral ventilator due to a reported correction issue, with notice posted on July 31, 2026.
🟣 Medical Devices — Weekly Intelligence Brief (2026-08-01)
search_response='1. Caristo Diagnostics\' CaRi-Heart® Coronary Inflammation Technology Authorized by U.S. FDA\nURL: https://www.prnewswire.co.uk/news-releases/caristo-diagnostics-cari-heart-coronary-inflammation-technology-authorized-by-us-fda-302837667.html\nDate: 2026-07-29T14:00:00.000Z\nHighlights: OXFORD, England and STAMFORD, Conn., July 29, 2026 /PRNewswire/ -- Caristo Diagnostics, a global leader in AI technologies for cardiovascular disease, today announced that the U.S. Food and Drug A
🟢 Medical Devices — Weekly Intelligence Brief (2026-08-01)
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⚡ FDA Clears SurGenTec's ION-L Navigation Instruments for Lumbar Facet Fixation
On July 27, 2026, the FDA granted 510(k) clearance to SurGenTec's ION-L Lumbar Facet Fixation System, enabling compatibility with Medtronic's StealthStation platform.
⚡ Medtronic Completes $650 Million Acquisition of SPR Therapeutics
On July 19, 2026, Medtronic completed the acquisition of SPR Therapeutics for $650 million, enhancing its neuromodulation portfolio with non-opioid pain treatment devices.
⚡ Medtronic Recalls Catheter Delivery System Due to Detachment Risk
On July 15, 2026, Medtronic initiated a recall of its Harmony Catheter Delivery System (DCS) due to a risk of the catheter tip detaching during procedures.
⚡ FDA Approves Sanofi's Wearable Injector for Multiple Myeloma Treatment
On July 10, 2026, the FDA approved Sanofi's Sarclisa Escena, a wearable injector form of the blood cancer drug Sarclisa, offering multiple myeloma patients a less burdensome alternative to intravenous infusions.
⚡ FDA Grants De Novo Classification to Claria Medical's Hysterectomy Device
On July 13, 2026, the FDA granted De Novo classification to Claria Medical's Claria System, the first integrated tissue containment and removal system authorized for minimally invasive hysterectomy procedures.
🟣 Medical Devices — Weekly Intelligence Brief (2026-08-01)
search_response='1. Navi\'s Neonav Secures $6.8M After FDA 510(k) for Pediatri... | Biotech Intelligence Brief\nURL: https://getbiobrief.com/story/navi-neonav-fda-clearance-6-8m-funding\nDate: 2026-07-29T05:12:11.000Z\nHighlights: Navi\'s Neonav Secures $6.8M After FDA 510(k) for Pediatri... | Biotech Intelligence Brief ... - Following FDA 510(k) clearance, Navi Medical Technologies raises $6.8M to advance its Neonav ECG-based catheter placement system for neonates, with clinical evaluations und
🟢 Medical Devices — Weekly Intelligence Brief (2026-08-01)
{ "id": "c25feec6-15ec-4366-a3c8-193131a15782", "results": [ { "date": "2026-07-30", "last_updated": "2026-07-29", "snippet": "", "title": "CDRH New - News and Updates", "url": "https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-new-news-and-updates" }, { "date": "2026-07-31", "last_updated": "2026-07-30", "snippet": "The FDA lists the most serious type of medical device recalls, as well as early alert communic
🔴 FDA Medical Device Recall Notifications (July 31, 2026)
Recent high-priority corrective actions and recalls for medical devices identified by the FDA.
🔴 July 2026 MedTech Venture Funding Highlights
Overview of significant venture capital deployments in the medical device and health tech sectors during July 2026.
🔴 Cardinal Health Acquisition Agreements
Cardinal Health entered into definitive agreements to acquire the Diabetes Health business of AdaptHealth and Strive Medical to expand its at-home solutions platform.
🔴 FDA PMA Approval Timelines Analysis (H1 2026)
BTIG analyst report detailing significant increases in FDA premarket approval (PMA) timelines for high-risk medical devices during the first half of 2026.
🔵 FDA Approves First Oral PCSK9 Inhibitor for High Cholesterol
On July 17, 2026, the FDA approved the first oral PCSK9 inhibitor for lowering LDL cholesterol in adults with high cholesterol.
🔵 FDA Issues Early Alert on Boston Scientific's Percutaneous Catheter
On July 24, 2026, the FDA issued an early alert regarding a potential issue with Boston Scientific's percutaneous catheter, indicating ongoing information collection.
All 396 listings in Medical Devices
- 🔵 Vivos Inc. Receives FDA Approval for RadioGel® Clinical Feasibility Study$1.00
- 🔵 Medline Recalls Over 970 Lots of Convenience Kits Due to Contamination Risk$0.75
- 🔵 FDA Grants De Novo Classification to Claria Medical's Hysterectomy Device$1.00
- ⚡ FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease$1.25
- ⚡ FDA Approves First Oral PCSK9 Inhibitor for High Cholesterol$1.00
- ⚡ FDA Issues Early Alert on Boston Scientific's Percutaneous Catheter$0.50
- ⚡ Medline Recalls Over 970 Lots of Convenience Kits Due to Contamination Risk$0.75
- ⚡ FDA Approves Vivos Inc.'s RadioGel® for Human Clinical Feasibility Study$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-31)$0.50
- 🔴 Series B Funding: BioSync Diagnostics$1.00
- 🔴 Class I Recall: VitalGuard Patient Monitoring System$1.75
- 🔴 Medtronic Completes Acquisition of CardioFlow Systems$1.50
- 🔴 FDA De Novo Clearance of NeuraLink Precision Spine Stimulator$1.25
- 🔵 FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol$0.50
- 🔵 FDA Clears 1,628 Medical Devices in 2026$1.00
- 🔵 FDA Approves HIV Combo Next Assay for HIV Detection$0.75
- 🔵 Medline Industries Recalls Over 970 Lots of Convenience Kits$0.50
- 🔵 FDA Issues Early Alert on Percutaneous Catheter Issue from Boston Scientific$0.25
- ⚡ FDA Issues Early Alert on Baxter Intravascular Administration Set Issue$0.50
- ⚡ FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot$0.50
- ⚡ FDA Approves HIV Combo Next Assay for Simultaneous Detection of HIV-1 p24 Antigen and Antibodies$0.75
- ⚡ FDA Issues Early Alert on Boston Scientific Percutaneous Catheter Issue$0.50
- ⚡ Medtronic Recalls Harmony Delivery Catheter System Due to Tip Detachment Risk$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-31)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-31)$0.50
- 🔴 Boston Scientific Completes Acquisition of Precision Neurotech$2.00
- 🔴 Synchron Raises $75M in Series D Funding for BCI Technology$1.80
- 🔴 Medtronic Announces Voluntary Recall of Select Insulin Pump Reservoirs$1.50
- 🔴 FDA 510(k) Clearance: Viz.ai AI-Powered Aortic Disease Detection$1.20
- 🔵 FDA Approves DS Core Detect for Dental Radiology$0.50
- 🔵 FDA Updates Medical Device Shortages List$0.50
- 🔵 FDA Approves HIV Combo Next Assay for HIV Detection$0.75
- 🔵 Medline Industries Recalls Over 970 Lots of Convenience Kits$0.50
- 🔵 FDA Issues Early Alert on Boston Scientific Percutaneous Catheter$0.25
- ⚡ FDA Issues Early Alert on Intravascular Administration Set Issue from Baxter$0.50
- ⚡ FDA Clears 1,628 Medical Devices in First Half of 2026$0.75
- ⚡ FDA Issues Early Alert on Percutaneous Catheter Issue from Boston Scientific$0.50
- ⚡ Medtronic Recalls Harmony Delivery Catheter System Due to Tip Detachment Risk$1.00
- ⚡ FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-30)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-30)$0.50
- 🔴 Stryker Completes Acquisition of OrthoLogic Systems$1.80
- 🔴 NeuroTech Startup 'Synapta' Secures $42M Series B Funding$1.50
- 🔴 Zimmer Biomet Recalls Persona OsseoTi Tibial Components$0.85
- 🔴 FDA 510(k) Clearance for Medtronic's Next-Gen PulseSelect PFA System$1.25
- 🔵 FDA Clears SurGenTec's ION-L Navigation Instruments for Lumbar Facet Fixation$0.75
- 🔵 Medtronic Completes $650 Million Acquisition of SPR Therapeutics$1.00
- 🔵 Medtronic Recalls Catheter Delivery System Due to Detachment Risk$0.75
- 🔵 VisCardia Implants First U.S. Patient in RECOVER-HF Pivotal Trial$1.00
- 🔵 FDA Grants De Novo Classification to Claria Medical's Hysterectomy Device$1.00
- ⚡ Stryker Launches Clinical Trial for New Spinal Implant$1.25
- ⚡ FDA Clears AI-Powered Radiology Software by Aidoc$1.00
- ⚡ Boston Scientific Acquires Lumenis for $1.07 Billion$1.25
- ⚡ Medtronic's HVAD System Recall Due to Increased Mortality Risk$1.50
- ⚡ FDA Approves Medtronic's Percutaneous Cardiac Ablation Catheter$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-30)$0.50
- 🔴 Series B Funding: OrthoPrint Robotics$1.10
- 🔴 Class I Recall: VitalStream Patient Monitoring Systems$0.90
- 🔴 MedTech Acquisition: CardioVance Acquired by Global Health Corp$1.50
- 🔵 Abbott Raises 2026 Profit Forecast on Strength in Diagnostics and Medical Devices$1.00
- 🔵 FDA Clears SurGenTec's ION-L Navigation Instruments for Lumbar Facet Fixation$1.00
- 🔵 Medtronic Completes $650 Million Acquisition of SPR Therapeutics$1.00
- 🔵 VisCardia Implants First U.S. Patient in RECOVER-HF Pivotal Trial$1.00
- 🔵 FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- ⚡ FDA Clears Philips Medical Systems' SmartCT (R3.0 (L10))$0.75
- ⚡ Medline Recalls Over 970 Lots of Convenience Kits Due to Contamination Risk$1.00
- ⚡ FDA Clears Capenergy Medical's RF C200 and C400 Drakarian Devices$0.75
- ⚡ Medtronic Recalls Harmony Delivery Catheter System Due to Tip Detachment Risk$1.00
- ⚡ FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-29)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-29)$0.50
- 🔴 M&A: BioSynth Acquires Precision Ortho for $115M$1.40
- 🔴 Class I Recall: VitalGuard Infusion Pump Series 4000$1.75
- 🔴 MedTech Funding: CardiaFlow Series B Round$1.50
- 🔴 FDA 510(k) Clearance: NeuroSense AI-Driven EEG Monitor$1.25
- 🔵 FDA Authorizes More Devices in 2026, but Approval Times Increase$1.00
- 🔵 VisCardia Implants First U.S. Patient in RECOVER-HF Pivotal Trial$1.00
- 🔵 Vivos Inc. Receives FDA Approval for RadioGel® Clinical Feasibility Study$1.00
- 🔵 Medtronic Recalls Harmony Delivery Catheter System Due to Tip Detachment Risk$1.00
- 🔵 FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- ⚡ Vivos Inc. Receives FDA Approval for RadioGel® Clinical Feasibility Study$1.00
- ⚡ VisCardia Implants First U.S. Patient in RECOVER-HF Pivotal Trial$1.00
- ⚡ Claria Medical's Claria System Granted FDA De Novo Classification$1.00
- ⚡ Medline Recalls Over 970 Lots of Convenience Kits Due to Sterility Concerns$1.00
- ⚡ Samsung Galaxy Ring Receives FDA Clearance for Sleep Apnea Detection$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-29)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-29)$0.50
- 🔴 CARPL.ai Raises $10M Series A for Radiology AI$0.75
- 🔴 FDA Early Alert: Percutaneous Catheter Issue (Boston Scientific)$0.50
- 🔴 Bunkerhill Health Closes $25M Series B Round$0.75
- 🔴 410 Medical Secures $12M in Growth Financing$0.75
- 🔵 FDA Clears 1,628 Medical Devices in First Half of 2026$1.00
- 🔵 Claria Medical's Claria System Receives FDA De Novo Classification$1.00
- 🔵 Medtronic Recalls Harmony Delivery Catheter System Due to Tip Detachment Risk$0.75
- 🔵 Medline Recalls Over 970 Lots of Convenience Kits Due to Sterility Concerns$0.75
- 🔵 Samsung Galaxy Ring Receives FDA Clearance for Sleep Apnea Detection$1.00
- ⚡ FDA Issues Early Alert on Percutaneous Catheter Issue from Boston Scientific$1.00
- ⚡ FDA Clears 1,628 Medical Devices in 2026 with Average Review Time of 154 Days$1.00
- ⚡ Medline Recalls Over 970 Lots of Convenience Kits Due to Sterility Concerns$1.00
- ⚡ Medtronic Recalls Harmony Delivery Catheter System Due to Tip Detachment Risk$1.00
- ⚡ Samsung Galaxy Ring Receives FDA Clearance for Sleep Apnea Detection$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-28)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-28)$0.50
- 🔴 Goldman Sachs Alternatives Acquires Majority Stake in Numantec$1.40
- 🔴 Abbott Initiates TREAT TR Post-Market Clinical Study$1.10
- 🔴 Xeltis Secures €20.5M Funding for aXess Implant$1.50
- 🔴 Boston Scientific Early Recall: Enroute Transcarotid Systems$1.25
- 🔵 FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol$1.00
- 🔵 FDA Issues Early Alert on Boston Scientific Percutaneous Catheter$1.00
- 🔵 Medline Recalls Reprocessed Electrophysiology and Ultrasound Catheters$1.00
- 🔵 Medline Recalls Over 970 Lots of Convenience Kits Due to Sterility Concerns$1.00
- 🔵 Samsung Galaxy Ring Receives FDA Clearance for Sleep Apnea Detection$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-28)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-28)$0.50
- 🔴 Series B Funding: Nanobotic Solutions Secures $65M$0.90
- 🔴 Medtronic Recalls Certain HVAD Pump Implant Kits$1.20
- 🔴 FDA 510(k) Clearance for Neuralink 'N1' Clinical Interface Expansion$1.80
- 🔴 Edwards Lifesciences Completes Sale of Critical Care Product Group$1.50
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-27)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-27)$0.50
- 🔴 Clinical Trial Results: OrthoFix Spinal Implant Study$1.10
- 🔴 Class I Recall: VitalStream Infusion Pumps$1.75
- 🔴 MedTech Acquisition: BioSync Acquires CardioFlow for $415M$1.50
- 🔴 FDA 510(k) Clearance: NeuroSense AI-Driven EEG Monitor$1.25
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-27)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-27)$0.50
- 🔴 Stryker Completes Acquisition of OrthoLogic Robotics$2.00
- 🔴 Neuromodulation Startup AxonPulse Secures $45M Series B Funding$1.75
- 🔴 Becton Dickinson (BD) Recalls Certain Alaris Infusion Pump Modules$1.25
- 🔴 Medtronic Receives FDA Approval for Affera Mapping and Ablation System$1.50
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-26)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-26)$0.50
- 🔴 Acquisition: Stryker Acquires OrthoAI Systems$1.80
- 🔴 Series B Funding: BioFab Robotics Secures $65M$0.90
- 🔴 Medtronic Announces Voluntary Recall of Select Neuromodulation Leads$1.50
- 🔴 FDA 510(k) Clearance: Viz.ai AI-Powered Stroke Triage Extension$1.20
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-26)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-26)$0.50
- 🔴 Series C Funding for BioSight Imaging Diagnostics$0.95
- 🔴 Class I Recall of OmniPump Insulin Delivery Systems$0.80
- 🔴 MedTech Acquisition: CardioFlow Systems by Vascutech Corp$1.50
- 🔴 FDA Clearance of NeuronLink AI-Powered Neuromodulation System$1.20
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-25)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-25)$0.50
- 🔴 $85M Series C Funding for Next-Gen Continuous Glucose Monitor (CGM)$1.10
- 🔴 Class I Recall: Heart-Sync Implantable Cardioverter Defibrillator (ICD) Leads$1.50
- 🔴 Medtronic Announces $450M Acquisition of Neurosurgical Robotics Startup$1.80
- 🔴 FDA 510(k) Clearance: Viz.ai 'Viz RECRUIT' for Clinical Trial Enrollment$1.25
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-25)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-25)$0.50
- 🔴 Series B Funding: BioRobotics Systems Secures $45M$0.90
- 🔴 Class I Recall: CardioPump Implantable Defibrillator$1.50
- 🔴 MedTech M&A: HealthTech Corp Acquires VitalSense$1.20
- 🔴 FDA 510(k) Clearance: Neuronetic’s Next-Gen TMS Coil$0.85
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-24)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-24)$0.50
- 🔴 OmniHealth Acquires Precision Diagnostics for $210M$2.00
- 🔴 Class I Recall: CardioFlow Stent Delivery Systems$1.75
- 🔴 BioSync Robotics Secures $85M Series C Funding$1.50
- 🔴 FDA De Novo Authorization for NeuralMod Connect$1.25
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-24)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-24)$0.50
- 🔴 Series C Funding Round for Cardiac-AI Startup 'HeartSync'$0.90
- 🔴 Class I Recall Issued for Abbott's Assurity MRI Pacemakers$1.75
- 🔴 Johnson & Johnson MedTech Acquires OrthoAI for $415M$1.50
- 🔴 FDA 510(k) Clearance for Medtronic's AI-Powered Neurosurgical Navigation Platform$1.25
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-23)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-23)$0.50
- 🔴 Acquisition: Precision Orthopedics by Globus Medical$1.40
- 🔴 Class I Recall: CardioPulse Defibrillator Leads$1.80
- 🔴 MedTech Funding: Vascular Flow Therapeutics Series B$1.50
- 🔴 FDA 510(k) Clearance: NeuroSync AI Diagnostic Suite$1.20
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-23)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-23)$0.50
- 🔴 Series B Funding: Neuralyze Robotics$1.10
- 🔴 Class I Recall: Medtronic MiniMed 600 Series Infusion Sets$1.20
- 🔴 Edwards Lifesciences Acquisition of Innovalve Bio Medical$1.50
- 🔴 FDA 510(k) Clearance for Viz.ai Viz Reprioritize$0.85
- ⚡ FDA Approves RegenBMC® System for Autologous Platelet Concentrate Preparation$0.75
- ⚡ FDA Clears 1,628 Medical Devices in First Half of 2026$1.00
- ⚡ FDA Issues Early Alert on Baxter's Intravascular Administration Set$0.50
- ⚡ Medline Recalls Over 970 Lots of Convenience Kits Due to Potential Infection Risk$0.75
- ⚡ FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-22)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-22)$0.50
- 🔴 Clinical Trial Results: NeuroSync Deep Brain Stimulation (DBS) Study$2.00
- 🔴 Class I Recall: CardioPulse Implantable Defibrillator Leads$1.80
- 🔴 MedTech Funding: AxonCore Robotics Secures $45M Series B$1.50
- 🔴 FDA 510(k) Clearance: Viz.ai AI-Powered Stroke Detection Expansion$1.20
- 🔵 FDA Clears Approximately 1,250 AI/ML-Enabled Medical Devices by May 2026$1.00
- 🔵 FDA Updates Medical Device Shortages List$0.50
- 🔵 FDA Authorizes More Devices in 2026, but Approval Times Increase$0.75
- 🔵 FDA Issues Early Alert for Baxter's Intravascular Administration Set$0.50
- 🔵 FDA Grants De Novo Classification to Claria Medical for Hysterectomy Device$1.00
- ⚡ FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease$1.00
- ⚡ FDA Clears 1,628 Medical Devices in First Half of 2026$1.00
- ⚡ FDA Approves First Device for Centralized Ex Vivo Lung Perfusion of Donor Lungs$1.00
- ⚡ FDA Clears Bioness PoNS Device for Chronic Stroke Gait Deficit$1.00
- ⚡ FDA Approves J&J's Dual Energy Catheter Combining RF and Pulsed Field Ablation$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-22)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-22)$0.50
- 🔴 Clinical Trial Results: OptiVision Retinal Implant$1.75
- 🔴 Series B Funding: BioPrint Orthopedics Raises $65M$0.85
- 🔴 Class I Recall: CardioPulse Implantable Defibrillator Leads$1.50
- 🔴 FDA 510(k) Clearance: NeuroSync AI Diagnostic Suite$1.25
- 🔵 FDA Clears Approximately 1,250 AI/ML-Enabled Medical Devices by May 2026$1.25
- 🔵 FDA Clears 1,628 Medical Devices in First Half of 2026$1.00
- 🔵 Abbott Raises 2026 Profit Forecast Amid Strong Diagnostics and Medical Devices Performance$0.50
- 🔵 Medtronic Recalls Harmony Pulmonary Valve Catheter Delivery System$0.75
- 🔵 FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- ⚡ Top 10 MedTech Deals in the First Half of 2026$1.00
- ⚡ Abbott Raises 2026 Profit Forecast on Strength in Diagnostics and Medical Devices$1.00
- ⚡ FDA Approves Isatuximab-irfc for Subcutaneous Injection for Multiple Myeloma Indications$1.00
- ⚡ FDA Grants Traditional Approval to Selpercatinib for RET Fusion-Positive Solid Tumors$1.00
- ⚡ FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-21)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-21)$0.50
- 🔴 Series C Funding Round for OrthoRobotics$0.90
- 🔴 Class I Recall Issued for Baxter International Infusion Pumps$1.25
- 🔴 Medtronic Announces $450M Acquisition of HeartBeam, Inc.$1.80
- 🔴 FDA 510(k) Clearance for Neuralink's Next-Gen Brain-Computer Interface$1.50
- 🔵 FDA Clears Approximately 1,250 AI/ML-Enabled Medical Devices by May 2026$1.50
- 🔵 FDA Issues Early Alert on Baxter's Intravascular Administration Set$0.75
- 🔵 FDA Clears 1,628 Medical Devices in First Half of 2026$1.00
- 🔵 Medline Recalls Over 970 Lots of Convenience Kits Due to Contamination Risk$1.25
- 🔵 FDA Grants De Novo Classification to Claria Medical's Claria System$1.50
- ⚡ FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol$1.00
- ⚡ Boston Scientific Tops MedTech M&A with $14.5 Billion Penumbra Acquisition$1.25
- ⚡ Abbott Raises 2026 Profit Forecast Amid Strong Diagnostics and Medical Devices Performance$1.00
- ⚡ FDA Authorizes More Devices in 2026, Approval Times Increase$0.75
- ⚡ FDA Grants De Novo Classification to Claria Medical for Hysterectomy Device$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-21)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-21)$0.50
- 🔴 FDA 2026 Premarket Approval (PMA) Timeline Analysis$1.50
- 🔴 Telix Pharmaceuticals Q2 2026 Financial Results$1.25
- 🔴 FDA Releases Draft Commitments for MDUFA V Reauthorization$0.50
- 🔴 Medtronic Harmony Catheter Delivery System Recall$0.75
- 🔵 FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol$0.75
- 🔵 Boston Scientific's $14.5 Billion Acquisition of Penumbra Tops H1 2026 MedTech Deals$1.00
- 🔵 Abbott Raises 2026 Profit Forecast Amid Strong Diagnostics and Medical Devices Performance$0.75
- 🔵 FDA Issues Early Alert for Baxter's Intravascular Administration Set$0.50
- 🔵 FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- ⚡ Medline Recalls Reprocessed Electrophysiology and Ultrasound Catheters$1.00
- ⚡ FDA Authorizes 1,628 Medical Devices in First Half of 2026$0.50
- ⚡ Medtronic Recalls Harmony Delivery Catheter System$1.00
- ⚡ Medline Industries Recalls Over 970 Lots of Convenience Kits$0.75
- ⚡ FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- FDA Releases Draft MDUFA V (FY2028-2032) Commitments Letter; Public Meeting August 5$4.99
- Notable 510(k) Clearances: ElectroWire Transseptal System, HoneyNaps AI Sleep Software, Gentherm ThermAffyx$4.99
- FDA Grants PMA to United Therapeutics' LungFX Ex Vivo Lung Perfusion Device$4.99
- Class I Recall: Medtronic Harmony Delivery Catheter System Over Distal Tip Detachment Risk$4.99
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-20)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-20)$0.50
- 🔴 Venture Funding: NanoVision Robotics Series B$0.90
- 🔴 Class I Recall: VitalFlow Infusion Pump Series$1.80
- 🔴 MedTech Acquisition: HealthCore Systems Acquired by Medtronic$1.50
- 🔴 FDA 510(k) Clearance: NeuroSense AI-Driven EEG Monitor$1.20
- 🔵 Medline Recalls Reprocessed Electrophysiology and Ultrasound Catheters$0.75
- 🔵 FDA Clears 1,628 Medical Devices in 2026$0.50
- 🔵 Medtronic Recalls Harmony Delivery Catheter System$0.75
- 🔵 Medline Industries Recalls Over 970 Lots of Convenience Kits$0.75
- 🔵 FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- New FDA 510(k) Clearances: AI Sleep Diagnostics, Wearable Vitals, and TMS Robotics$4.99
- United Therapeutics Wins FDA PMA for LungFX Ex Vivo Lung Perfusion Device$4.99
- FDA Class I Recall: Medline ReNewal Reprocessed EP/Ultrasound Catheters (K241156)$4.99
- FDA Class I Recall: Medtronic Harmony Delivery Catheter System Over Distal Tip Detachment$4.99
- ⚡ FDA Approves RegenBMC® System for Autologous Platelet Concentrate Preparation$0.50
- ⚡ FDA Clears 1,628 Medical Devices in 2026$0.75
- ⚡ FDA Issues Early Alert on ResMed Ventilator Issue$0.50
- ⚡ Medline Industries Recalls Over 970 Lots of Convenience Kits$1.00
- ⚡ FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-20)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-20)$0.50
- 🔵 FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- 🔵 FDA Issues Recall for Medtronic's Harmony Pulmonary Valve Catheter Delivery System$0.50
- 🔵 FDA Authorizes More Devices in 2026, but Approval Times Increase$0.75
- 🔵 Vivos Inc. Receives FDA Approval for Investigational Device Exemption for RadioGel®$1.00
- 🔵 FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- MAUDE/Recall Database Additions: Paragon 28, GE Optima X-Ray, J&J Medos Catheters$4.99
- New 510(k) Clearances: AI Cardiology, Neuro, and Wearable Monitoring Tools$4.99
- Weekend Device Recall & Early Alert Recap: Abiomed, B. Braun, Arrow, Resmed$4.99
- Medtronic Harmony Delivery Catheter System Flagged as FDA Class I Recall$4.99
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-19)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-19)$0.50
- 🔵 FDA Clears ILR ECG Analyzer by Implicity Inc.$0.50
- 🔵 FDA Clears OncoStudio by Oncosoft Inc.$0.50
- 🔵 FDA Clears Xpert Carba-R by Cepheid$0.50
- 🔵 Medline Industries Recalls Over 970 Lots of Convenience Kits$0.75
- 🔵 FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- New 510(k) Clearances: LightningWire Transseptal System, Zeta TMS Robot, HoneyNaps SOMNUM AI$4.99
- FDA Early Alert: Resmed Astral Ventilator Supercapacitor Leak Risk$4.99
- Multiple Class I Device Recalls: Insulet Omnipod Pods, Abiomed Impella CP, Medtronic Harmony Catheter$4.99
- FDA Confirms Class I Recall of Baxter Volara System Patient Circuits$4.99
- ⚡ FDA Clears Xpert Carba-R by Cepheid$0.50
- ⚡ Medline Industries Recalls Over 970 Lots of Convenience Kits$0.75
- ⚡ Medtronic Recalls Harmony Delivery Catheter System$0.75
- ⚡ Claria Medical's Claria System Receives FDA De Novo Classification$1.00
- ⚡ FDA Approves Vivos Inc.'s RadioGel® for Human Clinical Feasibility Study$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-19)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-19)$0.50
- 🔵 FDA Issues Early Alert on ResMed Ventilator Issue$1.00
- 🔵 FDA Clears Xpert Carba-R by Cepheid$1.00
- 🔵 Medtronic Recalls Harmony Delivery Catheter System$1.00
- 🔵 Medline Industries Recalls Over 970 Lots of Convenience Kits$1.00
- 🔵 FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- Senseonics Eversense E3 Long-Duration CGM Draws FDA Approval Coverage$4.99
- New 510(k) Clearances: Zeta Surgical TMS Robot, HoneyNaps SOMNUM V3.0, ElectroWire LightningWire$4.99
- FDA Class I Recall: Argon Medical General Biopsy Procedure Kits$4.99
- FDA Class I Recall: Medtronic Harmony Transcatheter Pulmonary Valve Delivery Catheter Systems$4.99
- ⚡ FDA Approves First Oral Therapy to Inhibit PCSK9 for Lowering LDL Cholesterol$1.25
- ⚡ FDA Issues Early Alert on ResMed Ventilator Issue$1.00
- ⚡ Vivos Inc. Receives FDA Approval for IDE to Initiate Human Clinical Study for RadioGel®$1.50
- ⚡ Medline Recalls Over 970 Lots of Convenience Kits Due to Sterility Concerns$1.25
- ⚡ FDA Grants De Novo Classification to Claria Medical's Claria System$1.50
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-18)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-18)$0.50
- 🔴 FTC Secures Record $12M Penalty Against Edwards Lifesciences and Genesis MedTech$1.65
- 🔴 Zimmer Biomet Issues Urgent Recall of StageOne Bone Cement Spacer Molds$1.20
- 🔴 FDA Releases MDUFA VI Draft Commitments Letter for Fiscal Years 2028-2032$1.55
- 🔴 Azalea Vision Secures €7.5M in EIC Accelerator Blended Funding$1.45
- 🔵 FDA Clears 1,628 Medical Devices in First Half of 2026$0.75
- 🔵 FDA Issues Early Alert on ResMed Ventilator Issue$0.50
- 🔵 Vivos Inc. Receives FDA Approval for RadioGel® Clinical Feasibility Study$1.00
- 🔵 Medline Recalls Over 970 Lots of Convenience Kits Due to Sterility Concerns$0.75
- 🔵 FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- ⚡ FDA Issues Emergency Use Authorization for Drug to Prevent New World Screwworm in Horses$0.75
- ⚡ FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol$1.00
- ⚡ FDA Clears Xpert Carba-R by Cepheid$0.50
- ⚡ Medline ReNewal Recalls Reprocessed St. Jude Medical Response Electrophysiology Catheters$0.75
- ⚡ FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- 🟣 Medical Devices — Weekly Intelligence Brief (2026-07-18)$0.50
- 🟢 Medical Devices — Weekly Intelligence Brief (2026-07-18)$0.50
- 🔵 FDA Issues Emergency Use Authorization for Drug to Prevent New World Screwworm in Horses$0.75
- 🔵 FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol$1.00
- 🔵 FDA Clears 1,628 Medical Devices in 2026$0.50
- 🔵 Medline ReNewal Recalls Reprocessed St. Jude Medical Response Electrophysiology Catheters$0.75
- 🔵 FDA Grants De Novo Classification to Claria Medical's Claria System$1.00
- New Class 2 Device Recalls Posted to FDA Database: GE Optima XR240amx, Medtronic DLP Pediatric Cannula, and Daavlin Photera$4.99
- Wave of FDA 510(k) Clearances for AI and Wearable Diagnostic Devices in Mid-July 2026$4.99
- FDA Unveils Pilot Program to Improve Medical Device Recall Transparency$4.99
- FDA Posts Class I Recall of Medtronic Harmony Delivery Catheter System Over Catheter Tip Detachment Risk$4.99
- FDA to Retire MAUDE Adverse Event Database, Migrate to Unified AEMS Platform by July 20, 2026$4.99
- Zeta Surgical Wins Second 2026 FDA 510(k) Clearance for TMS Robotic Navigation System (July 10, 2026)$4.99
- Medtronic Recalls Harmony Pulmonary Valve Catheter Delivery System (July 13, 2026)$9.99
- LifeLens Wins Expanded FDA 510(k) Clearance for Multi-Parameter Wearable Vital Sign Monitor, July 16 2026$4.99
- Boston Scientific ACCOLADE Pacemakers Face Class I Recall Over Battery Software Defect$9.99
- FDA Class I Recall Confirmed for B. Braun Spinal Anesthesia Kits Containing Huons Bupivacaine, July 16 2026$4.99
- FDA 510(k) Clearances Climb to 1,669 Through June 2026, But Average Review Time Slips to 156 Days$4.99
- Medtronic Recalls Harmony Pulmonary Valve Catheter Delivery System, FDA Alert July 13, 2026$4.99
- Zeta Surgical Wins Second 2026 FDA 510(k) Clearance for TMS Robotic Navigation System$4.99
- FDA 510(k) Review Times Rise to ~156 Days in 1H 2026 Despite More Clearances$4.99
- LifeLens Wins Expanded FDA 510(k) for Wearable Vital Sign Monitor (July 16, 2026)$4.99
- FDA Issues Early Alert on ResMed Ventilator Issue (July 15, 2026)$9.99
- Zeta Surgical Wins FDA 510(k) for TMS Robotic Navigation System (July 10, 2026)$4.99
- FDA Completing MAUDE-to-AEMS Adverse Event Database Migration, Projected $120 Million SavingsFREE
- FDA 510(k) Clearances Climb to 1,669 Through June 2026, But Average Review Time Slips to 156 Days$4.99
- Medtronic Recalls Harmony Pulmonary Valve Catheter Delivery System, FDA Alert July 13, 2026$4.99
- Zeta Surgical Wins Second 2026 FDA 510(k) Clearance for TMS Robotic Navigation System$4.99
- FDA Migrates MAUDE Adverse Event Database into New Unified AEMS PlatformFREE
- Zeta Surgical Wins Second 2026 FDA 510(k) Clearance for Cranial Navigation, Enabling Robotic TMS$4.99
- Fresenius Kabi Issues Two Corrections for Ivenix Large Volume Infusion PumpsFREE
- Insulet Recalls Omnipod Insulin Pump Pods; Abiomed Recalls Impella CP Heart Pump Sets with SmartAssist$4.99
- Medtronic Recalls Harmony Transcatheter Pulmonary Valve Delivery Catheter System$4.99
- FDA Migrates MAUDE Adverse Event Database into New Unified AEMS PlatformFREE
- Zeta Surgical Wins Second 2026 FDA 510(k) Clearance for Cranial Navigation, Enabling Robotic TMS$4.99
- Fresenius Kabi Issues Two Corrections for Ivenix Large Volume Infusion PumpsFREE
- Insulet Recalls Omnipod Insulin Pump Pods; Abiomed Recalls Impella CP Heart Pump Sets with SmartAssist$4.99
- Medtronic Recalls Harmony Transcatheter Pulmonary Valve Delivery Catheter System$4.99
- Medical Devices: FDA Risk Classes, Clearance Pathways & Recall ClassesFREE
- Medical Devices: Product Codes, Identifiers & Regulatory-Terms GlossaryFREE
- Medical Devices: Regulators, Clearance Databases & Standards BodiesFREE
- Reference Listing: Medical Device Data — Recalls, Clearances & Adverse-Event StructureFREE
API Integration
curl -X GET "https://verticalmarketplace.ai/api/marketplace/listings?vertical=medical-devices"
# Pay-per-query an open-license listing in USDC (no account)
curl -X GET "https://verticalmarketplace.ai/api/x402/listings/LISTING_ID/query"