Regulation — older stories
135 stories beyond the latest 40.
- 081RegulationSource · Medical Device Network
Novocure receives CE mark for Optune Pax device
Novocure received CE Mark approval for Optune Pax, a portable device designed to treat adults with locally advanced exocrine pancreatic cancer. The clearance enables the company to market the device in the European Union and other regions that recognize CE certification.
- 082RegulationSource · Medical Device Network
FDA clears Bioness Medical’s neuromodulation system for stroke rehabilitation
The FDA has cleared Bioness Medical's PoNS (Portable Neuromodulation Stimulator) system for stroke rehabilitation. The device uses neuromodulation to stimulate the trigeminal and facial cranial nerves, targeting improvement of gait impairment in stroke patients. The clearance expands the therapeutic applications available to rehabilitation providers and hospitals treating post-stroke motor dysfunction.
- 083RegulationSource · Medical Device Network
FDA approves Artivion’s AMDS device PMA
Artivion received FDA PMA clearance for its AMDS Hybrid Prosthesis device, indicated for treatment of acute DeBakey Type I aortic dissections with clinical or radiographic malperfusion. The approval permits commercial distribution in the US market.
- 084RegulationSource · Medical Design & Outsourcing
What’s UpDoc? The SaMD developer says it’s the first FDA-cleared clinical AI platform
UpDoc obtained FDA 510(k) clearance for a software-as-a-medical-device platform that integrates patient-facing large language models for clinical use, marking what the company claims is the first such FDA-cleared SaMD of its kind. The clearance signals regulatory acceptance of LLM-based clinical AI tools and may establish a pathway for similar developers.
- 085RegulationSource · Medical Device Network
FDA grants breakthrough status to Aidoc’s AI radiology report system
The FDA has granted breakthrough device designation to Aidoc's First Read, an AI system that generates preliminary radiology report text from chest radiograph analysis. Breakthrough status expedites the FDA review pathway for devices addressing unmet clinical needs or offering significant advantages over existing alternatives.
- 086RegulationSource · Medical Design & Outsourcing
FDA warns it will reject test results from three third-party labs due to ‘unreliable’ data
The FDA announced it will reject all data from studies conducted at three Chinese third-party testing facilities due to unreliable or falsified data. The enforcement actions, part of an ongoing crackdown, affect labs that have submitted invalid or compromised test results since 2024. The rejections will impact device manufacturers relying on these facilities for safety and performance validation needed for FDA submissions.
- 087RegulationSource · Medical Device Network
BrightHeart secures CE mark for AI-powered prenatal ultrasound platform
BrightHeart obtained CE mark approval for its B-Right AI platform, an artificial intelligence system designed for prenatal ultrasound analysis. The certification enables the company to expand the technology into European markets while continuing its US rollout.
- 088RegulationSource · Medical Device Network
Quest Diagnostics’ Haystack MRD test secures NYSDOH approval
Quest Diagnostics received approval from the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) for its Haystack minimal residual disease (MRD) test, enabling broader clinical use across the United States. The test detects residual cancer cells in patient samples post-treatment.
- 089RegulationSource · Medical Device Network
PorTal Access secures FDA clearance for vascular access ports
PorTal Access received FDA clearance for its FLEXI-PORT family of vascular access devices, designed to offer flexibility and versatility in vascular access applications. The clearance expands the company's portfolio of vascular access solutions for clinical use.
- 090RegulationSource · Medical Device Network
Masimo secures FDA approval for OIRD detection on wearable patient monitor
Masimo received FDA 510(k) clearance for an opioid-induced respiratory depression (OIRD) detection feature on its Radius VSM wearable patient monitor. The clearance enables the device to detect and alert clinicians to respiratory depression associated with opioid use in monitored patients.
- 091RegulationSource · Medical Device Network
Abiomed’s Impella heart pump introducer kits linked to leakage issue in FDA alert
Abiomed reported eight cases of major bleeding associated with leakage in Impella heart pump introducer kits, including three deaths, triggering an FDA safety alert. The company disclosed the issue through regulatory channels as part of ongoing device surveillance.
- 092RegulationSource · Medical Device Network
Novocure’s Optune Gio fails to show benefit at earlier stage
Novocure announced that its Phase III TRIDENT study failed to demonstrate statistical significance in overall survival when Optune Gio was used at an earlier disease stage. The result suggests the device does not provide benefit in this earlier-stage indication, likely impacting the company's development strategy and regulatory pathway for expanded labeling.
- 093RegulationSource · Medical Device Network
FiberSense plans CGM’s commercial readiness following CE mark
FiberSense has obtained CE mark approval for its continuous glucose monitoring (CGM) device, which uses optical sensor technology to measure glucose in subcutaneous tissue fluid. The company plans next steps toward commercial readiness following the regulatory clearance.
- 094RegulationSource · Medical Device Network
AngioDynamics secures FDA approval for RELIEF study of NanoKnife
AngioDynamics received FDA approval for an Investigational Device Exemption (IDE) to initiate the RELIEF clinical trial of its NanoKnife system. NanoKnife is an irreversible electroporation (IRE) platform used in surgical ablation procedures. The IDE clearance permits the company to begin enrolling patients in the controlled trial, a key milestone in the development pathway for the device.
- 095RegulationSource · Medical Device Network
Distalmotion secures second FDA gynaecology clearance for DEXTER system
Distalmotion, a Swiss medical device manufacturer, obtained FDA 510(k) clearance for its DEXTER Robotic Surgery System for gynecological procedures including sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection. This marks the company's second FDA clearance for gynecological applications of the robotic platform.
- 096RegulationSource · Medical Design & Outsourcing
FDA device shortage update includes bloodlines, biopsy needles and more
The FDA updated its device shortage and discontinuance lists, resolving a shortage of dialysis bloodlines while extending expected shortage durations for stereotactic breast biopsy needles, endoscopic vessel harvesting systems, and oxygenator devices for extracorporeal circulation. The extended shortages affect suppliers and hospitals dependent on these critical equipment categories.
- 097RegulationSource · Medical Device Network
Penumbra’s Thunderbolt approval poised to accelerate neuro thrombectomy innovation
Penumbra received FDA approval for its Thunderbolt system, the first device to offer CAVT (catheter-assisted vacuum thrombectomy) for stroke intervention. The clearance enables the company to commercialize the neuro thrombectomy device and positions it as the initial market entrant for this intervention modality.
- 098RegulationSource · Medical Device Network
FDA clears SurGenTec’s facet fixation system for degenerative disc disease treatment
The FDA cleared SurGenTec's ION-L facet fixation system for treating degenerative disc disease. The clearance was based on data from an IRB-approved study and positions the device as a less invasive alternative for spinal fixation procedures.
- 099RegulationSource · Medical Device Network
FDA approves Bayer’s Ambelvist contrast agent
The FDA has approved Bayer's Ambelvist, a macrocyclic gadolinium-based contrast agent (mGBCA), for MRI imaging in adults and children, including term neonates. The approval expands the available contrast options for magnetic resonance imaging across pediatric and adult populations.
- 100RegulationSource · Medical Device Network
FDA clears Dexcom’s Stelo as first OTC glucose monitor for children
The FDA cleared Dexcom's Stelo continuous glucose monitor (CGM) for over-the-counter use in pediatric patients, making it the first OTC CGM approved for children. The clearance expands the product's indication from adults to include pediatric users with diabetes, enabling direct consumer access without prescription.
- 101RegulationSource · Medical Device Network
FDA oncology roundup: drugs, imaging agents and diagnostics gain approval
The FDA has granted clearances to multiple oncology products including drugs, imaging agents, and diagnostics. The approvals span therapeutics and companion diagnostics, affecting suppliers across imaging, laboratory diagnostics, and related oncology device categories.
- 102RegulationSource · Medical Device Network
FDA clears Penumbra’s Thunderbolt thrombectomy platform for stroke
The FDA has cleared Penumbra's Thunderbolt thrombectomy platform, a computer-assisted vacuum aspiration system designed for clot removal during acute ischemic stroke treatment. The clearance enables commercial distribution of the device for this indication.
- 103RegulationSource · Medical Device Network
Wave Neuroscience wins FDA clearance for precision PTSD therapy
Wave Neuroscience received FDA clearance for its MeRT platform, which uses transcranial magnetic stimulation (TMS) tailored to individual patient brain data for PTSD treatment. The system records patient-specific neural activity to customize stimulation parameters, enabling personalized therapy delivery.
- 104RegulationSource · Medical Design & Outsourcing
A boy’s death is a tragic example of foreseeable risk in device design
A medical device recall involving a hospital bed has resulted in a child fatality, highlighting design flaws that were foreseeable during development. The incident underscores the importance of hazard analysis and risk mitigation in device design for medtech engineers and manufacturers to prevent similar failures in equipment safety and compliance.
- 105RegulationSource · Medical Device Network
Subtle Medical lands FDA clearance for AI CT imaging software
Subtle Medical received FDA clearance for SubtleHD(CT), an AI software tool designed to enhance CT image quality. The clearance expands the company's portfolio of AI imaging products, which already includes SubtlePET for PET imaging and SubtleHD(MR) for MR imaging enhancement.
- 106RegulationSource · Medical Device Network
FDA clears KARL STORZ’s RUBINA Lens for use in open surgery
KARL STORZ received FDA clearance for its RUBINA Lens exoscope for use in open surgical procedures. The exoscope is a visualization tool that provides magnified, high-definition imaging during open surgery, enabling surgeons to view the operative field with enhanced detail and precision.
- 107RegulationSource · Medical Device Network
Sibel Health’s ANNE One platform secures EU MDR CE mark
Sibel Health has obtained CE mark certification under the EU Medical Device Regulation for its ANNE One system, which has been classified as a Class IIb medical device. The certification enables the platform to be marketed across the EU.
- 108RegulationSource · Medical Device Network
FDA grants IDE to SpinaFX for study of Triojection
SpinaFX Medical received FDA investigational device exemption (IDE) approval to conduct clinical studies of its Triojection therapy, a spinal intervention device. The IDE clearance permits human investigation of the device as part of the regulatory pathway toward potential market authorization.
- 109RegulationSource · Medical Device Network
Gore secures CE Mark for venous stent to treat inferior vena cava
Gore obtained CE Mark approval for its Gore Viabahn Fortegra venous stent under the EU Medical Device Regulation. The stent is indicated for symptomatic inferior vena cava and iliofemoral venous outflow obstruction, clearing the device for European market distribution.
- 110RegulationSource · Medical Device Network
FDA clears Xenix Medical’s Lux fusion system
The FDA has cleared Xenix Medical's Lux fusion system, a spinal fusion surgical device designed to improve procedural success rates and offer greater flexibility after implant placement.
- 111RegulationSource · Medical Device Network
Medtronic secures CE mark for Stealth AXiS system for ENT surgery
Medtronic obtained CE mark approval for its Stealth AXiS surgical system for ENT procedures, enabling market entry across Europe. The system supports image-guided surgery in otolaryngology applications.
- 112RegulationSource · Medical Device Network
FDA issues early alert for GE HealthCare’s infant resuscitation systems
The FDA issued an early alert regarding GE HealthCare's infant resuscitation systems, citing a potential issue with certain blenders that mix air and oxygen to deliver controlled oxygen concentration. The alert affects devices used in neonatal and pediatric critical care settings.
- 113RegulationSource · Medical Device Network
Tandem secures CE mark for AID systems in T2D and T1D with pregnancy
Tandem Diabetes Care obtained CE mark approval for expanded indications of its automated insulin delivery systems, now cleared for use in type 2 diabetes and type 1 diabetes patients who are pregnant. The expanded authorization widens the addressable patient population in European markets for Tandem's AID platform.
- 114RegulationSource · Medical Device Network
Zepto Life Technology’s mould infection panel obtains FDA breakthrough designation
Zepto Life Technology's FungiFlex mould panel has received FDA Breakthrough Device designation. The panel identifies 14 clinically important mould species using cell-free fungal DNA detection in plasma, enabling faster diagnosis of invasive fungal infections in immunocompromised patients.
- 115RegulationSource · Medical Device Network
FDA approves GE HealthCare’s MIM Contour ProtégéAI+ 2.0 software
GE HealthCare received FDA 510(k) clearance for MIM Contour ProtégéAI+ 2.0, an AI-powered software tool. The clearance expands GE's portfolio of computational aids for medical imaging and oncology planning workflows, enabling vendors and providers to adopt the updated solution for clinical use.
- 116RegulationSource · Medical Device Network
Medtronic seeks FDA clearance for Hugo RAS system
Medtronic has filed with the FDA seeking to expand clearance for its Hugo RAS robotic-assisted surgery system to general and gynaecologic surgery indications. The company submitted multiple regulatory filings to broaden the platform's approved use cases beyond its current scope.
- 117RegulationSource · Medical Design & Outsourcing
FDA rules, regulations and resources for artificial intelligence in medical devices
The FDA has issued guidance on how artificial intelligence and machine learning in medical devices will be regulated. Manufacturers incorporating AI/ML into products must determine regulatory classification and whether the software itself requires separate oversight. The guidance clarifies FDA authority over both device hardware and software components.
- 118RegulationSource · Medical Device Network
Philips secures FDA clearance for Elevate Plus AI ultrasound upgrade
Philips received FDA 510(k) clearance for Elevate Plus, a software upgrade that adds imaging and AI capabilities to its EPIQ Elite and Affiniti ultrasound systems. The clearance enables the company to deploy enhanced diagnostic features across its installed base of ultrasound platforms.
- 119RegulationSource · Medical Design & Outsourcing
FDA picks Nephrodite’s implantable dialysis system for TAP pilot
Nephrodite's Holly implantable continuous dialysis system has been selected for the FDA's Total Product Life Cycle Advisory Program (TAP) pilot. The device previously received FDA Breakthrough Device Designation. The TAP program is designed to expedite patient access to innovative medical devices through enhanced regulatory guidance and support.
- 120RegulationSource · Medical Device Network
Podcast: Assessing the EMA’s new innovative medical device pathway pilot
The European Medicines Agency has launched a pilot programme offering expert support to manufacturers developing breakthrough medical devices through a new innovative device pathway. The initiative is designed to streamline regulatory review and guidance for qualifying emerging technologies, potentially accelerating time to market for novel solutions.