Regulation — older stories
188 stories beyond the latest 40.
- 121RegulationSource · Medical Device Network
Johnson & Johnson’s DE STSF platform secures FDA approval
Johnson & Johnson received FDA approval for its Dual Energy Thermocool Smarttouch SF Platform (DE STSF), a radiofrequency ablation system. The platform is designed for cardiac arrhythmia treatment and incorporates dual-energy technology with the company's Smarttouch contact-force sensing capability.
- 122RegulationSource · Medical Design & Outsourcing
FDA releases draft MDUFA VI agreement outlining proposed legislation and program changes
The FDA released a draft Medical Device User Fee Amendments (MDUFA) VI commitment letter outlining proposed changes to its device review program. The draft includes a faster pre-submission track, earlier communication for de novo applicants, and a new international harmonization pilot program. MDUFA VI represents the agency's reauthorization agreement with the medtech industry.
- 123RegulationSource · Medical Device Network
First patient enrolled in AtaCor’s ALARION-EV trial of EV-ICD system
AtaCor Medical has enrolled the first patient in its ALARION-EV pivotal trial, evaluating an investigational extravascular implantable cardioverter-defibrillator (EV-ICD) system. The trial represents a key regulatory milestone toward potential FDA clearance for the device, which aims to offer an alternative to traditional transvenous ICD implantation.
- 124RegulationSource · Medical Device Network
Beckman Coulter’s Alzheimer’s blood test obtains CE mark
Beckman Coulter received CE mark approval for a blood-based assay measuring phosphorylated tau (pTau217) levels in patients with cognitive decline. The test enables earlier detection and monitoring of Alzheimer's disease through a minimally invasive diagnostic approach.
- 125RegulationSource · Medical Device Network
NICE greenlights first non-invasive endometriosis diagnostic tools
The UK's National Institute for Health and Care Excellence (NICE) has approved two non-invasive endometriosis diagnostic tools—EndoSure and Ziwig Endotest—for use in NHS clinical practice as complementary diagnostics alongside standard evaluation. The clearance marks the first regulatory endorsement of non-invasive diagnostics for endometriosis in the UK market.
- 126RegulationSource · Medical Device Network
FDA clears Visby Medical’s at-home Covid-19 and Influenza PCR test
Visby Medical received FDA clearance for an at-home PCR test that detects both COVID-19 and influenza, delivering results within 30 minutes. The multiplex assay enables patients to self-test and differentiate between the two respiratory viruses without laboratory infrastructure.
- 127RegulationSource · Medical Device Network
Median Technologies receives CE marking for eyonis LCS
Median Technologies received CE marking for eyonis LCS, an AI-based software-as-a-medical-device platform, under the European Medical Device Regulation. The clearance enables commercial distribution of the software in EU markets.
- 128RegulationSource · MedCity News
This Ear-Based Device Could Save Patients from Brain Bleed Complications
Aurenar's V-Link, a non-invasive ear-based nerve stimulation device designed to prevent complications from brain hemorrhage, received FDA breakthrough device designation following early-stage trials that demonstrated greater than 40% reduction in cerebral vasospasm. The designation accelerates the device's regulatory pathway toward clearance.
- 129RegulationSource · Medical Device Network
MHRA investigation leads to convictions in counterfeit baby feeding devices case
The UK Medicines and Healthcare products Regulatory Agency (MHRA) investigation resulted in convictions against Medicina for supplying counterfeit baby feeding devices with false CE markings to NHS Trusts and other UK healthcare providers. The case highlights enforcement action against non-compliant medical device vendors in the infant nutrition supply chain.
- 130RegulationSource · MedCity News
FDA Clears First Neurostimulation Device for PTSD
Neurovalens received FDA clearance for Modius Spero, the first neurostimulation device approved for post-traumatic stress disorder treatment. The device will become available to veterans through the VA system beginning summer 2026.
- 131RegulationSource · Medical Design & Outsourcing
FDA device decision timelines get longer as approvals climb, report finds
The FDA approved more medical devices in the first half of 2026 than the prior-year period, but approval timelines have grown substantially longer, according to a BTIG analysis. The analyst noted that while increased approvals signal activity, extended decision times may increase costs and financial risk for device developers navigating the clearance process.
- 132RegulationSource · Medical Device Network
SkylineDX’s predictive melanoma test secures FDA breakthrough designation
SkylineDX received FDA breakthrough device designation for a predictive test that stratifies cutaneous melanoma patients into metastatic risk categories to guide treatment decisions. The test uses patient data to assess progression risk and inform clinical management protocols.
- 133RegulationSource · Medical Device Network
Aurenar wins breakthrough designation for cerebral vasospasm neuromodulation platform
Aurenar received FDA Breakthrough Device designation for its V-Link system, a transauricular vagus nerve stimulation platform designed to modulate brain inflammation in post-stroke patients with cerebral vasospasm. The designation accelerates review pathways for the neuromodulation device.
- 134RegulationSource · 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.
- 135RegulationSource · 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.
- 136RegulationSource · 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.
- 137RegulationSource · 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.
- 138RegulationSource · 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.
- 139RegulationSource · 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.
- 140RegulationSource · 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.
- 141RegulationSource · 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.
- 142RegulationSource · 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.
- 143RegulationSource · 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.
- 144RegulationSource · 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.
- 145RegulationSource · 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.
- 146RegulationSource · 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.
- 147RegulationSource · 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.
- 148RegulationSource · 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.
- 149RegulationSource · 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.
- 150RegulationSource · 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.
- 151RegulationSource · 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.
- 152RegulationSource · 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.
- 153RegulationSource · 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.
- 154RegulationSource · 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.
- 155RegulationSource · 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.
- 156RegulationSource · 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.
- 157RegulationSource · 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.
- 158RegulationSource · 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.
- 159RegulationSource · 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.
- 160RegulationSource · 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.