Regulation — older stories
82 stories beyond the latest 40.
- 041RegulationSource · 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.
- 042RegulationSource · 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.
- 043RegulationSource · 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.
- 044RegulationSource · 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.
- 045RegulationSource · 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.
- 046RegulationSource · 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.
- 047RegulationSource · 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.
- 048RegulationSource · 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.
- 049RegulationSource · 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.
- 050RegulationSource · 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.
- 051RegulationSource · 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.
- 052RegulationSource · 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.
- 053RegulationSource · 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.
- 054RegulationSource · 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.
- 055RegulationSource · 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.
- 056RegulationSource · 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.
- 057RegulationSource · 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.
- 058RegulationSource · 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.
- 059RegulationSource · 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.
- 060RegulationSource · 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.
- 061RegulationSource · 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.
- 062RegulationSource · 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.
- 063RegulationSource · 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.
- 064RegulationSource · 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.
- 065RegulationSource · 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.
- 066RegulationSource · 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.
- 067RegulationSource · 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.
- 068RegulationSource · Medical Device Network
SHINE Technologies receives EU CMA for Ilumira Lu-177 radioisotope
SHINE Technologies obtained a Conditional Marketing Authorization (CMA) from European regulators for Ilumira, its Lu-177 radioisotope product. The clearance permits commercial distribution of the radiopharmaceutical across EU member states. Lu-177 is used in targeted radionuclide therapy for neuroendocrine tumors and other cancers.
- 069RegulationSource · Medical Device Network
SKIA secures FDA 510(k) clearance for AR surgical platform
SKIA, a South Korean medical technology company, received FDA 510(k) clearance for SKIA HEAD, an augmented reality surgical guidance system. The clearance enables the company to market the platform in the US for intraoperative visualization and navigation.
- 070RegulationSource · Medical Device Network
Coredio’s AI heart failure software secures breakthrough designation
Coredio received FDA breakthrough device designation for its AI software that monitors heart failure parameters using wearables and standard blood pressure cuffs. The designation accelerates the review pathway for the software, which analyzes physiological data to support heart failure management.
- 071RegulationSource · Medical Device Network
Procept secures FDA IDE for Aquablation and completes WATER IV study enrolment
Procept BioRobotics received a second FDA Investigational Device Exemption (IDE) to conduct another randomized study of its Aquablation therapy, a minimally invasive procedure for benign prostatic hyperplasia. The company has completed enrollment for the WATER IV study, which will generate additional clinical data to support the technology's regulatory pathway.
- 072RegulationSource · Medical Device Network
Abbott obtains CE mark for duo of glucose-ketone monitors
Abbott obtained CE mark approval for two glucose-ketone monitoring systems designed for diabetic patients. The CE mark clears the devices for distribution in European markets and represents regulatory advancement for Abbott's continuous glucose-ketone sensing portfolio.
- 073RegulationSource · MedCity News
How Bayesian Health’s Sepsis AI Tool Is Decreasing Alerts & Saving Lives
Bayesian Health received FDA clearance for a continuous AI-powered sepsis monitoring system, becoming the first vendor to gain approval for this type of tool. The clearance follows clinical validation and real-world deployments across multiple health systems.
- 074RegulationSource · Medical Device Network
ABILITY Neurotech receives MREC approval for ALS BCI clinical trial
ABILITY Neurotech obtained regulatory approval from the MREC NedMec in the Netherlands to begin a chronic clinical trial of its fully implantable wireless brain-computer interface in ALS patients. The approval clears the path for human testing of the device in a European jurisdiction.
- 075RegulationSource · Mobi Health News
Dexcom discovers two lots of stolen G7 sensors being sold to public
Dexcom identified two lots of G7 continuous glucose monitoring sensors (lot numbers 1725204004 and 1725069002) that were designated as scrap and sent to a third party for destruction, but were instead sold to consumers. The company noted that quality-control rejects are routinely sent to vendors for destruction and recycling as part of standard practice.
- 076RegulationSource · Medical Device Network
CSR secures certifications in EU and Singapore for Sentire system
CSR obtained CE mark certification for its Sentire Endoscopic Surgical System under EU Medical Device Regulation, along with separate approval from Singapore's Health Sciences Authority. The clearances enable market access in both regions for the minimally invasive surgical platform.
- 077RegulationSource · Medical Device Network
Sentante’s endovascular robotic surgery platform secures CE mark
Sentante's endovascular robotic surgery platform has received CE mark approval, clearing the way for commercial deployment across Europe. The company plans to partner with hospitals and healthcare providers to integrate the robotic system into clinical workflows.
- 078RegulationSource · Medical Device Network
Adagio Medical seeks FDA PMA for ventricular ablation system
Adagio Medical submitted a premarket approval application to the FDA for its vCLAS ventricular ablation system, a catheter-based device designed for treatment of ventricular arrhythmias. The PMA filing represents a key regulatory milestone for the company's ablation technology.
- 079RegulationSource · Medical Device Network
OncoSil Medical secures TGA approval for pancreatic cancer device
OncoSil Medical received approval from Australia's Therapeutic Goods Administration (TGA) for its OncoSil device, a pancreatic cancer treatment indicated for use with gemcitabine-based chemotherapy in locally advanced pancreatic cancer (LAPC). The clearance expands the device's regulatory footprint in the Asia-Pacific region.
- 080RegulationSource · Medical Device Network
FDA approves Guardant Health’s next-generation liquid biopsy panel
The FDA approved Guardant Health's Guardant360 Liquid, a next-generation liquid biopsy panel that expands genomic assessment to a 100-fold wider footprint compared to its predecessor, intended to support cancer treatment decisions.