Regulation — older stories
188 stories beyond the latest 40.
- 161RegulationSource · 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.
- 162RegulationSource · 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.
- 163RegulationSource · 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.
- 164RegulationSource · 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.
- 165RegulationSource · 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.
- 166RegulationSource · 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.
- 167RegulationSource · 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.
- 168RegulationSource · 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.
- 169RegulationSource · 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.
- 170RegulationSource · 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.
- 171RegulationSource · 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.
- 172RegulationSource · 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.
- 173RegulationSource · 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.
- 174RegulationSource · 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.
- 175RegulationSource · 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.
- 176RegulationSource · 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.
- 177RegulationSource · 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.
- 178RegulationSource · 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.
- 179RegulationSource · 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.
- 180RegulationSource · 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.
- 181RegulationSource · 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.
- 182RegulationSource · 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.
- 183RegulationSource · 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.
- 184RegulationSource · 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.
- 185RegulationSource · 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.
- 186RegulationSource · 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.
- 187RegulationSource · Medical Device Network
Sunrise Group secures FDA clearance for home sleep test
Sunrise Group obtained FDA clearance for Sunrise Air, a rechargeable at-home sleep diagnostic device. The clearance permits the company to market and distribute the device in the US for home-based sleep testing.
- 188RegulationSource · Mobi Health News
UK clears South Korean BP ring and more briefs
South Korean company Sky Labs received UK regulatory clearance from the Medicines and Healthcare products Regulatory Agency for its CART PLATFORM, a blood pressure monitoring system comprising a wearable ring, mobile application, server, and web viewer for clinical use.
- 189RegulationSource · Medical Device Network
Boston Scientific’s coronary IVL catheter hits primary endpoints in trial
Boston Scientific's Seismiq 4CE Coronary catheter, which uses intravascular lithotripsy (IVL) technology, met primary endpoints in its IDE trial. The company plans to file with the FDA based on these results to seek clearance for the device used in coronary interventions.
- 190RegulationSource · Medical Device Network
EmStop begins CAPTURE-2 trial of embolic protection system
EmStop has initiated the CAPTURE-2 IDE clinical trial to evaluate its embolic protection system in transcatheter aortic valve replacement (TAVR) procedures. The trial marks a key regulatory milestone in the development pathway for the device, which is designed to capture emboli during valve replacement interventions.
- 191RegulationSource · Medical Device Network
Valar Labs hits US first with breakthrough designation for AI bladder cancer test
Valar Labs received FDA Breakthrough Device designation for Vesta Bladder Risk Stratify Dx, an AI-powered diagnostic tool that analyzes stained pathology slides to generate risk assessments for bladder cancer patients. The designation is the company's first in the US market.
- 192RegulationSource · Medical Device Network
FDA clears Glooko’s cloud-based insulin dosing platform
The FDA has cleared Glooko's cloud-based insulin dosing platform, a cloud-enabled version of its EndoTool system designed to support broader deployment across hospital settings. The platform enables scalable insulin management across healthcare facilities.
- 193RegulationSource · Mobi Health News
Malaysia OKs Korean AI for sepsis prediction and more AI briefs
AITRICS, a South Korean company, received Class C medical device approval from Malaysia's Medical Device Authority for AITRICS-VC (VitalCare), an AI software that analyzes hospital electronic medical record data to predict patient deterioration and identify sepsis risk. The tool is designed to support faster clinical decision-making and intervention.
- 194RegulationSource · Medical Device Network
AngioDynamics reports PRESERVE trial results for NanoKnife system
AngioDynamics released two-year data from its PRESERVE pivotal trial demonstrating durable outcomes for the NanoKnife irreversible electroporation (IRE) system in intermediate-risk prostate cancer treatment. The trial results support the clinical profile of the device and may inform future regulatory submissions or label claims for the platform.
- 195RegulationSource · Medical Device Network
Revvity secures FDA clearance for total testosterone immunoassay
Revvity received FDA clearance for a total testosterone automated chemiluminescence immunoassay (ChLIA) through its Immunodiagnostic Systems subsidiary. The assay is designed for automated clinical laboratory testing of testosterone levels.
- 196RegulationSource · Medical Device Network
Roche’s Elecsys pTau217 blood test secures CE mark for Alzheimer’s
Roche obtained CE mark for Elecsys pTau217, a blood-based diagnostic test co-developed with Eli Lilly to detect Alzheimer's disease pathology. The test measures phosphorylated tau-217, a biomarker associated with amyloid pathology in the brain, enabling earlier identification of disease in at-risk populations.
- 197RegulationSource · Medical Design & Outsourcing
Lessons learned and FDA TAP tips from a breakthrough device developer
Sentante, developer of a remote endovascular robotics system, was accepted into the FDA's Total Product Life Cycle Advisory Program (TAP) in February 2026 following Breakthrough Device designation. The company shared insights on navigating the FDA's expedited regulatory pathway for novel medical devices.
- 198RegulationSource · Medical Device Network
Bayesian Health secures first FDA clearance for AI-driven continuous sepsis monitor
Bayesian Health received FDA 510(k) clearance for an AI-driven continuous sepsis monitoring system, marking the first FDA approval for this type of early detection technology. The device uses artificial intelligence to identify sepsis indicators in real-time, enabling earlier clinical intervention in intensive care settings.
- 199RegulationSource · Medical Device Network
Biozen secures FDA 510(k) clearance for BP1000 device
Biozen received FDA 510(k) clearance for the BP1000, a cuffless blood pressure measurement device that performs spot readings from the fingertip without calibration. The clearance enables the company to market the device in the US.
- 200RegulationSource · Medical Device Network
Alpha Tau concludes patient enrolment in ReSTART pivotal trial
Alpha Tau Medical has completed patient enrollment in its ReSTART pivotal trial, which evaluates Alpha DaRT for treating recurrent cutaneous squamous cell carcinoma (cSCC). The trial is a key milestone toward potential regulatory clearance of the device.