Regulation — older stories
135 stories beyond the latest 40.
- 121RegulationSource · 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.
- 122RegulationSource · 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.
- 123RegulationSource · 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.
- 124RegulationSource · 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.
- 125RegulationSource · 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.
- 126RegulationSource · 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.
- 127RegulationSource · 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.
- 128RegulationSource · 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.
- 129RegulationSource · 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.
- 130RegulationSource · 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.
- 131RegulationSource · 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.
- 132RegulationSource · 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.
- 133RegulationSource · 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.
- 134RegulationSource · 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.
- 135RegulationSource · 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.
- 136RegulationSource · 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.
- 137RegulationSource · 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.
- 138RegulationSource · 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.
- 139RegulationSource · 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.
- 140RegulationSource · 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.
- 141RegulationSource · 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.
- 142RegulationSource · 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.
- 143RegulationSource · 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.
- 144RegulationSource · 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.
- 145RegulationSource · 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.
- 146RegulationSource · 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.
- 147RegulationSource · 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.
- 148RegulationSource · Medical Device Network
FDA clears Bright Uro’s abdominal sensor for evaluating bladder dysfunction
The FDA cleared Bright Uro's Glean abdominal sensor for evaluating bladder dysfunction. The sensor expands the capabilities of Bright Uro's Glean urodynamics system, which received FDA approval in March 2025. The abdominal sensor component enables non-invasive measurement of abdominal pressure during urodynamic testing.
- 149RegulationSource · Medical Device Network
FDA greenlights Rivanna’s AI musculoskeletal imaging system
The FDA has cleared Rivanna's Accuro XV system, an AI-enabled musculoskeletal imaging platform. The company plans to accelerate development of additional AI capabilities for the system following the clearance.
- 150RegulationSource · Medical Device Network
Glucotrack seeks FDA approval for clinical study of CBGM technology
Glucotrack has submitted an Investigational Device Exemption (IDE) application to the FDA to initiate a clinical study of its continuous blood glucose monitoring (CBGM) technology in the United States. The filing marks a regulatory milestone toward potential market clearance for the glucose monitoring system.
- 151RegulationSource · Medical Device Network
Podcast: The implications of NICE’s formal recommendation for cryoablation’s use in treating kidney tumours
The UK's National Institute for Health and Care Excellence (NICE) has formally recommended cryoablation for treating kidney tumours. Dr David Breen, a consultant abdominal radiologist, discusses the clinical and market implications of this recommendation, which expands the reimbursement and adoption pathway for cryoablation devices in kidney cancer treatment.
- 152RegulationSource · Medical Device Network
Microsure receives CE mark for MUSA-3 system and appoints new CEO
Microsure obtained CE mark approval for its MUSA-3 system and announced Alex Joseph as new chief executive officer, replacing Iwan van Vijfeijken. The CE mark clearance enables the company to market the device in Europe.
- 153RegulationSource · Medical Design & Outsourcing
FDA warns of neurosurgical device shortage after Medline recall
The FDA has added neurosurgical patties, sponges, and strips to its medical device shortage list following a Class 2 recall of Medline Industries neurosurgical sponge products. The agency warned healthcare providers that the shortage could persist through 2026, citing supplier disruptions as the underlying cause.
- 154RegulationSource · Medical Design & Outsourcing
FDA pilots program for more facilities inspections
The FDA has launched a pilot program using artificial intelligence to identify low-risk medical device and manufacturing facilities for streamlined one-day inspectional assessments, both domestically and internationally. FDA Commissioner Marty Makary announced the initiative at the Food and Drug Law Institute Annual Conference, aiming to make inspections more targeted and efficient.
- 155RegulationSource · Medical Device Network
Artera hits US first with pathology-based breast cancer risk tool’s clearance
ArteraAI received US regulatory clearance for ArteraAI Breast, a pathology-based software tool that stratifies breast cancer patients into risk groups to inform treatment decisions. The clearance marks the first such FDA approval for this class of diagnostic software in the US market.
- 156RegulationSource · Medical Device Network
Medtronic’s VitalFlow Transport Frame AG gains CE mark
Medtronic received CE mark clearance for the VitalFlow Transport Frame AG, an accessory to the VitalFlow ECMO system. The frame is designed to support transport and handling of the extracorporeal membrane oxygenation platform in clinical settings.
- 157RegulationSource · Medical Device Network
Italy’s new EFS Guidelines: why Europe’s medtech innovation map just changed
Italy has introduced new early feasibility studies (EFS) guidelines for medical devices, according to analysis from BonelliErede's healthcare regulatory team. The guidelines represent a regulatory shift that affects how medtech innovators conduct preliminary device testing in Europe, potentially reshaping the innovation and approval pathway for vendors seeking to establish clinical evidence in the region.
- 158RegulationSource · Medical Device Network
InspireMD issues voluntary recalls for CGuard Prime device in US
InspireMD issued a voluntary recall of its CGuard Prime 135cm carotid stent delivery system in the US following FDA consultation. The company did not disclose the reason for the recall in the available details.
- 159RegulationSource · Medical Device Network
FDA grants 510(k) clearance to TaeWoong Medical for Spaxus EUS stent
TaeWoong Medical received FDA 510(k) clearance for the Niti-S Spaxus Stent, an endoscopic ultrasound (EUS)-guided therapeutic stent. The clearance enables US commercialization and expands the company's portfolio of EUS-guided interventional solutions for gastroenterology and related specialties.
- 160RegulationSource · Medical Device Network
FDA grants breakthrough status to Capitan Orthopedics’ SupraSpacer implant
The FDA granted breakthrough device designation to Capitan Orthopedics for its SupraSpacer implant, designed to treat irreparable rotator cuff tears. Breakthrough status accelerates the review pathway for devices that address unmet clinical needs and show potential advantages over existing alternatives.