Regulation — older stories
82 stories beyond the latest 40.
- 081RegulationSource · 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.
- 082RegulationSource · 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.
- 083RegulationSource · 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.
- 084RegulationSource · 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.
- 085RegulationSource · 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.
- 086RegulationSource · 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.
- 087RegulationSource · 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.
- 088RegulationSource · 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.
- 089RegulationSource · 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.
- 090RegulationSource · 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.
- 091RegulationSource · 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.
- 092RegulationSource · 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.
- 093RegulationSource · 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.
- 094RegulationSource · 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.
- 095RegulationSource · 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.
- 096RegulationSource · 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.
- 097RegulationSource · 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.
- 098RegulationSource · 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.
- 099RegulationSource · 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.
- 100RegulationSource · 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.
- 101RegulationSource · 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.
- 102RegulationSource · 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.
- 103RegulationSource · 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.
- 104RegulationSource · 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.
- 105RegulationSource · 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.
- 106RegulationSource · 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.
- 107RegulationSource · 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.
- 108RegulationSource · Medical Device Network
enVVeno Medical secures FDA IDE approval for venous valve study
enVVeno Medical received FDA Investigational Device Exemption (IDE) approval to proceed with a pivotal clinical study of its non-surgical venous valve replacement device. IDE approval permits the company to begin human testing as part of the pathway toward broader regulatory clearance.
- 109RegulationSource · MedCity News
Why Some Hospitals Won’t Be Able to Comply With Upcoming HIPAA Updates
The first major HIPAA update in over a decade will eliminate the distinction between required and addressable safeguards, making key cybersecurity and physical security measures mandatory for all healthcare providers. The shift is expected to expose gaps in hospitals' fragmented security systems, according to cybersecurity platform leaders.
- 110RegulationSource · Medical Device Network
Medtronic receives CE mark for Stealth surgical platform
Medtronic received CE mark approval for its Stealth AXiS surgical platform, an integrated system that combines preoperative planning, intraoperative navigation, and robotic guidance capabilities. The clearance enables commercial distribution in European markets.
- 111RegulationSource · Medical Device Network
FDA approves Avatar Medical’s 3D image processing software
Avatar Medical received FDA approval for its 3D image processing software, which converts CT and MR imaging data into three-dimensional models to support surgical planning and OR workflow optimization. The software integrates imaging data to enhance preoperative visualization for surgical teams.
- 112RegulationSource · Medical Device Network
Abbott secures FDA approval for Ultreon 3.0 imaging platform
Abbott received FDA approval and CE Mark for Ultreon 3.0, an AI-powered coronary imaging platform. The clearance enables the company to market the system in the US and European Union for intravascular imaging and analysis applications.
- 113RegulationSource · Medical Device Network
FDA and CMS outline new Medicare coverage pathway for medical device access
The FDA and CMS announced a new pathway designed to accelerate Medicare coverage decisions for medical devices following FDA approval. The initiative aims to streamline the process between regulatory clearance and reimbursement eligibility, reducing the time gap that typically delays device access to Medicare beneficiaries.
- 114RegulationSource · Medical Design & Outsourcing
FDA, CMS unveil accelerated Medicare coverage pathway for breakthrough devices
The FDA and CMS jointly announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway, a new accelerated Medicare coverage mechanism designed to synchronize FDA market authorization with CMS National Coverage Determinations. The initiative aims to reduce delays and streamline reimbursement access for breakthrough medical devices.
- 115RegulationSource · Medical Device Network
J&J secures CE mark for ETHICON 4000 Stapler
Johnson & Johnson obtained CE mark approval for the ETHICON 4000 Stapler, a surgical stapling device designed to maintain staple line integrity across variable tissue thicknesses. The clearance enables commercial distribution in European markets.
- 116RegulationSource · Medical Device Network
FDA grants clearance for Philips’ Rembra scanning platform
Philips received FDA 510(k) clearance for its Rembra platform of scanning systems, which includes the Rembra CT, Rembra RT, and Areta RT models. The clearance enables the vendor to market these imaging devices in the United States.
- 117RegulationSource · Medical Design & Outsourcing
Trelleborg Costa Rica site earns ISO 13485 certification
Trelleborg Medical Solutions' manufacturing facility in Costa Rica has achieved ISO 13485:2016 certification, the international quality management standard for medical device design and manufacturing. The certification demonstrates the site's compliance with process controls and risk management requirements for medical device production.
- 118RegulationSource · Medical Design & Outsourcing
FDA warns device manufacturers of nitrosamine impurities that could cause cancer
The FDA Center for Devices and Radiological Health issued a warning to manufacturers of drug-device combination products alerting them to potential nitrosamine impurities, which are classified as probable carcinogens. The agency did not specify which device types or manufacturers are affected in the letter, but advised vigilance on contamination risks during manufacturing and sourcing of raw materials and components.
- 119RegulationSource · Medical Device Network
Xeltis gains EU CE mark on positive trial data for vascular access graft
Xeltis obtained CE mark approval in the EU for its aXess vascular access graft following positive pivotal trial results. The trial demonstrated 79% secondary patency and 1.3 patency-related reinterventions per patient year, meeting regulatory benchmarks for the hemodialysis access device.
- 120RegulationSource · Medical Design & Outsourcing
PSN Manufacturing earns ISO 9001 and 13485 certifications
PSN Manufacturing, a contract manufacturer of precision components and sub-assemblies for medical devices, has achieved ISO 9001:2015 and ISO 13485:2016 certifications. The dual certifications validate the company's quality management systems and regulatory compliance capabilities, positioning it to serve as a certified contract development and manufacturing organization (CDMO) for medical device suppliers.