Regulation — older stories
188 stories beyond the latest 40.
- 081RegulationSource · Medical Device Network
Lantheus Holdings’ Alzheimer’s radiodiagnostic secures FDA approval
Lantheus Holdings received FDA approval for a radiodiagnostic agent designed to identify cognitive impairment associated with tau neurofibrillary tangle pathology in Alzheimer's disease. The diagnostic imaging agent enables visualization and detection of tau pathology in patients with cognitive decline.
- 082RegulationSource · Medical Device Network
FDA selects Cadence’s HypertensionOS as second TEMPO pilot participant
The FDA has selected Cadence's HypertensionOS software as the second participant in its TEMPO (Total Product Life Cycle Advisory for Digital Health Devices) Pilot program. TEMPO provides premarket guidance and accelerated pathways for digital health devices, signaling regulatory momentum for software-based cardiovascular management tools.
- 083RegulationSource · Medical Device Network
Samsung enters OTC hearing aid space with FDA clearance for Galaxy earbud feature
Samsung received FDA clearance for a hearing aid feature in its Galaxy Buds, enabling the company to compete in the over-the-counter hearing aid market alongside Apple's AirPods. The clearance marks Samsung's entry into a newly accessible medical device category.
- 084RegulationSource · Medical Device Network
Distalmotion receives FDA 510(k) clearance for Dexter robotic system
Distalmotion received FDA 510(k) clearance for its Dexter robotic surgery system, enabling the platform for ventral hernia repair procedures. The clearance expands the company's market access for robotic-assisted surgical applications.
- 085RegulationSource · Medical Device Network
FDA clears Vesalio’s latest mechanical thrombectomy device
The FDA cleared Vesalio's pVasc NET, a mechanical thrombectomy device designed to capture and retain clot fragments during retrieval procedures. The device integrates clot-capture technology to improve safety and efficacy in thrombectomy interventions.
- 086RegulationSource · Medical Device Network
Freenome’s lung cancer test receives FDA breakthrough status
Freenome received FDA breakthrough device designation for SimpleScreen Lung, a blood-based test for lung cancer screening in adults. Breakthrough status expedites review of devices that address unmet medical needs and offer potential advantages over existing alternatives.
- 087RegulationSource · Medical Device Network
Wandercraft’s self-balancing exoskeleton wins FDA clearance
Wandercraft received FDA clearance for its self-balancing exoskeleton designed to support upright movement in paralyzed patients. The company plans to launch the device in the US market in September 2026.
- 088RegulationSource · Medical Device Network
Zepto Life Technology wins $8.9m NIH contract for fungal infection panel
Zepto Life Technology secured an $8.9 million contract from the National Institute of Allergy and Infectious Diseases (NIAID) to advance its fungal infection diagnostic panel. The award follows the panel's FDA breakthrough device designation in June 2026, recognizing potential clinical advantages in rapid fungal pathogen identification.
- 089RegulationSource · Medical Device Network
Bracco’s VueJect contrast system secures FDA and Health Canada approvals
Bracco Imaging received FDA 510(k) clearance and Health Canada authorization for its VueJect contrast delivery system. The device enables automated injection of contrast media during medical imaging procedures. The approvals expand Bracco's contrast-delivery portfolio in North American markets.
- 090RegulationSource · Medical Device Network
Elevation Spine lands FDA clearance for expandable interbody fusion system
Elevation Spine received FDA clearance for Saber-XA, an expandable interbody fusion system for spinal surgery. The clearance follows the company's July approval of the Saber-C AVIA cervical fixation device, expanding its portfolio of spinal fusion solutions.
- 091RegulationSource · Medical Device Network
Acarix secures approval in UAE for CADScor system
Acarix has obtained regulatory approval for its CADScor system in the United Arab Emirates, enabling commercial distribution of the device in the region. CADScor is a non-invasive diagnostic system for coronary artery disease assessment.
- 092RegulationSource · MedCity News
How CMS Is Tackling ‘Coverage Purgatory’ for Medical Devices
CMS announced details of its new RAPID pathway, designed to accelerate Medicare coverage decisions for breakthrough medical devices following FDA approval. The initiative addresses a longstanding industry challenge where devices can languish in coverage limbo for years after regulatory clearance, with generally positive industry reception.
- 093RegulationSource · Medical Device Network
Labcorp’s advanced melanoma CDx secures FDA approval
Labcorp received FDA approval for a companion diagnostic (CDx) test that detects BRAF V600E and V600K mutations in melanoma patients to identify candidates for BRAF inhibitor therapy. The test enables treatment selection for eligible patients.
- 094RegulationSource · Medical Device Network
Co-Diagnostics files FDA 510(k) for flu and RSV PCR test
Co-Diagnostics filed a Dual 510(k) premarket notification with the FDA for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test. The filing seeks clearance for a molecular diagnostic assay capable of detecting influenza A, influenza B, and respiratory syncytial virus from upper respiratory specimens in a single test.
- 095RegulationSource · Medical Device Network
Health Canada approves Kardium’s Globe pulsed field system
Health Canada has approved Kardium's Globe pulsed field system, an integrated cardiac mapping and ablation platform. The clearance marks regulatory authorization for the device in the Canadian market.
- 096RegulationSource · Medical Device Network
Medtronic’s ablation system lands ventricular arrhythmia indication expansion in Europe
Medtronic's ablation system has received a regulatory indication expansion in Europe for ventricular arrhythmia treatment. The company is also generating clinical data to support a similar FDA clearance in the US for the same indication.
- 097RegulationSource · Medical Device Network
BlueWind Medical lands FDA clearance for UUI implant with 15-year lifespan
BlueWind Medical received FDA clearance for Revi Extend, an implantable neuromodulation device for urgency urinary incontinence (UUI) with a 15-year battery lifespan. The company plans to begin limited U.S. market launch in Q4 2026.
- 098RegulationSource · Medical Device Network
Natera seeks Japan’s PMDA approval for Signatera test in MIBC
Natera submitted a regulatory application to Japan's PMDA (Pharmaceuticals and Medical Devices Agency) for approval of its Signatera test as a companion diagnostic for muscle-invasive bladder cancer (MIBC). The test is designed to detect circulating tumor DNA and inform treatment decisions in this patient population.
- 099RegulationSource · Medical Device Network
Galaxy Therapeutics secures CE mark for embolisation system
Galaxy Therapeutics obtained CE mark approval for its saccular endovascular aneurysm lattice (SEAL) embolisation system. The company plans a phased commercial rollout across select European markets following the regulatory clearance.
- 100RegulationSource · Medical Device Network
FDA grants 510K clearance for DeepHealth’s AI breast ultrasound technology
DeepHealth received FDA 510(k) clearance for DeepHealth Breast Ultrasound, an AI-based tool designed to assist in breast ultrasound imaging analysis. The clearance enables the company to market the software as a medical device in the US.
- 101RegulationSource · Medical Device Network
FDA clears Total Flow Medical cannula for cardiopulmonary bypass
Total Flow Medical received 510(k) FDA clearance for its femoral arterial cannula designed for cardiopulmonary bypass procedures. The clearance enables the company to market the device for use in cardiac surgery applications requiring extracorporeal circulation support.
- 102RegulationSource · MedCity News
A New Era of Interoperability, But Who Gets Left Behind?
CMS has introduced a new interoperability framework that requires healthcare vendors to meet baseline standards for network participation, though implementation is phased rather than immediate. The policy raises questions about which vendors may struggle to comply with the technical requirements, potentially affecting market entry and competitive dynamics in health IT systems.
- 103RegulationSource · Medical Device Network
FDA grants 510(k) clearance for Elevation Spine’s Saber-C AVIA device
Elevation Spine received FDA 510(k) clearance for the Saber-C AVIA, a cervical fixation device designed for spinal surgery. The clearance enables the company to market the device in the United States.
- 104RegulationSource · Medical Device Network
CorVista wins FDA clearance for AI heart failure assessment add-on
CorVista received FDA clearance for an AI-based pulmonary capillary wedge pressure assessment add-on for heart failure evaluation. This marks the company's third FDA clearance for its cardiopulmonary platform, expanding its diagnostic software capabilities in cardiac assessment.
- 105RegulationSource · Medical Device Network
Patient enrolment concludes in Glaukos’ Preserflo MicroShunt trial
Glaukos has completed patient enrolment in its US 510(k) pivotal trial for the Preserflo MicroShunt, a drainage device designed to treat primary open-angle glaucoma in adults. The trial conclusion marks a milestone toward potential FDA clearance of the device.
- 106RegulationSource · Medical Device Network
Roche’s vaginal infection test obtains FDA clearance
Roche obtained FDA clearance for its cobas assay, a diagnostic test designed to identify bacterial vaginosis and candida vaginitis. The test expands Roche's molecular diagnostics portfolio for gynecological infections.
- 107RegulationSource · Medical Device Network
FDA grants 510(k) clearance to Velmeni for V4D 3D software
Velmeni received FDA 510(k) clearance for V4D, a 3D software platform designed for dental practitioners. The clearance enables the company to market the software in the US for dental applications.
- 108RegulationSource · Medical Device Network
Science Corporation begins European rollout of Prima system
Science Corporation received CE mark approval from DEKRA for its Prima brain-computer interface device under EU Medical Device Regulation and has begun commercial rollout in Europe. The approval clears the pathway for market distribution across EU member states.
- 109RegulationSource · Medical Device Network
J&J MedTech jumps into surgical robot game as OTTAVA secures FDA nod
Johnson & Johnson's MedTech division secured FDA de novo clearance for Ottava, its surgical robotics platform. The company plans an initial launch with select customers, marking J&J's entry into the competitive surgical robotics market.
- 110RegulationSource · Medical Device Network
Philips secures FDA clearance for SpO₂ clip sensor
Philips received 510(k) FDA clearance for a next-generation reusable SpO₂ (blood oxygen saturation) clip sensor. The device enables non-invasive patient monitoring and represents a product iteration within Philips's portfolio of patient monitoring solutions.
- 111RegulationSource · Medical Design & Outsourcing
Noninvasive sepsis SaMD developed at Johns Hopkins offers early warnings
Bayesian Health commercialized a noninvasive sepsis monitoring software as a medical device (SaMD) developed at Johns Hopkins University and received FDA clearance. The AI/ML-based system is the first continuous sepsis monitoring platform of its kind to earn clearance and reportedly detects sepsis hours earlier than conventional clinical assessment.
- 112RegulationSource · Medical Device Network
Newronika’s aDBS system secures CE mark with cloud data integration
Newronika obtained CE mark approval for its αDBS adaptive deep brain stimulation system, which includes cloud-based data integration capabilities. The clearance allows commercial distribution of the neurostimulation platform in European markets.
- 113RegulationSource · Medical Device Network
Health Canada authorises Dexcom G7 15 Day CGM
Health Canada has authorized the Dexcom G7 15 Day continuous glucose monitoring system for adults 18 and older with diabetes. The approval expands availability of the device in the Canadian market.
- 114RegulationSource · Medical Device Network
Claria Medical secures FDA De Novo classification for hysterectomy device
Claria Medical received FDA De Novo classification and marketing authorization for its Claria System, a device that supports tissue extraction during minimally invasive hysterectomy procedures. De Novo classification establishes a new regulatory pathway for the device type.
- 115RegulationSource · Medical Device Network
HistoSonics’ Edison histotripsy system obtains CE mark
HistoSonics announced CE mark approval for its Edison histotripsy system, a therapeutic ultrasound device for liver tumour treatment. The company plans a phased commercial rollout across European centres of excellence specialising in hepatic oncology.
- 116RegulationSource · Medical Device Network
FDA clears Zeta Surgical’s robotic TMS navigation system
The FDA has cleared Zeta Surgical's robotic navigation system for transcranial magnetic stimulation (TMS), a non-invasive brain stimulation technique used to treat depression, behavioral disorders, and addiction-related conditions. The robotic system enhances precision and consistency in TMS coil placement and targeting during treatment delivery.
- 117RegulationSource · Medical Design & Outsourcing
Sentante has a CE mark, its CEO says much more to come for endovascular robotics
Sentante, a developer of remote endovascular robotics systems, obtained CE mark approval in May, clearing the way for commercial deployment in Europe. The company's CEO stated the clearance positions Sentante to move into commercialization and deliver the robotic platform to clinicians.
- 118RegulationSource · Medical Device Network
FDA clears iHealthScreen’s AI diabetic retinopathy screening software
iHealthScreen received FDA clearance for AI software that analyzes diabetic retinopathy from images captured by the iCare DRSplus camera, a device already deployed in US ophthalmology clinics and optician practices. The clearance enables the software to support screening workflows in existing imaging environments.
- 119RegulationSource · Medical Device Network
Roche secures CE Mark for Elecsys test to detect tuberculosis
Roche obtained CE Mark approval for its Elecsys IGRA TB blood-based test, which detects latent tuberculosis infection in routine laboratory settings. The test is now cleared for use in European markets.
- 120RegulationSource · Medical Device Network
TRiCares begins US IDE pivotal trial of TTVR system
TRiCares SAS has enrolled and treated the first patient in the TRICURE US IDE pivotal study of its Topaz TTVR (transtricuspid valve replacement) system. The trial is progressing toward FDA clearance for the transcatheter device, which addresses tricuspid regurgitation in patients ineligible for conventional surgery.