Regulation — older stories
135 stories beyond the latest 40.
- 041RegulationSource · 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.
- 042RegulationSource · 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.
- 043RegulationSource · 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.
- 044RegulationSource · 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.
- 045RegulationSource · 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.
- 046RegulationSource · 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.
- 047RegulationSource · 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.
- 048RegulationSource · 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.
- 049RegulationSource · 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.
- 050RegulationSource · 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.
- 051RegulationSource · 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.
- 052RegulationSource · 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.
- 053RegulationSource · 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.
- 054RegulationSource · 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.
- 055RegulationSource · 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.
- 056RegulationSource · 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.
- 057RegulationSource · 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.
- 058RegulationSource · 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.
- 059RegulationSource · 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.
- 060RegulationSource · 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.
- 061RegulationSource · 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.
- 062RegulationSource · 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.
- 063RegulationSource · 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.
- 064RegulationSource · 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.
- 065RegulationSource · 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.
- 066RegulationSource · 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.
- 067RegulationSource · 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.
- 068RegulationSource · Medical Device Network
Johnson & Johnson’s DE STSF platform secures FDA approval
Johnson & Johnson received FDA approval for its Dual Energy Thermocool Smarttouch SF Platform (DE STSF), a radiofrequency ablation system. The platform is designed for cardiac arrhythmia treatment and incorporates dual-energy technology with the company's Smarttouch contact-force sensing capability.
- 069RegulationSource · Medical Design & Outsourcing
FDA releases draft MDUFA VI agreement outlining proposed legislation and program changes
The FDA released a draft Medical Device User Fee Amendments (MDUFA) VI commitment letter outlining proposed changes to its device review program. The draft includes a faster pre-submission track, earlier communication for de novo applicants, and a new international harmonization pilot program. MDUFA VI represents the agency's reauthorization agreement with the medtech industry.
- 070RegulationSource · Medical Device Network
First patient enrolled in AtaCor’s ALARION-EV trial of EV-ICD system
AtaCor Medical has enrolled the first patient in its ALARION-EV pivotal trial, evaluating an investigational extravascular implantable cardioverter-defibrillator (EV-ICD) system. The trial represents a key regulatory milestone toward potential FDA clearance for the device, which aims to offer an alternative to traditional transvenous ICD implantation.
- 071RegulationSource · Medical Device Network
Beckman Coulter’s Alzheimer’s blood test obtains CE mark
Beckman Coulter received CE mark approval for a blood-based assay measuring phosphorylated tau (pTau217) levels in patients with cognitive decline. The test enables earlier detection and monitoring of Alzheimer's disease through a minimally invasive diagnostic approach.
- 072RegulationSource · Medical Device Network
NICE greenlights first non-invasive endometriosis diagnostic tools
The UK's National Institute for Health and Care Excellence (NICE) has approved two non-invasive endometriosis diagnostic tools—EndoSure and Ziwig Endotest—for use in NHS clinical practice as complementary diagnostics alongside standard evaluation. The clearance marks the first regulatory endorsement of non-invasive diagnostics for endometriosis in the UK market.
- 073RegulationSource · Medical Device Network
FDA clears Visby Medical’s at-home Covid-19 and Influenza PCR test
Visby Medical received FDA clearance for an at-home PCR test that detects both COVID-19 and influenza, delivering results within 30 minutes. The multiplex assay enables patients to self-test and differentiate between the two respiratory viruses without laboratory infrastructure.
- 074RegulationSource · Medical Device Network
Median Technologies receives CE marking for eyonis LCS
Median Technologies received CE marking for eyonis LCS, an AI-based software-as-a-medical-device platform, under the European Medical Device Regulation. The clearance enables commercial distribution of the software in EU markets.
- 075RegulationSource · MedCity News
This Ear-Based Device Could Save Patients from Brain Bleed Complications
Aurenar's V-Link, a non-invasive ear-based nerve stimulation device designed to prevent complications from brain hemorrhage, received FDA breakthrough device designation following early-stage trials that demonstrated greater than 40% reduction in cerebral vasospasm. The designation accelerates the device's regulatory pathway toward clearance.
- 076RegulationSource · Medical Device Network
MHRA investigation leads to convictions in counterfeit baby feeding devices case
The UK Medicines and Healthcare products Regulatory Agency (MHRA) investigation resulted in convictions against Medicina for supplying counterfeit baby feeding devices with false CE markings to NHS Trusts and other UK healthcare providers. The case highlights enforcement action against non-compliant medical device vendors in the infant nutrition supply chain.
- 077RegulationSource · MedCity News
FDA Clears First Neurostimulation Device for PTSD
Neurovalens received FDA clearance for Modius Spero, the first neurostimulation device approved for post-traumatic stress disorder treatment. The device will become available to veterans through the VA system beginning summer 2026.
- 078RegulationSource · Medical Design & Outsourcing
FDA device decision timelines get longer as approvals climb, report finds
The FDA approved more medical devices in the first half of 2026 than the prior-year period, but approval timelines have grown substantially longer, according to a BTIG analysis. The analyst noted that while increased approvals signal activity, extended decision times may increase costs and financial risk for device developers navigating the clearance process.
- 079RegulationSource · Medical Device Network
SkylineDX’s predictive melanoma test secures FDA breakthrough designation
SkylineDX received FDA breakthrough device designation for a predictive test that stratifies cutaneous melanoma patients into metastatic risk categories to guide treatment decisions. The test uses patient data to assess progression risk and inform clinical management protocols.
- 080RegulationSource · Medical Device Network
Aurenar wins breakthrough designation for cerebral vasospasm neuromodulation platform
Aurenar received FDA Breakthrough Device designation for its V-Link system, a transauricular vagus nerve stimulation platform designed to modulate brain inflammation in post-stroke patients with cerebral vasospasm. The designation accelerates review pathways for the neuromodulation device.