Curated from medtech publications. Product launches, FDA clearances, M&A, technology shifts — rewritten as short briefs, linked back to the source. Filter by theme below.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Novocure received CE Mark approval for Optune Pax, a portable device designed to treat adults with locally advanced exocrine pancreatic cancer. The clearance enables the company to market the device in the European Union and other regions that recognize CE certification.
The FDA has cleared Bioness Medical's PoNS (Portable Neuromodulation Stimulator) system for stroke rehabilitation. The device uses neuromodulation to stimulate the trigeminal and facial cranial nerves, targeting improvement of gait impairment in stroke patients. The clearance expands the therapeutic applications available to rehabilitation providers and hospitals treating post-stroke motor dysfunction.
Artivion received FDA PMA clearance for its AMDS Hybrid Prosthesis device, indicated for treatment of acute DeBakey Type I aortic dissections with clinical or radiographic malperfusion. The approval permits commercial distribution in the US market.
UpDoc obtained FDA 510(k) clearance for a software-as-a-medical-device platform that integrates patient-facing large language models for clinical use, marking what the company claims is the first such FDA-cleared SaMD of its kind. The clearance signals regulatory acceptance of LLM-based clinical AI tools and may establish a pathway for similar developers.
The FDA has granted breakthrough device designation to Aidoc's First Read, an AI system that generates preliminary radiology report text from chest radiograph analysis. Breakthrough status expedites the FDA review pathway for devices addressing unmet clinical needs or offering significant advantages over existing alternatives.
The FDA announced it will reject all data from studies conducted at three Chinese third-party testing facilities due to unreliable or falsified data. The enforcement actions, part of an ongoing crackdown, affect labs that have submitted invalid or compromised test results since 2024. The rejections will impact device manufacturers relying on these facilities for safety and performance validation needed for FDA submissions.
BrightHeart obtained CE mark approval for its B-Right AI platform, an artificial intelligence system designed for prenatal ultrasound analysis. The certification enables the company to expand the technology into European markets while continuing its US rollout.
Quest Diagnostics received approval from the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) for its Haystack minimal residual disease (MRD) test, enabling broader clinical use across the United States. The test detects residual cancer cells in patient samples post-treatment.
PorTal Access received FDA clearance for its FLEXI-PORT family of vascular access devices, designed to offer flexibility and versatility in vascular access applications. The clearance expands the company's portfolio of vascular access solutions for clinical use.
Masimo received FDA 510(k) clearance for an opioid-induced respiratory depression (OIRD) detection feature on its Radius VSM wearable patient monitor. The clearance enables the device to detect and alert clinicians to respiratory depression associated with opioid use in monitored patients.
Abiomed reported eight cases of major bleeding associated with leakage in Impella heart pump introducer kits, including three deaths, triggering an FDA safety alert. The company disclosed the issue through regulatory channels as part of ongoing device surveillance.
Novocure announced that its Phase III TRIDENT study failed to demonstrate statistical significance in overall survival when Optune Gio was used at an earlier disease stage. The result suggests the device does not provide benefit in this earlier-stage indication, likely impacting the company's development strategy and regulatory pathway for expanded labeling.
FiberSense has obtained CE mark approval for its continuous glucose monitoring (CGM) device, which uses optical sensor technology to measure glucose in subcutaneous tissue fluid. The company plans next steps toward commercial readiness following the regulatory clearance.
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