- 241RegulationSource · 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.
- 242New productsSource · Medical Device Network
Philips expands ultrasound portfolio with AI-driven Alturion
Philips launched the Alturion ultrasound system, an AI-enabled platform designed for high-volume clinical settings. The system incorporates artificial intelligence-driven workflows to support diagnostic imaging operations.
- 243RegulationSource · 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.
- 244New productsSource · Medical Design & Outsourcing
Why Navigantis thinks it can win the stroke telesurgery race
Navigantis is positioning its VASCO interventional robotic platform as a contender in the emerging stroke telesurgery market. The system is currently in clinical trials for neurointerventional procedures. The company joins established OEMs and early-stage startups competing to enable remote treatment of stroke patients, a segment viewed as a significant opportunity in medical technology.
- 245MarketSource · Medical Device Network
Resmed sharpens sleep care focus with $490m software business sale
ResMed sold MatrixCare, its software business, to private-equity firm Frazier Healthcare Partners for $490 million, less than a decade after acquiring it for $750 million. The divestment reflects ResMed's strategic pivot to concentrate on its core sleep and respiratory care device portfolio.
- 246MarketSource · Medical Device Network
Ottobock expands neuro-orthotics portfolio with Fesia Technology acquisition
Ottobock acquired Fesia Technology to expand its neuro-orthotics offerings. The deal brings Fesia's portfolio of functional electrical stimulation (FES) products used in neurorehabilitation into Ottobock's product line, strengthening its position in the neurological rehabilitation device market.
- 247MarketSource · Medical Device Network
VB Spine to acquire rights to Augmedics’ CT-Fluoro technology
VB Spine has signed a definitive agreement to acquire exclusive rights to Augmedics' CT-Fluoro technology for spine surgery applications. CT-Fluoro combines computed tomography and fluoroscopy imaging to guide surgical procedures. The acquisition expands VB Spine's intraoperative imaging portfolio for spinal intervention.
- 248RegulationSource · 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.
- 249RegulationSource · 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.
- 250MarketSource · Medical Device Network
Alcon spends up to $200m to co-develop customisable cataract lenses with RxSight
Alcon and RxSight announced a co-development partnership valued at up to $200 million to create a tunable presbyopia-correcting intraocular lens (PCIOL) for cataract patients. The collaboration combines Alcon's surgical expertise with RxSight's light-adjustable lens technology to deliver customizable vision correction after implantation.
- 251TechnologySource · Medical Device Network
ALZAI reports validation of Alzheimer’s risk identification models
ALZAI Health announced validation of its AI-driven Alzheimer's disease risk identification models using data from over 1.1 million US patients. The models leverage machine learning to identify individuals at risk of cognitive decline, supporting early detection and intervention pathways in clinical and screening settings.
- 252RegulationSource · 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.
- 253New productsSource · Medical Device Network
Neo Medical launches Instant MIS Access platform in US
Swiss spine surgery company Neo Medical launched its Instant MIS Access platform commercially in the US market. The platform is designed to facilitate minimally invasive surgical access procedures.
- 254TechnologySource · Medical Design & Outsourcing
Researchers say eye-tracking tech can help improve IV pump safety
Researchers at the University of Massachusetts Amherst are using eye-tracking technology to study how nurses interact with intravenous smart pumps, aiming to identify design flaws that contribute to medication errors. The approach offers a method to improve IV pump safety and usability by observing operator behavior during device use.
- 255New productsSource · Medical Device Network
Natera demonstrates MRD test benefit in colorectal cancer patients
Natera presented data demonstrating clinical benefit of its minimal residual disease (MRD) test in colorectal cancer patients at the 2026 ESMO Gastrointestinal Congress in Munich. The test, which detects circulating tumor DNA, showed prognostic value in identifying patients at risk of recurrence. The findings support the diagnostic utility of Natera's MRD assay in post-treatment monitoring of colorectal cancer.
- 256TechnologySource · Medical Device Network
AdaptHealth discloses June cyberattack resulting in patient data exposure
AdaptHealth disclosed a cyberattack in June that exposed patient data after a third-party contractor's credentials were compromised within the company's cloud-based system. The breach highlights supply-chain security risks in cloud infrastructure used by medical equipment and homecare vendors.
- 257New productsSource · Medical Device Network
Over half of target patients enrolled in Xeltis’ aXess US pivotal trial
Xeltis has enrolled over 50% of target patients in its US pivotal trial for aXess, a vascular access device for adults with end-stage renal disease requiring hemodialysis. The milestone marks progress toward regulatory submission for the device.
- 258MarketSource · Medical Device Network
Zydus and Apollo Hospitals sign MoU to launch MCD test in India
Zydus Lifesciences and Apollo Hospitals signed a memorandum of understanding to expand access to Shield, a multi-cancer detection test, across Apollo's hospital network in India. The partnership aims to broaden availability of the cancer screening diagnostic in the Indian market.
- 259RegulationSource · 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.
- 260MarketSource · Medical Device Network
Vivani strikes reverse-merger agreement with ClearOne for BCI business
Vivani Medical has entered a reverse-merger agreement with ClearOne, combining its brain-computer interface (BCI) business with ClearOne to create a publicly listed entity. Upon completion, the combined company will be renamed Cortigent Holdings and will trade on Nasdaq, providing Vivani's BCI technology with public market access.
- 261RegulationSource · 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.
- 262RegulationSource · 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.
- 263New productsSource · Medical Design & Outsourcing
First Look: Boston Scientific’s next-gen Farawave Ultra PFA catheter
Boston Scientific is developing the Farawave Ultra, a third-generation pulsed-field ablation catheter planned for launch in the first half of 2027. The device will expand the Farapulse system portfolio following the January 2024 FDA clearance of the second-generation Farawave PFA catheter. The Ultra variant represents the company's next iteration in the PFA ablation market.
- 264MarketSource · Medical Design & Outsourcing
Zimmer Biomet is adding hundreds of tech jobs in India
Zimmer Biomet plans to hire 500 technical professionals over three years at a new tech center in Bengaluru, India. Positions include software engineering, product design, R&D, quality, regulatory, and finance roles. The expansion reflects the orthopedic and spine device maker's strategy to build engineering and innovation capacity in lower-cost markets.
- 265MarketSource · Medical Device Network
Materna Medical raises $5m for women’s health device portfolio
Materna Medical closed a $5 million funding round to advance its women's health device portfolio. The capital will fund completion of a pivotal trial for its pelvic floor protection system during childbirth, alongside commercial expansion efforts.
- 266TechnologySource · MedCity News
Hospital Networks are Becoming Targets in Cyberwarfare, and They’re Unequipped to Deal With It
Hospital networks face mounting cybersecurity threats from state-sponsored and ideological actors, with healthcare leaders warning that traditional incident-response models are inadequate against adversaries seeking prolonged disruption rather than quick financial gain. The shift toward politically motivated attacks—distinct from ransomware-focused criminal groups—requires hospitals to rethink defense strategies and vendor partnerships around resilience and attribution.
- 267RegulationSource · 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.
- 268New productsSource · Medical Device Network
OrthAlign completes first surgeries with Lantern ASC system
OrthAlign completed initial clinical procedures using its Lantern ASC system, a surgical platform designed for ambulatory surgery center environments. The milestone marks the first in-use validation of the system following development.
- 269New productsSource · Medical Device Network
Hyperfine launches next-generation Swoop MRI system in Europe
Hyperfine has launched the next-generation Swoop portable MRI system (Model 2) in select European markets. The device represents an update to the company's portable MRI platform, expanding its commercial availability beyond the US market.
- 270RegulationSource · 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.
- 271New productsSource · Medical Design & Outsourcing
After selling Endotronix to Edwards, this CEO sees an ‘eye-popping’ cardiac opportunity
VahatiCor, led by CEO Harry Rowland (who previously sold Endotronix to Edwards Lifesciences), is developing the A-Flux reducer system to treat coronary microvascular dysfunction, a condition currently managed only with medication. The device targets patients without existing interventional options for chest pain relief.
- 272RegulationSource · 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.
- 273TechnologySource · Medical Device Network
Nitinol has become central to innovation in ablation therapies
Nitinol material is playing an increasingly central role in electrophysiology ablation catheter design, particularly as pulsed field ablation (PFA) technology gains clinical adoption. The material's properties enable improved precision steering and catheter control in ablation procedures, supporting innovation in the EP ablation market.
- 274RegulationSource · 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.
- 275RegulationSource · 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.
- 276MarketSource · Medical Device Network
Zimmer Biomet to acquire iovera device from Pacira for $140m
Zimmer Biomet agreed to acquire Pacira BioSciences' iovera device, a drug-free pain management system, for up to $140 million. The transaction expands Zimmer Biomet's portfolio in the orthopedic and pain-relief device space.
- 277RegulationSource · Medical Device Network
Novocure receives CE mark for Optune Pax 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.
- 278RegulationSource · Medical Device Network
FDA clears Bioness Medical’s neuromodulation system for stroke rehabilitation
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.
- 279New productsSource · Medical Device Network
GE HealthCare introduces upgrade pathways for interventional suite modernisation
GE HealthCare announced upgrade pathways that allow customers with existing interventional suites to transition to new technologies. The initiative is designed to simplify modernization for facilities seeking to refresh their imaging and procedural capabilities in interventional settings.
- 280RegulationSource · Medical Device Network
FDA approves Artivion’s AMDS device PMA
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.