- 161TechnologySource · MedCity News
What’s Flowing Beneath the World Cup: How Verily’s Wastewater Monitoring Could Catch the Next Outbreak
Verily is conducting wastewater pathogen monitoring across World Cup host cities, testing for RSV, measles, norovirus, and other pathogens to detect disease outbreaks five to seven days before clinical presentation. The initiative demonstrates application of environmental surveillance technology for early outbreak detection at large-scale public events.
- 162New productsSource · Medical Design & Outsourcing
Why Remedy Robotics thinks it can win the stroke telesurgery race
Remedy Robotics is positioning its N1 System as a competitive offering in the emerging stroke telesurgery market, joining established OEMs and other startups pursuing robotic remote surgical intervention for acute stroke treatment. The company claims early momentum in a segment seen as a major growth opportunity for medical device vendors.
- 163RegulationSource · Medical Device Network
Penumbra’s Thunderbolt approval poised to accelerate neuro thrombectomy innovation
Penumbra received FDA approval for its Thunderbolt system, the first device to offer CAVT (catheter-assisted vacuum thrombectomy) for stroke intervention. The clearance enables the company to commercialize the neuro thrombectomy device and positions it as the initial market entrant for this intervention modality.
- 164RegulationSource · Medical Device Network
FDA clears SurGenTec’s facet fixation system for degenerative disc disease treatment
The FDA cleared SurGenTec's ION-L facet fixation system for treating degenerative disc disease. The clearance was based on data from an IRB-approved study and positions the device as a less invasive alternative for spinal fixation procedures.
- 165New productsSource · Medical Device Network
Raydiant concludes enrolment in pilot study at LSUHS
Raydiant Oximetry has completed enrolment and data collection for a 15-patient pilot study at Louisiana State University Health Sciences Center. The study evaluates the company's oximetry technology in a clinical setting.
- 166RegulationSource · Medical Device Network
FDA approves Bayer’s Ambelvist contrast agent
The FDA has approved Bayer's Ambelvist, a macrocyclic gadolinium-based contrast agent (mGBCA), for MRI imaging in adults and children, including term neonates. The approval expands the available contrast options for magnetic resonance imaging across pediatric and adult populations.
- 167MarketSource · Medical Device Network
J&J outlays $1bn to strengthen Floridian contact lens manufacturing provision
Johnson & Johnson is investing $1 billion to strengthen its contact lens manufacturing capacity in Florida, specifically for its ACUVUE product line. The capital expenditure aims to enhance supply chain resilience and production capabilities for the contact lens portfolio.
- 168TechnologySource · MedCity News
Where Healthcare Data Systems Fail and How to Build Them Better
An analysis of healthcare data system failures and design approaches to improve interoperability and data tracking across multiple platforms. The piece examines common pitfalls in healthcare IT infrastructure and recommends intentional system architecture strategies to enable better data flow and governance in multi-system environments.
- 169RegulationSource · Medical Device Network
FDA clears Dexcom’s Stelo as first OTC glucose monitor for children
The FDA cleared Dexcom's Stelo continuous glucose monitor (CGM) for over-the-counter use in pediatric patients, making it the first OTC CGM approved for children. The clearance expands the product's indication from adults to include pediatric users with diabetes, enabling direct consumer access without prescription.
- 170RegulationSource · Medical Device Network
FDA oncology roundup: drugs, imaging agents and diagnostics gain approval
The FDA has granted clearances to multiple oncology products including drugs, imaging agents, and diagnostics. The approvals span therapeutics and companion diagnostics, affecting suppliers across imaging, laboratory diagnostics, and related oncology device categories.
- 171New productsSource · Medical Device Network
Dimora Medical introduces MegaSorb technology for advanced wound care
Dimora Medical launched MegaSorb technology for silicone foam dressings, a new wound-care consumable product designed to improve absorption in advanced wound management applications.
- 172New productsSource · Medical Design & Outsourcing
Zeus launches XpanCore mandrels for hypotube assembly
Zeus announced XpanCore, a heat-activated mandrel technology designed to simplify hypotube assembly in catheter manufacturing. The mandrels address liner sizing, placement, and adhesion challenges in advanced catheter production, expanding Zeus's polymer solutions portfolio for medical device manufacturers.
- 173TechnologySource · MedCity News
In the Age of AI, Interoperability Isn’t Enough: Why Healthcare Needs Shared Understanding, Not Just Shared Data
A healthcare industry analysis argues that data interoperability alone is insufficient for AI adoption in medical systems. The piece contends that vendors and health systems need frameworks to translate clinical context into consistent, machine-readable representations across platforms and applications to enable safe, effective AI deployment.
- 174RegulationSource · Medical Device Network
FDA clears Penumbra’s Thunderbolt thrombectomy platform for stroke
The FDA has cleared Penumbra's Thunderbolt thrombectomy platform, a computer-assisted vacuum aspiration system designed for clot removal during acute ischemic stroke treatment. The clearance enables commercial distribution of the device for this indication.
- 175RegulationSource · Medical Device Network
Wave Neuroscience wins FDA clearance for precision PTSD therapy
Wave Neuroscience received FDA clearance for its MeRT platform, which uses transcranial magnetic stimulation (TMS) tailored to individual patient brain data for PTSD treatment. The system records patient-specific neural activity to customize stimulation parameters, enabling personalized therapy delivery.
- 176New productsSource · Medical Design & Outsourcing
Assembled Product Specialists expands cleanroom gowning solutions
Assembled Product Specialists announced an expansion of its cleanroom gowning solutions portfolio, offering comprehensive products designed to improve contamination control, organization, and compliance in laboratory and manufacturing cleanroom environments.
- 177New productsSource · Medical Device Network
First patient treated in Airiver Medical’s RESTORE-2 trial for CRS
Airiver Medical has enrolled the first patient in its RESTORE-2 pivotal trial of the ESSpand Sinus drug-coated balloon (DCB) for chronic rhinosinusitis treatment. The trial will evaluate the device's safety and efficacy in expanding and treating inflamed sinus passages. ESSpand represents a minimally invasive alternative to traditional sinus surgery.
- 178MarketSource · Medical Design & Outsourcing
MGS expands hybrid tooling for faster healthcare development
MGS, a healthcare contract development and manufacturing organization, expanded its hybrid tooling capabilities globally. The offering enables pharmaceutical, diagnostics, and medical device companies to validate product designs under production-like conditions before committing to full-scale manufacturing tooling, aimed at accelerating development timelines and reducing time-to-market.
- 179TechnologySource · MedCity News
Abridge Goes Beyond Documentation: 4 Updates
Clinical AI startup Abridge announced a partnership with Nvidia on foundation models, secured investment from Eli Lilly, and expanded its platform capabilities beyond clinical documentation. The company also signaled plans to address payer-provider workflows. The announcements reflect a shift toward broader clinical decision support and operational integration rather than standalone transcription.
- 180RegulationSource · Medical Design & Outsourcing
A boy’s death is a tragic example of foreseeable risk in device design
A medical device recall involving a hospital bed has resulted in a child fatality, highlighting design flaws that were foreseeable during development. The incident underscores the importance of hazard analysis and risk mitigation in device design for medtech engineers and manufacturers to prevent similar failures in equipment safety and compliance.
- 181TechnologySource · MedCity News
From Copilots to Clinical Judgment: The Next Phase of AI in Digital Behavioral Health
MedCity News discusses the evolution of AI in digital behavioral health platforms beyond basic copilot assistance toward integrated decision-support systems where clinicians, supervisors, and AI collaborate. The shift focuses on building systems that enable human-AI interaction to improve clinical decision-making rather than replacing clinician judgment.
- 182MarketSource · Medical Device Network
How Shockwave Medical plans to keep rivals at bay in burgeoning IVL sector
Shockwave Medical is strengthening its competitive position in the intravascular lithotripsy (IVL) market as rivals explore entry into the sector. The company is pursuing a strategy centered on continued innovation and clinical data generation to defend its market share against emerging competition.
- 183RegulationSource · Medical Device Network
Subtle Medical lands FDA clearance for AI CT imaging software
Subtle Medical received FDA clearance for SubtleHD(CT), an AI software tool designed to enhance CT image quality. The clearance expands the company's portfolio of AI imaging products, which already includes SubtlePET for PET imaging and SubtleHD(MR) for MR imaging enhancement.
- 184RegulationSource · Medical Device Network
FDA clears KARL STORZ’s RUBINA Lens for use in open surgery
KARL STORZ received FDA clearance for its RUBINA Lens exoscope for use in open surgical procedures. The exoscope is a visualization tool that provides magnified, high-definition imaging during open surgery, enabling surgeons to view the operative field with enhanced detail and precision.
- 185MarketSource · Medical Device Network
Podcast: How Shockwave Medical plans to keep rivals at bay in burgeoning IVL sector
Shockwave Medical, the pioneer in intravascular lithotripsy (IVL), is discussing competitive strategy as the sector gains traction and new entrants approach. IVL uses acoustic pulse technology to treat calcified vascular lesions, and Shockwave's early-mover advantage has driven strong adoption. The podcast explores how the company plans to maintain market position amid emerging competition in this growing interventional cardiology segment.
- 186RegulationSource · Medical Device Network
Sibel Health’s ANNE One platform secures EU MDR CE mark
Sibel Health has obtained CE mark certification under the EU Medical Device Regulation for its ANNE One system, which has been classified as a Class IIb medical device. The certification enables the platform to be marketed across the EU.
- 187TechnologySource · Medical Design & Outsourcing
Beyond real-time vitals: Enabling long-term biomarker measurement in wearable optical sensing
ams OSRAM discusses advances in optical sensing technology for wearable devices that extend beyond real-time vital signs to enable long-term biomarker measurement. The article explores how modern wearables capture physiological data including heart rate and blood oxygen, with implications for broader health monitoring applications.
- 188MarketSource · Medical Design & Outsourcing
Gerresheimer expands Georgia plant and makes automation upgrades
Gerresheimer, a German medical device CDMO, has expanded its Peachtree City, Georgia manufacturing facility and installed two automated storage and retrieval systems (AS/RS) to boost production and logistics capacity. The plant manufactures inhalers, infusion components, microinjectors, microbiological test cards, and autoinjectors.
- 189New productsSource · Medical Design & Outsourcing
Medical robotics and AI advice from a J&J DePuy Synthes leader
Johnson & Johnson's DePuy Synthes has launched Velys Hip Navigation with AI Assistance software. A company leader emphasized that AI development should address specific clinical problems rather than pursue the technology for its own sake, advising vendors to consult surgeons on meaningful improvements to patient care workflows.
- 190RegulationSource · Medical Device Network
FDA grants IDE to SpinaFX for study of Triojection
SpinaFX Medical received FDA investigational device exemption (IDE) approval to conduct clinical studies of its Triojection therapy, a spinal intervention device. The IDE clearance permits human investigation of the device as part of the regulatory pathway toward potential market authorization.
- 191MarketSource · Medical Device Network
GT Medical Technologies raises $100m for brain tumour therapy advance
GT Medical Technologies secured $100 million in funding to advance its GammaTile brachytherapy system for brain tumor treatment. The company presented final Phase III clinical data comparing GammaTile against standard of care at the ASCO annual meeting, supporting the device's therapeutic profile and market positioning.
- 192RegulationSource · Medical Device Network
Gore secures CE Mark for venous stent to treat inferior vena cava
Gore obtained CE Mark approval for its Gore Viabahn Fortegra venous stent under the EU Medical Device Regulation. The stent is indicated for symptomatic inferior vena cava and iliofemoral venous outflow obstruction, clearing the device for European market distribution.
- 193MarketSource · Medical Design & Outsourcing
Covestro, Insulectro expand flexible electronics access
Covestro and Insulectro announced a partnership to expand access to advanced film materials and technical support for flexible electronics manufacturers across the Americas. The collaboration targets growing demand in stretchable circuits, wearable devices, medical technologies, and robotics applications.
- 194MarketSource · Medical Design & Outsourcing
WESTPAK adds vacuum decay CCIT testing service
WESTPAK, a contract testing lab serving pharmaceutical and medical device makers for over 40 years, has added Vacuum Decay CCIT (Container Closure Integrity Testing) to its service portfolio. The non-destructive leak detection method provides faster audit-ready results as regulatory requirements tighten. The service supports manufacturers validating sealed containers and closures for drug and device products.
- 195MarketSource · Medical Device Network
Novanta outlays $1.45bn for Riverpoint Medical buyout
Novanta announced the acquisition of Riverpoint Medical for $1.45 billion. The deal expands Novanta's footprint into minimally invasive surgery and strengthens its medical consumables portfolio, representing a significant strategic move to broaden its surgical and procedural device offerings.
- 196New productsSource · Medical Design & Outsourcing
How J&J’s DePuy Synthes developed Velys software for faster hip replacements
Johnson & Johnson's DePuy Synthes launched Velys Hip Navigation with AI Assistance, a software-as-a-medical-device (SaMD) product designed to improve hip replacement surgical efficiency. Developed in-house by the company's digital and robotics surgery team, the platform integrates AI-driven navigation to assist surgeons during hip replacement procedures.
- 197RegulationSource · Medical Device Network
FDA clears Xenix Medical’s Lux fusion system
The FDA has cleared Xenix Medical's Lux fusion system, a spinal fusion surgical device designed to improve procedural success rates and offer greater flexibility after implant placement.
- 198New productsSource · Medical Device Network
Stevanato unveils Deora pen injector for diabetes and weight management
Stevanato Group launched Deora, a multi-use, fixed-dose pen injector for subcutaneous delivery of diabetes and weight-management therapies. The device is positioned for use across multiple drug development programs.
- 199RegulationSource · Medical Device Network
Medtronic secures CE mark for Stealth AXiS system for ENT surgery
Medtronic obtained CE mark approval for its Stealth AXiS surgical system for ENT procedures, enabling market entry across Europe. The system supports image-guided surgery in otolaryngology applications.
- 200RegulationSource · Medical Device Network
FDA issues early alert for GE HealthCare’s infant resuscitation systems
The FDA issued an early alert regarding GE HealthCare's infant resuscitation systems, citing a potential issue with certain blenders that mix air and oxygen to deliver controlled oxygen concentration. The alert affects devices used in neonatal and pediatric critical care settings.