- 361MarketSource · 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.
- 362RegulationSource · 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.
- 363MarketSource · 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.
- 364MarketSource · 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.
- 365MarketSource · 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.
- 366New 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.
- 367RegulationSource · 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.
- 368New 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.
- 369RegulationSource · 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.
- 370RegulationSource · 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.
- 371New productsSource · Medical Device Network
ADA26: Dexcom’s G7 CGM helps TD2 diabetics not on insulin manage glucose levels
Dexcom presented data on its G7 continuous glucose monitoring system showing efficacy in type 2 diabetes patients not requiring insulin therapy. The company expects the findings may influence clinical practice patterns for this patient population.
- 372RegulationSource · Medical Device Network
Tandem secures CE mark for AID systems in T2D and T1D with pregnancy
Tandem Diabetes Care obtained CE mark approval for expanded indications of its automated insulin delivery systems, now cleared for use in type 2 diabetes and type 1 diabetes patients who are pregnant. The expanded authorization widens the addressable patient population in European markets for Tandem's AID platform.
- 373TechnologySource · MedCity News
When Geopolitics Becomes a Patient Safety Issue: Protecting Healthcare in an Era of Targeted Cyberattacks
Healthcare organizations face growing cybersecurity threats driven by geopolitical actors seeking disruption rather than ransom, according to analysis of targeted infrastructure attacks. The shift from financially motivated cybercrime to state-sponsored chaos-focused campaigns poses distinct operational and safety risks that most providers are unprepared to address, requiring new defensive strategies and vendor partnerships.
- 374RegulationSource · Medical Device Network
Zepto Life Technology’s mould infection panel obtains FDA breakthrough designation
Zepto Life Technology's FungiFlex mould panel has received FDA Breakthrough Device designation. The panel identifies 14 clinically important mould species using cell-free fungal DNA detection in plasma, enabling faster diagnosis of invasive fungal infections in immunocompromised patients.
- 375MarketSource · Medical Device Network
Sophia Genetics and MSK join forces to develop precision oncology hub
Sophia Genetics and Memorial Sloan Kettering Cancer Center have partnered to develop a precision oncology hub focused on multimodal approaches. The collaboration aims to advance diagnostic and treatment strategies in oncology through combined expertise in genetic analysis and clinical care.
- 376MarketSource · Medical Design & Outsourcing
Cordica Medical acquires RapidWerks micro-molding capability
Cordica Medical, a medical device contract development and manufacturing organization, has acquired RapidWerks' micro-molding capabilities. The acquisition expands Cordica's precision manufacturing capacity for miniaturized medical devices, adding dedicated automated micro-molding for mass production to its integrated design and manufacturing services.
- 377New productsSource · Medical Device Network
Roche develops RUO PCR assay to detect rare Ebola Bundibugyo virus
Roche has developed a research-use-only (RUO) PCR assay for rapid detection of Ebola Bundibugyo virus. The molecular test leverages Roche's existing PCR platform capabilities to address detection of this rare viral variant.
- 378RegulationSource · Medical Device Network
FDA approves GE HealthCare’s MIM Contour ProtégéAI+ 2.0 software
GE HealthCare received FDA 510(k) clearance for MIM Contour ProtégéAI+ 2.0, an AI-powered software tool. The clearance expands GE's portfolio of computational aids for medical imaging and oncology planning workflows, enabling vendors and providers to adopt the updated solution for clinical use.
- 379MarketSource · MedCity News
CereVasc Rakes In $85M to Challenge Traditional Brain Shunt Surgery
CereVasc closed an $85 million Series C funding round to support development of its eShunt system, a minimally invasive alternative to conventional brain shunt surgery for hydrocephalus treatment. The company expects to complete a pivotal clinical trial and submit to the FDA in 2027.
- 380New productsSource · Medical Design & Outsourcing
Edwards Lifesciences makes a simple change for a first-of-its-kind tricuspid valve
Edwards Lifesciences received FDA approval in May 2026 for Triformis Resilia, the first surgical valve designed specifically for the tricuspid position. The device incorporates a design modification that addresses an unmet clinical need in tricuspid valve replacement, marking a new product entry in the structural heart device market.
- 381MarketSource · Medical Device Network
CereVasc raises $85m to advance hydrocephalus treatment
CereVasc raised $85 million to advance development of eShunt, an implantable system for treating normal pressure hydrocephalus through cerebrospinal fluid drainage. The funding supports clinical advancement and commercialization of the device.
- 382MarketSource · Medical Device Network
ResMed completes $340m Noctrix Health acquisition
ResMed completed its acquisition of Noctrix Health for $340 million. Noctrix's lead product, Nidra, is a neuromodulation device targeting peroneal nerves to treat restless leg syndrome symptoms. The deal expands ResMed's portfolio in sleep and respiratory care.
- 383RegulationSource · Medical Device Network
Medtronic seeks FDA clearance for Hugo RAS system
Medtronic has filed with the FDA seeking to expand clearance for its Hugo RAS robotic-assisted surgery system to general and gynaecologic surgery indications. The company submitted multiple regulatory filings to broaden the platform's approved use cases beyond its current scope.
- 384New productsSource · Medical Device Network
Insulet launches algorithm improvements for Omnipod 5 AID system in US
Insulet has begun distributing an updated version of its Omnipod 5 automated insulin delivery system across the US following 510(k) regulatory clearance in December 2025. The update includes algorithm improvements to the closed-loop control system.
- 385TechnologySource · Mobi Health News
AccurKardia receives patent for AI-ECG cardiac amyloidosis detection
AccurKardia received a U.S. patent for an AI-powered system that detects cardiac amyloidosis from standard 12-lead ECGs. The machine learning technology addresses delayed diagnosis in a disease area where early detection is challenging, expanding the company's AI-ECG analytics pipeline.
- 386TechnologySource · Healthcare IT News
Microsoft partners with Mayo Clinic to develop frontier AI model for healthcare
Microsoft and Mayo Clinic announced a partnership to develop an advanced AI model for healthcare applications. The collaboration aims to leverage Mayo's clinical expertise and data with Microsoft's AI infrastructure to build tools that address healthcare workflows. Terms and specific use cases were not detailed.
- 387TechnologySource · Mobi Health News
Microsoft partners with Mayo Clinic to develop frontier AI model for healthcare
Microsoft and Mayo Clinic formed a partnership to develop a frontier AI model for healthcare applications. The model, owned by Mayo Clinic, will integrate the health system's de-identified clinical data and longitudinal insights with Microsoft's AI, engineering, and cloud infrastructure. The collaboration aims to advance AI capabilities in clinical settings by combining clinical expertise with technology infrastructure.
- 388RegulationSource · Medical Design & Outsourcing
FDA rules, regulations and resources for artificial intelligence in medical devices
The FDA has issued guidance on how artificial intelligence and machine learning in medical devices will be regulated. Manufacturers incorporating AI/ML into products must determine regulatory classification and whether the software itself requires separate oversight. The guidance clarifies FDA authority over both device hardware and software components.
- 389TechnologySource · Healthcare IT News
Beyond the screen: How ambient AI is changing the exam room
Beth Israel Lahey Health is implementing ambient AI in exam rooms to reduce physician documentation burden and improve patient engagement. The technology captures and processes clinical conversations without requiring clinicians to maintain eye contact with computer screens during appointments, allowing providers to focus more directly on patients while EHR data is populated automatically in the background.
- 390TechnologySource · Healthcare IT News
New HSCC guide addresses cybersecurity risks specific to healthcare AI
The Healthcare and Public Health Sector Coordinating Council has released new guidance on cybersecurity risks specific to healthcare AI systems. The guide addresses governance and security considerations as providers increasingly deploy AI across clinical and operational workflows, going beyond existing regulatory requirements to help organizations establish effective AI cybersecurity practices.
- 391New productsSource · Medical Device Network
HeartBeam reports positive ECG data in heart attack detection
HeartBeam reported positive study data supporting an indication expansion of its ECG device into heart attack detection. The data advance the scientific foundation for the company's planned product expansion, though specific clinical endpoints and timeline for regulatory submission were not detailed in the announcement.
- 392New productsSource · Medical Device Network
Stryker introduces TPX HD small bone power tool for orthopaedic surgery
Stryker launched TPX HD, a small bone power tool designed for orthopaedic procedures including total joint revisions, minimally invasive surgery, and oral maxillofacial operations. The tool expands Stryker's surgical instrument portfolio for complex bone work.
- 393RegulationSource · Medical Device Network
Philips secures FDA clearance for Elevate Plus AI ultrasound upgrade
Philips received FDA 510(k) clearance for Elevate Plus, a software upgrade that adds imaging and AI capabilities to its EPIQ Elite and Affiniti ultrasound systems. The clearance enables the company to deploy enhanced diagnostic features across its installed base of ultrasound platforms.
- 394MarketSource · MedCity News
Novellia Snags $18M for Its Real-World Data Platform
Novellia raised $18 million in Series A funding to expand its real-world data platform, which enables patients to consolidate medical records and share anonymized data with pharmaceutical companies. The platform aims to improve drug research by sourcing more complete healthcare datasets directly from patient sources.
- 395MarketSource · Mobi Health News
Elation Health acquires Aster to expand AI-enabled EHR capabilities
Elation Health acquired Aster, an EHR startup focused on women's health, to expand its AI-enabled electronic health record capabilities. Elation, a California-based supplier of cloud-based clinical EHRs, telehealth services, and practice management software for primary care providers, added Aster's women's health specialization to its existing portfolio of digital tools for healthcare providers.
- 396New productsSource · Medical Design & Outsourcing
Can surgical robots fly? SSi’s CEO discusses the challenges and solutions
SS Innovations CEO Dr. Sudhir Srivastava outlined plans for a flying surgical robot, the Vimana Aero drone, targeting mid-2026 launch. The company unveiled a conceptual design in April and is working through engineering and regulatory challenges to develop an autonomous aerial platform for surgical applications.
- 397TechnologySource · Healthcare IT News
Epic integrates firearm injury risk screening tool from Northwell Health
Epic Systems has integrated a firearm injury risk screening tool developed by Northwell Health into its EHR platform. The tool enables clinicians to identify patients at elevated risk during clinical encounters. The integration expands access to the screening capability across Epic's user base of healthcare systems and providers.
- 398MarketSource · Medical Device Network
Subtle Medical raises $33m, appoints new CEO to advance AI image software
Subtle Medical closed a $33 million Series C funding round and appointed industry veteran Ohad Arazi as CEO to lead global commercialization of its AI imaging software. The company develops artificial-intelligence tools for medical image processing and analysis.
- 399RegulationSource · Medical Design & Outsourcing
FDA picks Nephrodite’s implantable dialysis system for TAP pilot
Nephrodite's Holly implantable continuous dialysis system has been selected for the FDA's Total Product Life Cycle Advisory Program (TAP) pilot. The device previously received FDA Breakthrough Device Designation. The TAP program is designed to expedite patient access to innovative medical devices through enhanced regulatory guidance and support.
- 400RegulationSource · Medical Device Network
Podcast: Assessing the EMA’s new innovative medical device pathway pilot
The European Medicines Agency has launched a pilot programme offering expert support to manufacturers developing breakthrough medical devices through a new innovative device pathway. The initiative is designed to streamline regulatory review and guidance for qualifying emerging technologies, potentially accelerating time to market for novel solutions.