- 201MarketSource · Medical Device Network
MintNeuro and Motif Neurotech collaborate for mental health therapies
MintNeuro and Motif Neurotech have entered a partnership to develop miniature brain-computer interface (BCI) therapy for mental health applications. The collaboration aims to advance BCI technology for therapeutic use, combining the companies' expertise in neural interfaces and neurotech innovation.
- 202TechnologySource · Healthcare IT News
At UToledo Health, ambient AI decreases open charts, improves documentation
University of Toledo Health deployed ambient AI technology to reduce clinician documentation burden and improve EHR efficiency. The implementation decreased open charts and improved documentation workflows, addressing a key pain point in clinical operations where EHR administrative tasks have diverted time from direct patient care.
- 203MarketSource · Medical Device Network
GE HealthCare’s stock plunges 13% as supply chain costs bite
GE HealthCare lowered its 2026 growth forecast, citing rising freight costs and material expenses. The revision, a 3.3 percentage-point reduction at the top end of guidance, prompted a 13% stock decline. The move reflects broader supply chain pressures affecting the medical device manufacturer's outlook.
- 204MarketSource · Medical Device Network
Axoft raises $55m to advance BCI made of Fleuron
Axoft has raised $55 million in funding to advance clinical trials and US regulatory activities for its implantable brain-computer interface (BCI) device. The capital will support ongoing trial programmes and FDA pathway development for the technology.
- 205RegulationSource · Medical Device Network
enVVeno Medical secures FDA IDE approval for venous valve study
enVVeno Medical received FDA Investigational Device Exemption (IDE) approval to proceed with a pivotal clinical study of its non-surgical venous valve replacement device. IDE approval permits the company to begin human testing as part of the pathway toward broader regulatory clearance.
- 206RegulationSource · MedCity News
Why Some Hospitals Won’t Be Able to Comply With Upcoming HIPAA Updates
The first major HIPAA update in over a decade will eliminate the distinction between required and addressable safeguards, making key cybersecurity and physical security measures mandatory for all healthcare providers. The shift is expected to expose gaps in hospitals' fragmented security systems, according to cybersecurity platform leaders.
- 207MarketSource · Mobi Health News
Nervonik raises $52.5M to enhance peripheral nerve stimulation system
Nervonik, a peripheral nerve stimulation device developer, closed a $52.5 million Series B funding round led by Amzak Health. The oversubscribed round included participation from Elevage Medical Technologies, U.S. Venture Partners, Lumira Ventures, Foothill Ventures, and Shangbay Capital. The capital will support enhancement of the company's nerve stimulation platform.
- 208MarketSource · Mobi Health News
Aidoc secures $150M to scale AI imaging tools
Aidoc, an AI imaging software company, closed a $150 million Series E funding round led by Goldman Sachs Growth Equity, with participation from General Catalyst, SoftBank Investment Advisors, and NVIDIA Ventures. The round brings total capital raised to over $500 million. Aidoc develops AI-enabled tools for diagnostic imaging analysis.
- 209MarketSource · Medical Device Network
CareDx sharpens precision medicine focus with $260m Naveris acquisition
CareDx announced a $260 million acquisition of Naveris, a precision medicine company, as part of a strategic shift following the recent divestment of its lab products business. The move reflects CareDx's decision to refocus on precision medicine after its lab segment reported flat Q1 revenue.
- 210TechnologySource · Medical Design & Outsourcing
AI-enabled medtech introduces risks facilities aren’t ready for, cybersecurity report says
A survey of 551 healthcare professionals across the U.S., U.K., and Germany commissioned by RunSafe Security found that nearly 60% expressed high concern about cybersecurity attacks on medical devices, with some organizations reporting incidents that affected patient care. The report highlights that AI-enabled medical devices are introducing security risks that healthcare facilities may be unprepared to manage.
- 211RegulationSource · Medical Device Network
Medtronic receives CE mark for Stealth surgical platform
Medtronic received CE mark approval for its Stealth AXiS surgical platform, an integrated system that combines preoperative planning, intraoperative navigation, and robotic guidance capabilities. The clearance enables commercial distribution in European markets.
- 212RegulationSource · Medical Device Network
FDA approves Avatar Medical’s 3D image processing software
Avatar Medical received FDA approval for its 3D image processing software, which converts CT and MR imaging data into three-dimensional models to support surgical planning and OR workflow optimization. The software integrates imaging data to enhance preoperative visualization for surgical teams.
- 213RegulationSource · Medical Device Network
Abbott secures FDA approval for Ultreon 3.0 imaging platform
Abbott received FDA approval and CE Mark for Ultreon 3.0, an AI-powered coronary imaging platform. The clearance enables the company to market the system in the US and European Union for intravascular imaging and analysis applications.
- 214TechnologySource · MedCity News
6 Things to Know About Medtronic’s Cyberattack
Medtronic disclosed a cyberattack on its corporate IT systems, underscoring rising cybersecurity threats across the medtech sector. The incident involved phishing and social engineering tactics used by cybercriminals to obtain unauthorized access to company data. The attack reflects a broader trend of escalating cyber threats targeting medical device makers and healthcare infrastructure.
- 215New productsSource · Medical Design & Outsourcing
Why Microbot Medical developed a fully disposable surgical robot
Microbot Medical has developed Liberty, a fully disposable single-use surgical robot designed for endovascular navigation procedures. The company designed the system as disposable to address adoption barriers in robot-assisted surgery, particularly extended setup times that have hindered market penetration of reusable robotic systems.
- 216TechnologySource · MedCity News
Why Healthcare AI Still Can’t Scale — and How Nvidia & Hoppr Are Trying to Fix It
Nvidia and Hoppr are developing infrastructure to enable healthcare providers to build and deploy custom AI imaging models, addressing scaling challenges in medical AI adoption. Rather than relying on standalone applications, the approach aims to create a foundational layer that allows organizations to train and operationalize models internally, potentially accelerating broader AI implementation across healthcare systems.
- 217TechnologySource · MedCity News
What Dentistry Is Teaching Healthcare About Operational AI
Dental practices are adopting AI to address operational inefficiencies and tight reimbursement cycles, focusing on measurable administrative impact rather than novelty. The experience offers lessons for broader healthcare operations on practical AI implementation and ROI evaluation in cost-sensitive environments.
- 218TechnologySource · MedCity News
How Recent Changes in ‘Patient-Matched’ Technology Are Reshaping the Future of Surgical Care
Patient-matched medical device technology is shifting clinical practice toward personalized treatments, with manufacturers adapting implants and devices to individual patient anatomy rather than requiring patients to accommodate standard designs. This manufacturing and design evolution reflects a broader move toward customization in surgical care.
- 219TechnologySource · Medical Design & Outsourcing
Kingstec advances real-time medical asset tracking
Kingstec Technologies has implemented Technology Trace Inc.'s trevii platform for real-time medical asset tracking at St. Joseph's Healthcare Hamilton in Ontario. The partnership combines Kingstec's manufacturing and logistics expertise with Technology Trace's asset management software to enable hospitals to track medical equipment and supplies in real time.
- 220TechnologySource · MedCity News
Why Some Hospitals Are Betting on Midstream Health to Help Eliminate Waste
Midstream Health, an AI startup, is helping health systems including Mount Sinai and CommonSpirit identify cost-savings opportunities by analyzing fragmented spending data. The platform focuses on optimizing purchasing decisions and waste reduction across hospital operations rather than revenue generation. The approach targets procurement and supply chain efficiency for large health systems.
- 221TechnologySource · MedCity News
Healthcare’s Identity Crisis: Why A Single Prescription Requires Multiple Logins
Healthcare IT systems lack interoperable identity and access management standards, forcing users to authenticate multiple times across disconnected platforms for routine tasks like prescription processing. Industry experts argue the solution requires phishing-resistant multi-factor authentication, adaptive access controls, and standards-based interoperability frameworks to unify authentication across vendors and health systems.
- 222MarketSource · MedCity News
Beyond the Scale: How Imaging Can Help Determine GLP-1 Efficacy
Telehealth clinic Hone Health partnered with imaging vendor BodySpec to offer DEXA body composition scans to GLP-1 patients. The collaboration aims to help providers differentiate fat loss from muscle loss during treatment, enabling more detailed assessment of drug efficacy beyond weight metrics alone. The partnership represents a vendor strategy move to integrate diagnostic imaging into remote weight-management workflows.
- 223TechnologySource · Healthcare IT News
AI may be approaching a new phase in healthcare, on two fronts
Physicians are adopting agentic AI tools like Claude Code to develop custom clinical applications, marking a shift toward clinician-led software development within health systems. While the approach promises to accelerate app creation, industry experts caution that widespread adoption requires new security audits and professional engineering oversight to address AI-generated vulnerabilities and protect patient data.
- 224TechnologySource · Mobi Health News
Interoperability governance gaps put pressure on nationwide exchange networks
Nationwide health information exchange networks are facing pressure to expand responsibilities beyond their original scope as interoperability demands grow, creating questions about whether existing governance structures can adapt. The gaps in governance frameworks are straining networks' ability to support modern data-sharing requirements across healthcare systems.
- 225MarketSource · Mobi Health News
Courier Health scores $50M to scale CRM technology
Courier Health, a health tech platform serving life sciences manufacturers, closed a $50 million Series B funding round led by Oak HC/FT, with participation from Norwest and Work-Bench. The New York-based company provides CRM technology to help manufacturers manage customer relationships and sales operations.
- 226TechnologySource · Healthcare IT News
New Zealand Telehealth Services to pilot AI support for helplines
Whakarongorau Aotearoa, New Zealand's telehealth services provider, will pilot a Microsoft Azure AI-powered service in May to assist callers during wait times before connecting with healthcare staff. The deployment represents a vendor adoption of cloud-based AI infrastructure to augment helpline operations and improve caller experience in a telehealth setting.
- 227New productsSource · Medical Device Network
Imricor begins US commercial sales of NorthStar mapping system
Imricor Medical Systems has launched commercial sales of its NorthStar Mapping System in the US market. The system is designed for cardiac electrophysiology procedures, enabling real-time mapping and navigation during ablation and other interventional cardiac treatments. The commercial rollout follows regulatory clearance and positions Imricor to compete in the cardiac mapping and navigation device segment.
- 228RegulationSource · Medical Device Network
FDA and CMS outline new Medicare coverage pathway for medical device access
The FDA and CMS announced a new pathway designed to accelerate Medicare coverage decisions for medical devices following FDA approval. The initiative aims to streamline the process between regulatory clearance and reimbursement eligibility, reducing the time gap that typically delays device access to Medicare beneficiaries.
- 229TechnologySource · Mobi Health News
OpenAI launches ChatGPT for Clinicians
OpenAI launched ChatGPT for Clinicians, a large-language-model tool designed for individual healthcare providers to assist with medical research, documentation, and sourced answers. The company positioned it for clinicians at facilities without centralized AI systems, with conversations excluded from model training. The offering represents an entry point for GPT-based AI into point-of-care workflows.
- 230MarketSource · MedCity News
Top Silicon Valley VCs Are Backing a New Health Tech Residency Program
The AI Health Fund launched Treehub, a residency program for early-stage healthcare AI startups, backed by prominent venture investors including Tim Draper and Anne Wojcicki. The program targets companies at pre-formation stages, signaling continued capital flow into the health tech vendor ecosystem.
- 231RegulationSource · Medical Design & Outsourcing
FDA, CMS unveil accelerated Medicare coverage pathway for breakthrough devices
The FDA and CMS jointly announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway, a new accelerated Medicare coverage mechanism designed to synchronize FDA market authorization with CMS National Coverage Determinations. The initiative aims to reduce delays and streamline reimbursement access for breakthrough medical devices.
- 232RegulationSource · Medical Device Network
J&J secures CE mark for ETHICON 4000 Stapler
Johnson & Johnson obtained CE mark approval for the ETHICON 4000 Stapler, a surgical stapling device designed to maintain staple line integrity across variable tissue thicknesses. The clearance enables commercial distribution in European markets.
- 233MarketSource · Medical Device Network
Boston Scientific reports steady Q1 2026 performance yet tempers FY26 outlook
Boston Scientific reported 11.2% year-over-year growth in Q1 2026 but reduced its full-year 2026 revenue guidance, trimming the top-end growth outlook by 2 percentage points. The adjustment signals caution amid what the company characterized as steady near-term performance across its device portfolio.
- 234TechnologySource · Medical Design & Outsourcing
How digitizers power next-generation SS-OCT systems
Advanced digitizers are enabling faster data acquisition in swept-source optical coherence tomography (SS-OCT) systems, supporting higher imaging speeds and improved sensitivity in real-time tissue visualization. SS-OCT's enhanced depth penetration and resolution compared to conventional OCT make digitizer performance critical to next-generation imaging system design.
- 235RegulationSource · Medical Device Network
FDA grants clearance for Philips’ Rembra scanning platform
Philips received FDA 510(k) clearance for its Rembra platform of scanning systems, which includes the Rembra CT, Rembra RT, and Areta RT models. The clearance enables the vendor to market these imaging devices in the United States.
- 236RegulationSource · Medical Design & Outsourcing
Trelleborg Costa Rica site earns ISO 13485 certification
Trelleborg Medical Solutions' manufacturing facility in Costa Rica has achieved ISO 13485:2016 certification, the international quality management standard for medical device design and manufacturing. The certification demonstrates the site's compliance with process controls and risk management requirements for medical device production.
- 237RegulationSource · Medical Design & Outsourcing
FDA warns device manufacturers of nitrosamine impurities that could cause cancer
The FDA Center for Devices and Radiological Health issued a warning to manufacturers of drug-device combination products alerting them to potential nitrosamine impurities, which are classified as probable carcinogens. The agency did not specify which device types or manufacturers are affected in the letter, but advised vigilance on contamination risks during manufacturing and sourcing of raw materials and components.
- 238TechnologySource · MedCity News
Wearable Noise Is Exploding — Trust Is the Filter
Wearable devices are generating unprecedented volumes of health data, but clinicians and payers face growing uncertainty about data reliability and clinical utility. The article examines the challenge of validating wearable outputs for clinical decision-making, reimbursement justification, and patient reassurance, highlighting a critical gap between device proliferation and evidence-based confidence in their outputs.
- 239RegulationSource · Medical Device Network
Xeltis gains EU CE mark on positive trial data for vascular access graft
Xeltis obtained CE mark approval in the EU for its aXess vascular access graft following positive pivotal trial results. The trial demonstrated 79% secondary patency and 1.3 patency-related reinterventions per patient year, meeting regulatory benchmarks for the hemodialysis access device.
- 240MarketSource · Medical Device Network
AcuityMD raises $80m for AI augmentation to medtech sales platform
AcuityMD secured $80 million in funding to expand its AI-powered sales platform serving medical device companies. The platform is designed to streamline commercial execution and sales operations for medtech vendors. The fresh capital will support integration of advanced AI capabilities into the existing system.