- 121TechnologySource · MedCity News
Why Generative AI Isn’t Enough: The Case for Causal Reasoning in Medicine
An analysis examines the limitations of generative AI in clinical settings and advocates for causal-reasoning systems that provide transparent, mechanism-based outputs grounded in validated biology. The piece argues that explainability and source citation are essential for maintaining clinical trust in AI-driven medical tools, distinguishing transparent reasoning systems from black-box generative models.
- 122RegulationSource · Medical Device Network
FDA grants breakthrough status to Aidoc’s AI radiology report system
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.
- 123TechnologySource · Medical Device Network
Clariyon’s AI tool boosts sepsis care compliance in hospital study
Clariyon released clinical-trial data showing its AI tool improved physician compliance with sepsis-care protocols in hospital settings. The timing coincides with rising adoption of AI decision-support systems in acute care, where sepsis affects 1.7 million US adults annually. The tool is designed to standardize evidence-based sepsis management workflows.
- 124New productsSource · Medical Device Network
J&J starts SKYWARD study of carotid IVL system
Johnson & Johnson has begun enrollment in the SKYWARD IDE clinical study to evaluate the Shockwave SkyRunner Carotid IVL (Intravascular Lithotripsy) system. The trial will assess the device's safety and effectiveness for treating calcified carotid artery disease.
- 125RegulationSource · Medical Design & Outsourcing
FDA warns it will reject test results from three third-party labs due to ‘unreliable’ data
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.
- 126MarketSource · Medical Design & Outsourcing
Ex-Medtronic CEO Bill Hawkins joins Ketryx board
Bill Hawkins, retired Medtronic chair and CEO, has joined the board of Ketryx, a regulatory software platform for life sciences companies. Hawkins noted in a statement that medtech leaders are seeking ways to leverage AI to accelerate safe innovation, signaling growing industry interest in regulatory automation tools.
- 127MarketSource · Medical Device Network
Merck KGaA to buy Bio-Techne for $11.3bn in life science footprint expansion
Merck KGaA announced an $11.3 billion acquisition of Bio-Techne, a life sciences company, marking its largest deal since the 2015 purchase of Sigma-Aldrich for $17 billion. The transaction expands Merck's portfolio in research reagents, instruments, and related life science tools supplied to labs and medical institutions.
- 128MarketSource · Medical Device Network
Advanced Medical Solutions mulls £715m HB Fuller takeover bid
Advanced Medical Solutions is considering a £715 million acquisition of HB Fuller, which the companies say would expand the combined addressable market by $15 billion and add approximately $300 million in annual revenue. The deal represents a significant consolidation move within the medical equipment and supplies sector.
- 129TechnologySource · Medical Device Network
Oracle Health and Theator partner to offer AI surgical intelligence in US
Oracle Health has partnered with Theator to deliver AI-powered surgical intelligence solutions to its US customer base. The collaboration integrates Theator's AI platform with Oracle Health's infrastructure, enabling real-time surgical workflow analysis and optimization for operating room teams.
- 130RegulationSource · Medical Device Network
BrightHeart secures CE mark for AI-powered prenatal ultrasound platform
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.
- 131RegulationSource · Medical Device Network
Quest Diagnostics’ Haystack MRD test secures NYSDOH approval
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.
- 132New productsSource · Medical Design & Outsourcing
MIT researchers develop an ingestible temperature sensor the size of a blueberry
MIT researchers have developed a miniaturized ingestible temperature sensor (MITS) measuring 4 mm tall and 6 mm wide—roughly blueberry-sized—designed to continuously monitor core body temperature from the gastrointestinal tract. The device is smaller than existing ingestible temperature sensors, reducing swallowing difficulty and aspiration risk. The advancement addresses a gap in non-invasive continuous core temperature monitoring for clinical and research applications.
- 133New productsSource · Medical Device Network
MGS Launches Hybrid Tooling to Accelerate Global Healthcare Product Development
MGS launched hybrid tooling technology to accelerate injection-molded prototyping and validation for medical device manufacturers. The offering enables faster development cycles and reduces manufacturing risk by supporting global healthcare product development workflows.
- 134TechnologySource · Medical Design & Outsourcing
MIT researchers develop 3D-printed electronic nozzles for precise drug delivery
MIT researchers developed 3D-printed triaxial electrospray emitters that use electrical pulses to dispense three liquids simultaneously, forming multilayered droplets that solidify into microparticles for time-release drug delivery. The low-cost nozzle design enables precise particle production at scale, potentially offering suppliers a new manufacturing approach for controlled-release formulations.
- 135MarketSource · Medical Device Network
Tissium wins €60m to bring sutureless nerve repair system to market
Tissium secured €60 million in financing to commercialize COAPTIUM CONNECT, a sutureless peripheral nerve repair surgical system, in the US market. The device represents a new approach to nerve repair that avoids traditional suturing techniques.
- 136New productsSource · Medical Device Network
CereVasc concludes patient enrolment in STRIDE trial of eShunt
CereVasc has completed patient enrollment in the STRIDE clinical trial evaluating its eShunt system for normal pressure hydrocephalus (NPH). The study assesses safety and efficacy of the device ahead of regulatory submissions.
- 137MarketSource · MedCity News
Cadence Rakes In $100M to Automate Chronic Care at Scale
Cadence, an AI-powered chronic care platform, raised $100 million in Series C funding at a $1.23 billion valuation. The company's software monitors patients at home and adjusts medications in real time for heart failure, hypertension, and diabetes management through partnerships with health systems.
- 138MarketSource · MedCity News
Startup Raises $7M for Virtual-First Pediatric Therapy Model
Ladder Health closed a $7 million seed round led by Nina Capital to develop a virtual-first pediatric therapy platform. The funding round included participation from nine additional investors including Mairs & Power Venture Capital, Hatteras Venture Partners, and Create Health Ventures. The company is positioning itself in the digital health space for pediatric rehabilitation and therapy services.
- 139MarketSource · Medical Design & Outsourcing
VitalPath expands catheter manufacturing facility
VitalPath expanded its catheter manufacturing facility in Maplewood, Minnesota into a collaboration hub consolidating executive leadership, new product development, new product introduction, sustaining engineering, and manufacturing operations under one roof. The company said the consolidated approach aims to improve coordination across product development and manufacturing teams.
- 140RegulationSource · Medical Device Network
PorTal Access secures FDA clearance for vascular access ports
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.
- 141RegulationSource · Medical Device Network
Masimo secures FDA approval for OIRD detection on wearable patient monitor
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.
- 142New productsSource · Medical Device Network
Labcorp announces colorectal cancer test availability in US
Labcorp announced US availability of ColoSense, an FDA-approved RNA-based at-home screening test for colorectal cancer. The test expands Labcorp's diagnostic offering in the colorectal cancer screening market, bringing an alternative to existing screening modalities.
- 143TechnologySource · MedCity News
Preparing Healthcare Networks For The Vulnerability Flood
Healthcare networks face escalating cybersecurity threats from zero-day exploits and unpatched backdoors, requiring unified network infrastructure and improved vulnerability forecasting. Medical IT teams must adopt integrated defensive strategies to manage the expanding attack surface in hospital and clinic environments.
- 144MarketSource · Medical Device Network
ZEISS and Envision Health strike VR partnership to advance glaucoma care
ZEISS and Envision Health have formed a partnership to develop virtual-reality applications for glaucoma care. The collaboration combines ZEISS's optical and imaging expertise with Envision Health's digital-health platform to create tools aimed at improving diagnosis, monitoring, and patient management in glaucoma treatment.
- 145RegulationSource · Medical Device Network
Abiomed’s Impella heart pump introducer kits linked to leakage issue in FDA alert
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.
- 146MarketSource · Medical Device Network
Zeal Specialty to support Chemo Mouthpiece device access in US
Chemomouthpiece has partnered with Zeal Specialty Pharmacy to expand US distribution of its Chemo Mouthpiece, an oral cooling device designed to reduce chemotherapy-induced oral mucositis. The partnership leverages Zeal's specialty pharmacy network to improve patient access to the device.
- 147New productsSource · Medical Design & Outsourcing
What Butterfly’s saying about Midjourney’s ultrasonic CT plans
Midjourney, a generative AI company, announced plans to launch its first AI-powered medical imaging facility in 2027 offering whole-body ultrasonic CT scans. The system uses sound and water to complete imaging in 60 seconds without radiation or magnetic fields, positioning it as an alternative to traditional CT and MRI modalities. The facility will operate as a medical imaging spa model.
- 148New productsSource · Medical Design & Outsourcing
Device developers win Junkosha Innovator of the Year Award prizes
Junkosha announced winners of its Technology Innovator of the Year Award. Anchor Balloon Inc. founder Dr. Vishal Gupta received the $25,000 late-phase award for the AngioLock coronary balloon catheter, a device designed to stabilize and simplify stent delivery in complex coronary anatomy. The award recognizes medical device developers working with Junkosha on innovative technologies.
- 149RegulationSource · Medical Device Network
Novocure’s Optune Gio fails to show benefit at earlier stage
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.
- 150RegulationSource · Medical Device Network
FiberSense plans CGM’s commercial readiness following CE mark
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.
- 151MarketSource · Medical Device Network
Sonire Therapeutics awarded $13m from Japanese government-backed innovation agency
Sonire Therapeutics received a $13 million award from a Japanese government-backed innovation agency. The funding supports the company's development efforts, signaling continued investment in the vendor's technology platform and market expansion in Japan.
- 152New productsSource · Medical Device Network
BCAL Diagnostics develops blood test to evaluate breast cancer
BCAL Diagnostics is developing BREASTEST Monitor, a blood test designed to help evaluate women for local breast cancer recurrence following treatment. The test aims to provide a non-invasive monitoring option for post-treatment breast cancer patients.
- 153RegulationSource · Medical Device Network
AngioDynamics secures FDA approval for RELIEF study of NanoKnife
AngioDynamics received FDA approval for an Investigational Device Exemption (IDE) to initiate the RELIEF clinical trial of its NanoKnife system. NanoKnife is an irreversible electroporation (IRE) platform used in surgical ablation procedures. The IDE clearance permits the company to begin enrolling patients in the controlled trial, a key milestone in the development pathway for the device.
- 154MarketSource · Medical Design & Outsourcing
Cretex Medical expands with Holland Molds deal
Cretex Medical, a subsidiary of Cretex Cos., acquired select assets and capabilities from Holland Molds Inc. in Wadena, Minnesota, with the deal closing June 10. The purchase expands Cretex Medical's contract manufacturing and engineering service offerings through its Brooklyn Park-based Component & Device Technologies division.
- 155MarketSource · Medical Device Network
Italy’s WISE raises $34.8m in Series D to advance spinal cord stimulator development
WISE, an Italian medical device company, raised $34.8 million in Series D funding to advance development of its spinal cord stimulator (SCS) system. The device delivers targeted, directional stimulation via minimally invasive percutaneous implantation. The funding will support continued product development and commercialization efforts.
- 156TechnologySource · MedCity News
Combined GI Procedures Are Becoming Routine – AI Can Help Address the Gap in Upper GI Quality Standards
Combined upper and lower GI endoscopy is becoming standard practice in US healthcare settings, but quality-assurance infrastructure for upper GI procedures has not kept pace. AI-driven solutions are emerging to help standardize and monitor upper GI procedure quality across providers.
- 157MarketSource · Medical Device Network
Memphasys and Monash IVF sign national supply deal for Felix system
Memphasys and Monash IVF Group have signed a 12-month exclusive national supply agreement for the Felix automated sperm selection system. The deal grants Monash IVF exclusive rights to distribute the device across Australia.
- 158New productsSource · Medical Device Network
LivaNova’s programming algorithm boosts response rates in sleep apnoea patients
LivaNova announced a proprietary PolySync algorithm that reconfigures proximal hypoglossal nerve stimulation (p-HGNS) fields to improve response rates in sleep apnea patients. The algorithm represents a software enhancement to the company's existing hypoglossal nerve stimulation therapy platform.
- 159RegulationSource · Medical Device Network
Distalmotion secures second FDA gynaecology clearance for DEXTER system
Distalmotion, a Swiss medical device manufacturer, obtained FDA 510(k) clearance for its DEXTER Robotic Surgery System for gynecological procedures including sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and endometriosis resection. This marks the company's second FDA clearance for gynecological applications of the robotic platform.
- 160RegulationSource · Medical Design & Outsourcing
FDA device shortage update includes bloodlines, biopsy needles and more
The FDA updated its device shortage and discontinuance lists, resolving a shortage of dialysis bloodlines while extending expected shortage durations for stereotactic breast biopsy needles, endoscopic vessel harvesting systems, and oxygenator devices for extracorporeal circulation. The extended shortages affect suppliers and hospitals dependent on these critical equipment categories.