- 121RegulationSource · Medical Device Network
Natera seeks Japan’s PMDA approval for Signatera test in MIBC
Natera submitted a regulatory application to Japan's PMDA (Pharmaceuticals and Medical Devices Agency) for approval of its Signatera test as a companion diagnostic for muscle-invasive bladder cancer (MIBC). The test is designed to detect circulating tumor DNA and inform treatment decisions in this patient population.
- 122MarketSource · Medical Device Network
Azra AI and Blackford partner to connect imaging AI with care coordination
Azra AI and Blackford announced a partnership to integrate imaging-based AI detection with care coordination workflows for patients with complex or urgent conditions. The partnership aims to bridge diagnostic imaging AI output with downstream clinical care management systems, enabling better handoff and coordination between detection and treatment planning.
- 123MarketSource · Medical Device Network
Zimmer Biomet reports 4.8% YoY revenue uptick in Q2; raises 2026 outlook
Zimmer Biomet reported 4.8% year-over-year revenue growth in Q2 and raised its 2026 financial outlook, driving a 5% share price increase at NYSE opening on August 5. The earnings beat reflects demand across the company's orthopedics, spine, and specialty surgical portfolios.
- 124TechnologySource · Medical Device Network
Podcast: RevealDx’s CEO on the global radiologist shortage
RevealDx's CEO discusses the global radiologist shortage in a podcast interview. The UK NHS spent £241 million on outsourced radiology reads in 2025, a 12% increase from 2024, underscoring rising demand for diagnostic imaging services and potential market opportunity for AI-assisted radiology platforms and workflow solutions.
- 125MarketSource · Medical Device Network
Wellinks secures $10m for respiratory disease RPM tool’s advancement
Wellinks raised $10 million in Series B funding to advance its remote patient monitoring platform for respiratory disease management. The round included participation from UMass Memorial Health, building on an existing relationship. The funding will support continued development of the RPM tool for chronic respiratory conditions.
- 126MarketSource · Medical Device Network
SMT adopts Siemens software for device innovation
SMT has implemented Siemens' Teamcenter software to accelerate medical device innovation and manage product lifecycles across the organization. The deployment reflects a vendor's investment in digital infrastructure to improve R&D efficiency and time-to-market for device development.
- 127MarketSource · Medical Device Network
SOPHiA GENETICS partners with AstraZeneca for oncology diagnostics
SOPHiA GENETICS and AstraZeneca announced a partnership to co-develop and launch two companion diagnostics for precision oncology therapies. The collaboration combines SOPHiA's diagnostic software platform with AstraZeneca's oncology drug portfolio, positioning both firms to expand their presence in the companion diagnostics market.
- 128RegulationSource · Medical Device Network
Galaxy Therapeutics secures CE mark for embolisation system
Galaxy Therapeutics obtained CE mark approval for its saccular endovascular aneurysm lattice (SEAL) embolisation system. The company plans a phased commercial rollout across select European markets following the regulatory clearance.
- 129New productsSource · Medical Device Network
GE HealthCare expands breast imaging portfolio with launch of new product duo
GE HealthCare launched two new breast imaging products designed to improve lesion detection in women with dense breast tissue and streamline enterprise workflows. The tools expand GE's existing breast imaging portfolio and address a clinical need in screening and diagnostic applications.
- 130MarketSource · Medical Device Network
KKR to acquire Integer Holdings in $5.7bn all-cash deal
KKR has agreed to acquire Integer Holdings in an all-cash transaction valued at $5.7 billion. Integer Holdings is a supplier of medical devices and components to the healthcare industry, making this a significant consolidation in the medical equipment and supplies vendor landscape.
- 131MarketSource · Medical Device Network
Profusa vies for potential G3 Vision Labs acquisition
Profusa is pursuing a potential acquisition of G3 Vision Labs to expand its diagnostic portfolio with routine chemistry, toxicology, and pathology offerings. The deal would add laboratory diagnostic capabilities to Profusa's existing product lines.
- 132RegulationSource · Medical Device Network
FDA grants 510K clearance for DeepHealth’s AI breast ultrasound technology
DeepHealth received FDA 510(k) clearance for DeepHealth Breast Ultrasound, an AI-based tool designed to assist in breast ultrasound imaging analysis. The clearance enables the company to market the software as a medical device in the US.
- 133MarketSource · Medical Device Network
CereVasc expands manufacturing with Wilmington facility for eShunt system
CereVasc opened a manufacturing and research facility in Wilmington, Massachusetts to support potential commercialization of its eShunt System, an investigational device for hydrocephalus management. The expansion signals preparation for market entry as the company advances toward regulatory pathways.
- 134MarketSource · Medical Design & Outsourcing
Quasar Medical buys Medres Nitinol Design and Development Center
Quasar Medical, a contract development and manufacturing organization specializing in minimally invasive devices, has acquired Medres' Nitinol Design and Development Center near San Diego. The 10,000-square-foot Carlsbad facility, established in 2024 and expanded in 2025, brings dedicated nitinol engineering talent and manufacturing capabilities to Quasar's operations.
- 135New productsSource · Medical Design & Outsourcing
J&J’s robotics R&D head discusses Ottava’s folding arms, soothing sounds and haptics capability
Johnson & Johnson MedTech announced its Ottava surgical robotics system following FDA de novo authorization. The system features folding arms, haptic feedback capability, and is positioned as a category-defining soft-tissue surgical platform. The company unveiled the device at the July 2026 Society of Robotic Surgery annual meeting.
- 136MarketSource · Medical Device Network
Dexcom tweaks full-year outlook after reporting 13% growth in Q2
Dexcom reported 13% revenue growth in Q2 and adjusted its full-year outlook upward following the earnings release on July 30. The company's Nasdaq shares rose over 8% to $81.04 at market open July 31, reflecting investor confidence in the revised guidance.
- 137MarketSource · Medical Device Network
Stryker nets $6.6bn revenue in Q2; highlights resilience following cyberattack
Stryker reported $6.6 billion in Q2 revenue following a March 2026 cyberattack that disrupted global operations. The earnings result demonstrates the company's operational resilience despite the security incident and its recovery efforts.
- 138RegulationSource · Medical Device Network
FDA clears Total Flow Medical cannula for cardiopulmonary bypass
Total Flow Medical received 510(k) FDA clearance for its femoral arterial cannula designed for cardiopulmonary bypass procedures. The clearance enables the company to market the device for use in cardiac surgery applications requiring extracorporeal circulation support.
- 139MarketSource · MedCity News
Why General Catalyst Is Betting $450M on Function Health’s Preventive Care Push
Function Health, a lab-testing and imaging services startup, raised $450 million in growth financing from General Catalyst's Customer Value Fund, eight months after closing a $298 million Series B round. The company plans to use the capital to expand access to its testing and imaging service offerings.
- 140MarketSource · Medical Device Network
Median Technologies and Olea sign partnership for lung cancer device
Median Technologies partnered with Olea Medical to commercialize eyonis LCS, a lung cancer screening software, across the US and European markets. The collaboration expands distribution capabilities for the AI-enabled diagnostic tool designed to support lung nodule analysis in imaging workflows.
- 141New productsSource · Medical Design & Outsourcing
How BD wants to advance noninvasive continuous patient monitoring
Becton, Dickinson and Co. has developed a platform for noninvasive continuous blood pressure monitoring, advancing its vision of continuous patient monitoring from admission through discharge. Tim Patz, worldwide president of BD's Advanced Patient Monitoring business, leads the effort to extend monitoring capabilities across the patient care continuum.
- 142MarketSource · Medical Device Network
Baxter’s shares soar by 17% after reporting positive Q2
Baxter International reported a 5% profit increase in Q2 compared to the same period last year, when results were depressed by hurricane damage to a North Carolina manufacturing facility. The earnings announcement drove a 17% surge in the company's stock price.
- 143MarketSource · Medical Device Network
CoreMap raises $37m in Medtronic-led financing round
CoreMap, a privately held medical device company founded in 2016, raised $37 million in a financing round led by Medtronic. The funding nearly doubles the company's total capital raised to date. No additional details on CoreMap's product focus or intended use of proceeds were provided.
- 144New productsSource · Medical Device Network
VDyne treats first patient in TRIVITA trial of TriNova system
VDyne has enrolled and treated the first patient in the TRIVITA US IDE pivotal study of its TriNova transcatheter tricuspid valve replacement system. The trial is designed to evaluate safety and efficacy of the device in patients with symptomatic tricuspid regurgitation.
- 145MarketSource · Medical Device Network
Trace secures funding from Axogen for nerve imaging technology
Trace Biosciences received strategic funding from Axogen to develop Nerve Trace, a nerve-specific imaging technology. The investment supports advancement of the imaging platform, which targets nerve visualization applications relevant to surgical and diagnostic workflows.
- 146MarketSource · MedCity News
Doctronic Acquires Summer Health to Expand into Pediatric Primary Care
Doctronic acquired Summer Health to expand its AI-powered primary care platform into pediatric care. The deal strengthens Doctronic's digital health offerings and extends its reach into the pediatric primary care segment.
- 147MarketSource · MedCity News
Epic-First Doesn’t Mean Epic-Only: Where Hospitals Are Still Buying from Startups
A survey of 112 health system executives shows Epic's dominance in hospital IT continues to grow, yet startups retain purchasing opportunities by addressing gaps Epic has not filled, delivering measurable ROI, or solving specific clinical or operational problems. The findings suggest a tiered procurement model where health systems prioritize Epic integration but remain open to best-of-breed vendors that complement rather than replace their core platform.
- 148MarketSource · Medical Device Network
Boston Scientific reports positive Q2 results yet opts to trim 2026 outlook
Boston Scientific reported positive second-quarter financial results but reduced its 2026 outlook, citing planned global restructuring efforts. The company's earnings beat expectations, though the forward guidance cut reflects anticipated impacts from the reorganization program on future performance and operations.
- 149RegulationSource · MedCity News
A New Era of Interoperability, But Who Gets Left Behind?
CMS has introduced a new interoperability framework that requires healthcare vendors to meet baseline standards for network participation, though implementation is phased rather than immediate. The policy raises questions about which vendors may struggle to comply with the technical requirements, potentially affecting market entry and competitive dynamics in health IT systems.
- 150TechnologySource · MedCity News
The Healthcare Cloud Maturity Model: The Five Stages Most Health Systems Skip
A framework outlines five stages of healthcare cloud maturity, addressing a common industry misconception that cloud adoption is binary rather than progressive. Each stage unlocks new capabilities, and health systems often skip intermediate phases, leading to cost overruns and capability gaps. The model provides guidance for IT leaders planning cloud strategy and deployment.
- 151RegulationSource · Medical Device Network
FDA grants 510(k) clearance for Elevation Spine’s Saber-C AVIA device
Elevation Spine received FDA 510(k) clearance for the Saber-C AVIA, a cervical fixation device designed for spinal surgery. The clearance enables the company to market the device in the United States.
- 152RegulationSource · Medical Device Network
CorVista wins FDA clearance for AI heart failure assessment add-on
CorVista received FDA clearance for an AI-based pulmonary capillary wedge pressure assessment add-on for heart failure evaluation. This marks the company's third FDA clearance for its cardiopulmonary platform, expanding its diagnostic software capabilities in cardiac assessment.
- 153MarketSource · MedCity News
Smart Toilet Sensor Startup Is Flush with $10M Funding
Throne Science, a startup developing an AI-powered toilet sensor for monitoring gut health, hydration, and urinary function, closed a $10 million Series A funding round. The company positions the device as an early-warning system for colorectal cancer and other gastrointestinal conditions, addressing a gap in home health monitoring.
- 154New productsSource · Medical Design & Outsourcing
Zeus wins PFAS-free certification for PFX Flex catheter liners
Zeus announced that its PFX Flex Sub-Lite-Wall catheter liners have received Intertek certification as PFAS-free, becoming the first medical device components certified free of per- and polyfluoroalkyl substances. The certification reflects growing regulatory and customer pressure on device makers to eliminate these persistent chemicals from their products.
- 155MarketSource · Medical Device Network
Boston Scientific expects headcount reductions amid restructuring initiative
Boston Scientific announced a restructuring initiative expected to result in headcount reductions, with total costs estimated between $700 million and $800 million through the end of 2029. The company did not disclose the specific number of positions affected or operational details in the announcement.
- 156TechnologySource · MedCity News
Spotting Alzheimer’s Years Earlier Through AI and Clinically Meaningful Insights
Researchers have developed an AI-based diagnostic approach using digital tablet interaction and speech analysis to detect Alzheimer's disease patterns earlier than traditional methods like advanced imaging or prolonged clinical observation. The technology reduces detection time and may identify cases previously undetectable through conventional means.
- 157MarketSource · Medical Device Network
Xeltis sharpens US market roadmap after €20.5m fundraise
Xeltis raised €20.5 million in funding to refine its US market strategy, following a €47.5 million round completed in December 2025. The Swiss biotech company, which develops bioresorbable scaffolds and regenerative medical devices, is using the capital to accelerate commercialization efforts in North America.
- 158RegulationSource · Medical Device Network
Patient enrolment concludes in Glaukos’ Preserflo MicroShunt trial
Glaukos has completed patient enrolment in its US 510(k) pivotal trial for the Preserflo MicroShunt, a drainage device designed to treat primary open-angle glaucoma in adults. The trial conclusion marks a milestone toward potential FDA clearance of the device.
- 159New productsSource · Medical Device Network
Labcorp expands hereditary risk testing access with genetic health panel
Labcorp launched Marker by Labcorp Genetic Health Panel, a consumer-accessible genetic test that screens for hereditary risk across more than 100 medically actionable conditions. The panel expands direct-to-consumer access to hereditary risk assessment, enabling broader screening for genetic predispositions to disease.
- 160New productsSource · Medical Design & Outsourcing
TE Connectivity adds 3D printing for catheter shafts
TE Connectivity introduced an automated 3D printing process for manufacturing catheter shafts supplied to medical device makers, replacing a manual assembly method. The new process is designed to reduce production costs and streamline manufacturing for one of the supplier's key product lines.