- 161TechnologySource · Medical Design & Outsourcing
Researchers complete first-of-its-kind vagus nerve anatomical map
Researchers at Northwell Health's Feinstein Institutes have completed a comprehensive anatomical map of the human vagus nerve, detailed enough to guide development of next-generation neuromodulation and bioelectronic medicine devices. The dataset provides the most detailed reconstruction of vagus nerve anatomy to date, intended to support innovation in device design and therapeutic applications targeting nerve stimulation.
- 162TechnologySource · Medical Design & Outsourcing
Electroninks and SIIX expand additive EMI shielding work
Electroninks and SIIX announced an expanded collaboration to advance additive EMI shielding capabilities. SIIX's new spray coating environment will support prototype trials for a range of products, with the partners working with customers to establish coating processes. The work focuses on metal complex inks for additive manufacturing applied to electromagnetic interference shielding in medical device production.
- 163TechnologySource · MedCity News
How AI Inside Clinical Workflows Is Unlocking Patient Throughput
A MedCity News analysis examines how AI integrated directly into clinical workflows improves patient throughput by delivering relevant information at the point of care decision-making, rather than as standalone reporting tools. The piece emphasizes that workflow integration—not raw AI capability—determines clinical and operational value for healthcare facilities.
- 164RegulationSource · Medical Device Network
Roche’s vaginal infection test obtains FDA clearance
Roche obtained FDA clearance for its cobas assay, a diagnostic test designed to identify bacterial vaginosis and candida vaginitis. The test expands Roche's molecular diagnostics portfolio for gynecological infections.
- 165New productsSource · Medical Design & Outsourcing
Dopl is developing robotics for remote ultrasounds (and one day, much more)
Dopl Technologies, a Bothell, Washington startup, is developing a robotic ultrasound platform that enables remote sonographers to perform patient imaging. The company, co-founded by Ryan James, a former Nvidia medical AI engineer, plans to expand into minimally invasive applications. The platform addresses the challenge of ultrasound access in underserved areas by allowing clinicians to operate imaging equipment remotely.
- 166MarketSource · Medical Device Network
Nuwellis’ new CEO on building a strong foundation for sustainable value creation
Mike McCormick assumed the role of CEO at Nuwellis on 30 June, tasked with building on the company's positive Q1 2026 financial results. Nuwellis manufactures renal replacement therapy and fluid management devices for critical care settings. The leadership transition marks a shift in company strategy as McCormick focuses on sustainable value creation and operational foundation-building.
- 167MarketSource · Medical Device Network
Magnendo raises $18m to advance robotic platform
Magnendo closed an $18 million Series A funding round to advance its magnetic robotic navigation platform for neuro-endovascular procedures. The capital will support further development of the technology, which targets minimally invasive vascular interventions in neurology.
- 168MarketSource · Medical Device Network
Medtronic continues assembly of industry’s “broadest” pain therapy portfolio
Medtronic completed its $650 million acquisition of SPR Therapeutics and formally launched ViaVerte at the American Society of Pain Neuromodulation conference on 16 July. The deal expands Medtronic's pain management portfolio, adding peripheral nerve stimulation technology to its existing spinal cord stimulation and neuromodulation offerings.
- 169TechnologySource · Medical Design & Outsourcing
ITEN advances solid-state batteries for Class III implants
ITEN announced development of solid-state battery technology designed for Class III implantable medical devices. The batteries address energy density, safety, fast-charging, reliability, and miniaturization requirements specific to high-risk implants. The advancement targets next-generation implantable device designs requiring higher capacity and performance within size constraints.
- 170MarketSource · Medical Device Network
Edwards lifts FY26 growth outlook following steady Q2 performance
Edwards Lifesciences raised its full-year 2026 revenue growth guidance following solid second-quarter results, driven primarily by its transcatheter aortic valve replacement (TAVR) business, which generated $1.26 billion in Q2 revenues. The company's strong TAVR performance underpinned confidence in its revised outlook.
- 171RegulationSource · Medical Device Network
FDA grants 510(k) clearance to Velmeni for V4D 3D software
Velmeni received FDA 510(k) clearance for V4D, a 3D software platform designed for dental practitioners. The clearance enables the company to market the software in the US for dental applications.
- 172RegulationSource · Medical Device Network
Science Corporation begins European rollout of Prima system
Science Corporation received CE mark approval from DEKRA for its Prima brain-computer interface device under EU Medical Device Regulation and has begun commercial rollout in Europe. The approval clears the pathway for market distribution across EU member states.
- 173MarketSource · Medical Device Network
bioAffinity and Pictor partner on diagnostics for asthma and COPD
bioAffinity Technologies partnered with Pictor to develop and commercialize diagnostic tests for asthma and chronic obstructive pulmonary disease (COPD). The collaboration combines the companies' capabilities to advance respiratory disease diagnostics, though specific product timelines and technical details were not disclosed.
- 174TechnologySource · Medical Device Network
New AHA report highlights Ultromics’ AI tool’s benefit in earlier heart failure diagnosis
The American Heart Association's Impact Report, generated through its AI Assessment Lab using independent clinical and imaging data, highlights benefits of Ultromics' AI tool for earlier heart failure diagnosis. The tool leverages AI to improve diagnostic timing and accuracy in cardiac assessment.
- 175New productsSource · Medical Design & Outsourcing
First Look: J&J unveils its Ottava surgical robotics system
Johnson & Johnson MedTech received FDA de novo authorization for its Ottava surgical robotics system, a table-integrated soft-tissue surgery platform designed to occupy 30–50% less operating room space than traditional boom-and-cart surgical robot configurations. The system represents the first table-mounted soft-tissue robotic surgery device cleared by the FDA.
- 176RegulationSource · Medical Device Network
J&J MedTech jumps into surgical robot game as OTTAVA secures FDA nod
Johnson & Johnson's MedTech division secured FDA de novo clearance for Ottava, its surgical robotics platform. The company plans an initial launch with select customers, marking J&J's entry into the competitive surgical robotics market.
- 177MarketSource · Medical Design & Outsourcing
Arterex Tecate opens ISO Class 8 clean room facility
Arterex Tecate, a medical device contract manufacturer, opened a 9,000-square-foot ISO Class 8 clean room facility. The expansion increases manufacturing capacity for medical devices and demonstrates the company's investment in quality and regulatory compliance infrastructure.
- 178TechnologySource · Medical Device Network
Navigating the engineering constraints involved in integrating sensors into remote patient monitoring devices – new report reveals
A report addresses engineering challenges in integrating sensors into remote patient monitoring devices, covering sensor integration, signal integrity, feedthrough reliability, and materials durability. The analysis targets suppliers and engineers developing homecare monitoring solutions.
- 179MarketSource · Medical Device Network
TYBR Health lands $30m to advance orthopaedic hydrogel platform
TYBR Health secured $30 million in funding to expand market access for its B3 GEL orthopaedic hydrogel, which launched in the US in January 2026. The company plans to use the capital primarily to grow distribution and market penetration of the platform.
- 180New productsSource · Medical Device Network
Hilo introduces blood pressure monitoring system in US
Hilo, a health technology brand developed by Aktiia, has launched its Hilo Core blood pressure monitoring system in the US market. The system represents a new product entry in the remote patient monitoring and vital signs space.
- 181MarketSource · Medical Design & Outsourcing
Nelipak reports progress on healthcare packaging sustainability
Nelipak Corporation, a healthcare packaging solutions provider, released its 2025 Sustainability Report detailing progress toward long-term sustainability goals and product innovations. The report aligns with the company's stated vision to support sustainable healthcare practices through packaging solutions.
- 182RegulationSource · Medical Device Network
Philips secures FDA clearance for SpO₂ clip sensor
Philips received 510(k) FDA clearance for a next-generation reusable SpO₂ (blood oxygen saturation) clip sensor. The device enables non-invasive patient monitoring and represents a product iteration within Philips's portfolio of patient monitoring solutions.
- 183TechnologySource · Medical Design & Outsourcing
AI is moving inside the device. Who owns the clinical risk?
As AI capabilities integrate deeper into Class II and III medical devices, manufacturers face mounting questions about clinical risk ownership and accountability. The article examines how design and development decisions made years before deployment can create downstream trust and safety issues, and offers guidance for medtech teams to establish clear responsibility frameworks for AI-driven device outputs.
- 184MarketSource · Medical Device Network
Cardinal Health makes acquisition duo worth $360m for home care business advance
Cardinal Health acquired Strive Medical and Adapt Health's diabetes unit in two deals totaling $360 million to expand its home care business. The acquisitions strengthen Cardinal Health's portfolio in at-home medical device and diabetes management services, supporting its stated growth strategy in the home care sector.
- 185TechnologySource · Medical Design & Outsourcing
How to Secure a Medical Device You Can’t Patch
Medical devices cleared for clinical use often remain in service for 15+ years while their embedded software ages without patches, creating security vulnerabilities. The article discusses challenges of securing long-lifecycle devices as new threats emerge, open-source components become outdated, and attack techniques evolve, with commentary on emerging AI tools for device protection.
- 186MarketSource · Medical Device Network
Tempus AI acquires Personalis in $1.5bn precision oncology-focused deal
Tempus AI acquired Personalis for $1.5 billion in an all-stock deal focused on precision oncology. Personalis' minimal residual disease (MRD) testing platform will be integrated into Tempus' oncology portfolio, expanding the combined company's diagnostic and data capabilities in cancer care.
- 187New productsSource · Medical Device Network
Fresenius unveils cloud-based analytics platform for KRT
Fresenius Medical Care launched TherapyWise, a cloud-based analytics platform designed to support hospital and critical care teams managing kidney replacement therapy (KRT) in the US. The platform enables real-time data analysis and clinical decision support for dialysis and renal care providers.
- 188New productsSource · Medical Device Network
ARUP introduces spectral flow assay for multiple myeloma
ARUP Laboratories launched CLARISPECT Multiple Myeloma MRD, a spectral flow cytometry assay for detecting minimal residual disease in multiple myeloma patients. The assay represents a clinical offering from ARUP's diagnostic laboratory services and is designed to support treatment monitoring and patient stratification in hematologic malignancy care.
- 189New productsSource · Medical Design & Outsourcing
Inside the first-of-its-kind Enable Injections enFuse drug delivery wearable
Enable Injections' enFuse on-body injector (OBI) platform achieved its second FDA approval in July 2026 when Sanofi received clearance for an anticancer treatment using the device. The enFuse system previously secured its first combination product approval in 2023 for paroxysmal nocturnal hemoglobinuria. The platform represents a first-of-its-kind wearable drug delivery technology in the oncology space.
- 190TechnologySource · MedCity News
The Same AI That Helps Patients Is Being Used to Attack Them, Hospital Exec Says
Hospital IT security leaders are grappling with dual-use AI risks as healthcare systems deploy machine learning for clinical care while adversaries exploit the same technologies for cyberattacks. Karen Habercoss, CISO at University of Chicago Medicine, discussed governance frameworks needed to manage AI-driven security threats targeting health systems and patient data.
- 191MarketSource · MedCity News
Expecting Massive Test Growth in Cancer & More, Tempus AI Strikes $1.5B Deal to Buy Personalis
Tempus AI announced a $1.5 billion acquisition of Personalis, a liquid biopsy company specializing in minimal residual disease (MRD) assays that detect remaining cancer cells after treatment. Tempus has served as the commercial partner for Personalis's MRD test since 2023. The deal consolidates two players in the growing cancer diagnostics market.
- 192MarketSource · Medical Design & Outsourcing
Medline to open new distribution facility in California
Medline announced plans to open a 1-million-square-foot distribution facility in Perris, California, expanding its logistics network following a similar buildout in Texas. The facility is intended to increase capacity and operational flexibility for healthcare providers across the state.
- 193New productsSource · Medical Device Network
GE HealthCare launches remote MIM workflow access tool
GE HealthCare launched a remote workflow access tool for MIM (medical imaging management) systems designed to enable imaging workflow collaboration among specialist teams, particularly in oncology. The tool is intended to streamline coordination between different departments working with imaging data.
- 194TechnologySource · MedCity News
The AI Tension in Healthcare: Patent Strategy, FDA Reality, and HIPAA Constraints
A MedCity News analysis examines how patent strategy, FDA regulation, and HIPAA privacy requirements create competing pressures for healthcare AI developers. The piece argues that vendors who align these three legal frameworks from inception—rather than addressing them sequentially—will gain competitive advantage in bringing AI-enabled medical devices and software to market.
- 195New productsSource · Medical Device Network
BRIJ Medical unveils wound sealant for surgical incisions
BRIJ Medical has commercially launched BRIJ-SEAL, a wound sealant designed to seal and protect surgical incisions following surgery. The product addresses post-operative wound management in the operating room and recovery settings.
- 196MarketSource · Medical Device Network
British Business Bank commits €25m to EQT Life Sciences’ latest fund
The British Business Bank has committed €25 million to EQT Life Sciences' latest fund. The Bank has prior co-investment experience with EQT portfolio companies Phagenesis and Cyted Health, signaling continued backing of the venture capital firm's life-sciences investments.
- 197New productsSource · Medical Design & Outsourcing
How VahatiCor’s A-Flux nitinol implant is designed to treat coronary microvascular dysfunction (CMD)
VahatiCor has developed the A-Flux, an investigational nitinol implant designed to treat coronary microvascular dysfunction (CMD), a condition in which coronary arteries fail to dilate properly, restricting blood flow to the heart and causing chest pain, shortness of breath, and fatigue without major arterial blockages. The implant addresses a patient population currently lacking targeted interventional options.
- 198TechnologySource · Medical Design & Outsourcing
PTC introduces Onshape Labs for AI-driven product development
PTC announced Onshape Labs, an early-access program integrating AI into its cloud-based product development platform. The initiative enables engineering teams to evaluate emerging AI capabilities within design workflows, using real-time product data to automate tasks and improve design decisions. Broader availability is planned for summer 2024 via opt-in access.
- 199New productsSource · Medical Design & Outsourcing
HiArc to showcase Ctrl platform at ADLM 2026
HiArc will exhibit its Ctrl platform at ADLM 2026 in Anaheim in July. Ctrl is an integrated hardware and software platform designed to accelerate development of medical devices and diagnostic systems. The company will showcase the offering at booth 3555.
- 200RegulationSource · Medical Design & Outsourcing
Noninvasive sepsis SaMD developed at Johns Hopkins offers early warnings
Bayesian Health commercialized a noninvasive sepsis monitoring software as a medical device (SaMD) developed at Johns Hopkins University and received FDA clearance. The AI/ML-based system is the first continuous sepsis monitoring platform of its kind to earn clearance and reportedly detects sepsis hours earlier than conventional clinical assessment.