- 321MarketSource · 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.
- 322New 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.
- 323RegulationSource · 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.
- 324MarketSource · 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.
- 325MarketSource · 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.
- 326TechnologySource · 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.
- 327MarketSource · 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.
- 328New 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.
- 329RegulationSource · 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.
- 330RegulationSource · 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.
- 331TechnologySource · MedCity News
What’s Flowing Beneath the World Cup: How Verily’s Wastewater Monitoring Could Catch the Next Outbreak
Verily is conducting wastewater pathogen monitoring across World Cup host cities, testing for RSV, measles, norovirus, and other pathogens to detect disease outbreaks five to seven days before clinical presentation. The initiative demonstrates application of environmental surveillance technology for early outbreak detection at large-scale public events.
- 332New productsSource · Medical Design & Outsourcing
Why Remedy Robotics thinks it can win the stroke telesurgery race
Remedy Robotics is positioning its N1 System as a competitive offering in the emerging stroke telesurgery market, joining established OEMs and other startups pursuing robotic remote surgical intervention for acute stroke treatment. The company claims early momentum in a segment seen as a major growth opportunity for medical device vendors.
- 333RegulationSource · Medical Device Network
Penumbra’s Thunderbolt approval poised to accelerate neuro thrombectomy innovation
Penumbra received FDA approval for its Thunderbolt system, the first device to offer CAVT (catheter-assisted vacuum thrombectomy) for stroke intervention. The clearance enables the company to commercialize the neuro thrombectomy device and positions it as the initial market entrant for this intervention modality.
- 334RegulationSource · Medical Device Network
FDA clears SurGenTec’s facet fixation system for degenerative disc disease treatment
The FDA cleared SurGenTec's ION-L facet fixation system for treating degenerative disc disease. The clearance was based on data from an IRB-approved study and positions the device as a less invasive alternative for spinal fixation procedures.
- 335New productsSource · Medical Device Network
Raydiant concludes enrolment in pilot study at LSUHS
Raydiant Oximetry has completed enrolment and data collection for a 15-patient pilot study at Louisiana State University Health Sciences Center. The study evaluates the company's oximetry technology in a clinical setting.
- 336RegulationSource · Medical Device Network
FDA approves Bayer’s Ambelvist contrast agent
The FDA has approved Bayer's Ambelvist, a macrocyclic gadolinium-based contrast agent (mGBCA), for MRI imaging in adults and children, including term neonates. The approval expands the available contrast options for magnetic resonance imaging across pediatric and adult populations.
- 337MarketSource · Medical Device Network
J&J outlays $1bn to strengthen Floridian contact lens manufacturing provision
Johnson & Johnson is investing $1 billion to strengthen its contact lens manufacturing capacity in Florida, specifically for its ACUVUE product line. The capital expenditure aims to enhance supply chain resilience and production capabilities for the contact lens portfolio.
- 338TechnologySource · MedCity News
Where Healthcare Data Systems Fail and How to Build Them Better
An analysis of healthcare data system failures and design approaches to improve interoperability and data tracking across multiple platforms. The piece examines common pitfalls in healthcare IT infrastructure and recommends intentional system architecture strategies to enable better data flow and governance in multi-system environments.
- 339RegulationSource · Medical Device Network
FDA clears Dexcom’s Stelo as first OTC glucose monitor for children
The FDA cleared Dexcom's Stelo continuous glucose monitor (CGM) for over-the-counter use in pediatric patients, making it the first OTC CGM approved for children. The clearance expands the product's indication from adults to include pediatric users with diabetes, enabling direct consumer access without prescription.
- 340RegulationSource · Medical Device Network
FDA oncology roundup: drugs, imaging agents and diagnostics gain approval
The FDA has granted clearances to multiple oncology products including drugs, imaging agents, and diagnostics. The approvals span therapeutics and companion diagnostics, affecting suppliers across imaging, laboratory diagnostics, and related oncology device categories.
- 341New productsSource · Medical Device Network
Dimora Medical introduces MegaSorb technology for advanced wound care
Dimora Medical launched MegaSorb technology for silicone foam dressings, a new wound-care consumable product designed to improve absorption in advanced wound management applications.
- 342New productsSource · Medical Design & Outsourcing
Zeus launches XpanCore mandrels for hypotube assembly
Zeus announced XpanCore, a heat-activated mandrel technology designed to simplify hypotube assembly in catheter manufacturing. The mandrels address liner sizing, placement, and adhesion challenges in advanced catheter production, expanding Zeus's polymer solutions portfolio for medical device manufacturers.
- 343TechnologySource · MedCity News
In the Age of AI, Interoperability Isn’t Enough: Why Healthcare Needs Shared Understanding, Not Just Shared Data
A healthcare industry analysis argues that data interoperability alone is insufficient for AI adoption in medical systems. The piece contends that vendors and health systems need frameworks to translate clinical context into consistent, machine-readable representations across platforms and applications to enable safe, effective AI deployment.
- 344RegulationSource · Medical Device Network
FDA clears Penumbra’s Thunderbolt thrombectomy platform for stroke
The FDA has cleared Penumbra's Thunderbolt thrombectomy platform, a computer-assisted vacuum aspiration system designed for clot removal during acute ischemic stroke treatment. The clearance enables commercial distribution of the device for this indication.
- 345RegulationSource · Medical Device Network
Wave Neuroscience wins FDA clearance for precision PTSD therapy
Wave Neuroscience received FDA clearance for its MeRT platform, which uses transcranial magnetic stimulation (TMS) tailored to individual patient brain data for PTSD treatment. The system records patient-specific neural activity to customize stimulation parameters, enabling personalized therapy delivery.
- 346New productsSource · Medical Design & Outsourcing
Assembled Product Specialists expands cleanroom gowning solutions
Assembled Product Specialists announced an expansion of its cleanroom gowning solutions portfolio, offering comprehensive products designed to improve contamination control, organization, and compliance in laboratory and manufacturing cleanroom environments.
- 347New productsSource · Medical Device Network
First patient treated in Airiver Medical’s RESTORE-2 trial for CRS
Airiver Medical has enrolled the first patient in its RESTORE-2 pivotal trial of the ESSpand Sinus drug-coated balloon (DCB) for chronic rhinosinusitis treatment. The trial will evaluate the device's safety and efficacy in expanding and treating inflamed sinus passages. ESSpand represents a minimally invasive alternative to traditional sinus surgery.
- 348MarketSource · Medical Design & Outsourcing
MGS expands hybrid tooling for faster healthcare development
MGS, a healthcare contract development and manufacturing organization, expanded its hybrid tooling capabilities globally. The offering enables pharmaceutical, diagnostics, and medical device companies to validate product designs under production-like conditions before committing to full-scale manufacturing tooling, aimed at accelerating development timelines and reducing time-to-market.
- 349TechnologySource · MedCity News
Abridge Goes Beyond Documentation: 4 Updates
Clinical AI startup Abridge announced a partnership with Nvidia on foundation models, secured investment from Eli Lilly, and expanded its platform capabilities beyond clinical documentation. The company also signaled plans to address payer-provider workflows. The announcements reflect a shift toward broader clinical decision support and operational integration rather than standalone transcription.
- 350RegulationSource · Medical Design & Outsourcing
A boy’s death is a tragic example of foreseeable risk in device design
A medical device recall involving a hospital bed has resulted in a child fatality, highlighting design flaws that were foreseeable during development. The incident underscores the importance of hazard analysis and risk mitigation in device design for medtech engineers and manufacturers to prevent similar failures in equipment safety and compliance.
- 351TechnologySource · MedCity News
From Copilots to Clinical Judgment: The Next Phase of AI in Digital Behavioral Health
MedCity News discusses the evolution of AI in digital behavioral health platforms beyond basic copilot assistance toward integrated decision-support systems where clinicians, supervisors, and AI collaborate. The shift focuses on building systems that enable human-AI interaction to improve clinical decision-making rather than replacing clinician judgment.
- 352MarketSource · Medical Device Network
How Shockwave Medical plans to keep rivals at bay in burgeoning IVL sector
Shockwave Medical is strengthening its competitive position in the intravascular lithotripsy (IVL) market as rivals explore entry into the sector. The company is pursuing a strategy centered on continued innovation and clinical data generation to defend its market share against emerging competition.
- 353RegulationSource · Medical Device Network
Subtle Medical lands FDA clearance for AI CT imaging software
Subtle Medical received FDA clearance for SubtleHD(CT), an AI software tool designed to enhance CT image quality. The clearance expands the company's portfolio of AI imaging products, which already includes SubtlePET for PET imaging and SubtleHD(MR) for MR imaging enhancement.
- 354RegulationSource · Medical Device Network
FDA clears KARL STORZ’s RUBINA Lens for use in open surgery
KARL STORZ received FDA clearance for its RUBINA Lens exoscope for use in open surgical procedures. The exoscope is a visualization tool that provides magnified, high-definition imaging during open surgery, enabling surgeons to view the operative field with enhanced detail and precision.
- 355MarketSource · Medical Device Network
Podcast: How Shockwave Medical plans to keep rivals at bay in burgeoning IVL sector
Shockwave Medical, the pioneer in intravascular lithotripsy (IVL), is discussing competitive strategy as the sector gains traction and new entrants approach. IVL uses acoustic pulse technology to treat calcified vascular lesions, and Shockwave's early-mover advantage has driven strong adoption. The podcast explores how the company plans to maintain market position amid emerging competition in this growing interventional cardiology segment.
- 356RegulationSource · Medical Device Network
Sibel Health’s ANNE One platform secures EU MDR CE mark
Sibel Health has obtained CE mark certification under the EU Medical Device Regulation for its ANNE One system, which has been classified as a Class IIb medical device. The certification enables the platform to be marketed across the EU.
- 357TechnologySource · Medical Design & Outsourcing
Beyond real-time vitals: Enabling long-term biomarker measurement in wearable optical sensing
ams OSRAM discusses advances in optical sensing technology for wearable devices that extend beyond real-time vital signs to enable long-term biomarker measurement. The article explores how modern wearables capture physiological data including heart rate and blood oxygen, with implications for broader health monitoring applications.
- 358MarketSource · Medical Design & Outsourcing
Gerresheimer expands Georgia plant and makes automation upgrades
Gerresheimer, a German medical device CDMO, has expanded its Peachtree City, Georgia manufacturing facility and installed two automated storage and retrieval systems (AS/RS) to boost production and logistics capacity. The plant manufactures inhalers, infusion components, microinjectors, microbiological test cards, and autoinjectors.
- 359New productsSource · Medical Design & Outsourcing
Medical robotics and AI advice from a J&J DePuy Synthes leader
Johnson & Johnson's DePuy Synthes has launched Velys Hip Navigation with AI Assistance software. A company leader emphasized that AI development should address specific clinical problems rather than pursue the technology for its own sake, advising vendors to consult surgeons on meaningful improvements to patient care workflows.
- 360RegulationSource · Medical Device Network
FDA grants IDE to SpinaFX for study of Triojection
SpinaFX Medical received FDA investigational device exemption (IDE) approval to conduct clinical studies of its Triojection therapy, a spinal intervention device. The IDE clearance permits human investigation of the device as part of the regulatory pathway toward potential market authorization.