- 081RegulationSource · Medical Device Network
FDA greenlights Edwards’ expandable pulmonary valve for paediatric patients
The FDA has approved Edwards Lifesciences' Autus expandable pulmonary valve for paediatric patients, marking the first FDA-cleared heart valve designed to expand post-implantation to accommodate a child's growth. The device addresses a clinical need in paediatric cardiology where traditional fixed valves require multiple replacement surgeries as children grow.
- 082MarketSource · Medical Device Network
Siemens Healthineers partners with Truvian to advance blood test platform
Siemens Healthineers has partnered with Truvian to advance the company's blood test platform. The alliance includes plans to develop and commercialize future diagnostic solutions, expanding both firms' capabilities in in vitro diagnostics.
- 083TechnologySource · Medical Device Network
Podcast: Continuous monitoring’s burgeoning role in metabolic health
Continuous monitoring devices are expanding beyond glucose tracking to measure additional biomarkers relevant to metabolic health, obesity, and diabetes management. The shift reflects growing interest among device makers in non-glucose metabolic indicators to support broader metabolic disease monitoring and prevention strategies.
- 084MarketSource · Medical Device Network
Inogen sharpens business focus with $25m oxygen rental unit divestment
Inogen divested its oxygen rental unit for $25 million, citing declining revenues in that segment. The sale reflects the company's strategic shift to focus on core business lines as the rental business faced headwinds.
- 085New productsSource · Medical Device Network
Roche’s TIB MOLBIOL introduces in vitro newborn screening test kit
Roche Diagnostics subsidiary TIB MOLBIOL launched the LightMix Newborn TREC/SMN1/HBB, an in vitro diagnostic test kit for newborn screening. The test targets three conditions: T-cell receptor excision circles (TREC), spinal muscular atrophy (SMN1), and sickle cell disease (HBB gene).
- 086New productsSource · Medical Device Network
Abbott rolls out SimpleScreen CRC blood test across US
Abbott has commercially launched SimpleScreen CRC, an FDA-approved blood test for colorectal cancer screening, across the United States. The test represents a non-invasive screening option in the colorectal cancer detection market.
- 087New productsSource · Medical Device Network
Siemens Healthineers introduces Innovance D-Dimer 2.0 assay
Siemens Healthineers launched Innovance D-Dimer 2.0, a new assay for detecting blood clots, following CE mark certification and FDA 510(k) clearance. The product is now available globally for clinical laboratory use in thrombosis screening and patient management.
- 088RegulationSource · Medical Device Network
FDA clears Cepheid’s multiplex respiratory panel test
The FDA has granted clearance to Cepheid for its Xpert Respiratory Panel, a multiplex PCR diagnostic test designed to detect multiple respiratory pathogens. The clearance enables market distribution of the assay, which runs on Cepheid's GeneXpert platform.
- 089MarketSource · MedCity News
Tiny Health Secures $33M to Expand Microbiome Testing
Tiny Health raised $33M in Series B funding led by B Capital to expand its microbiome testing offerings. The round included participation from nine venture firms including Spero Ventures and The Venture City. Tiny Health provides microbiome analysis services, typically used for pediatric and family health assessment.
- 090TechnologySource · Medical Device Network
Fuse Oncology and AMP launch trial of FuseRx workflow platform
Fuse Oncology and AMP have launched a proof-of-concept trial of FuseRx, a clinical workflow platform designed for oncology settings. The collaboration aims to validate the platform's ability to streamline clinical processes and data management in cancer care environments.
- 091MarketSource · Medical Device Network
Eden Radioisotopes gains support from New Mexico for $1.4bn medical facility
Eden Radioisotopes has secured state support from New Mexico for a $1.4 billion medical isotope manufacturing facility. The backing enables expansion of domestic radioisotope production capacity, a key input for diagnostic imaging and nuclear medicine applications used by hospitals and imaging centers.
- 092RegulationSource · MedCity News
DreaMed Wins FDA Clearance for CGM-Driven Insulin Automation Tool for Both Type 2 Injection Regimens
DreaMed Diabetes obtained FDA 510(k) clearance for MODI, a mobile application that integrates continuous glucose monitoring data to generate insulin dosing recommendations for Type 2 diabetes patients on basal and fast-acting injection regimens. The clearance expands the tool's indication from prior single-injection use cases.
- 093RegulationSource · Medical Device Network
Intuitive re-enters European cardiac surgery market following da Vinci 5 CE mark
Intuitive Surgical has obtained CE mark approval for its da Vinci 5 robotic surgical system for cardiac procedures in Europe, enabling the company to re-enter the European cardiac surgery market. The clearance represents a significant regulatory milestone and positions Intuitive to expand its robotic surgery footprint in the region.
- 094New productsSource · Medical Device Network
Cardiac diagnostics: supporting more sensing in smaller, fatigue-resistant designs
A fatigue-resistant wire material is enabling the development of smaller cardiac catheters with integrated sensing capabilities for electrophysiology procedures. The advancement allows for more reliable real-time data collection during EP interventions while reducing device footprint.
- 095MarketSource · Medical Device Network
Firefly to offer NeuroSigma’s non-drug ADHD device to clinicians
Firefly Neuroscience and NeuroSigma announced a partnership to distribute NeuroSigma's Monarch eTNS System, a non-pharmacological device for pediatric ADHD, to clinicians. The Monarch uses transcranial neurostimulation technology and represents a vendor collaboration to expand market reach for the cleared device.
- 096MarketSource · Medical Device Network
Accuray partners with Samsung NeuroLogica on CyberKnife imaging
Accuray announced a partnership with Samsung NeuroLogica to integrate advanced volumetric imaging capabilities into its CyberKnife robotic radiosurgery platform. The collaboration aims to enhance imaging performance for the radiation therapy system used in oncology and neurosurgery procedures.
- 097TechnologySource · MedCity News
AI Goes All In To Support Nursing Teams: Ambient Charting is Just the Start
Healthcare organizations are deploying AI-powered ambient charting and related tools to reduce nursing documentation burden and free staff time for direct patient care. The article examines whether these solutions will integrate seamlessly into existing workflows or add fragmentation to the technology stack nurses already manage.
- 098RegulationSource · Medical Device Network
FDA clears Marani Health’s remote maternal monitoring system
The FDA cleared Marani Health's M•wrap, a remote maternal monitoring system designed to enable at-home monitoring of fetal and maternal heart signals. The device allows patients to avoid clinic visits for routine monitoring.
- 099New productsSource · Medical Device Network
Revvity introduces GSP T1D 3plex kit for type 1 diabetes detection
Revvity launched the GSP T1D 3plex kit, a diagnostic product designed to screen children for type 1 diabetes risk before symptom onset. The kit supports population screening programs by enabling early detection of autoimmune markers associated with T1D development.
- 100RegulationSource · Medical Device Network
FDA grants breakthrough designation to Glytec’s Glucommander Pediatrics
The FDA granted breakthrough device designation to Glytec's Glucommander Pediatrics, an insulin dosing recommendation algorithm intended for hospitalized newborns and infants under two years old. Breakthrough designation accelerates review pathways for devices addressing unmet clinical needs.
- 101MarketSource · Medical Device Network
Anaconda Biomed raises $56m for catheter portfolio’s advance
Anaconda Biomed secured $56 million in funding to advance its catheter portfolio and support clinical development, including completion of a pivotal IDE study. The capital will accelerate the company's pipeline toward regulatory approval and commercialization.
- 102RegulationSource · Medical Device Network
FDA panel endorses GRAIL’s multi-cancer early detection test
An FDA advisory panel voted 7-2 to endorse GRAIL's Galleri multi-cancer early detection test, finding that its clinical benefits outweigh risks. The panel's recommendation supports the company's pathway toward potential regulatory clearance for this blood-based screening assay designed to detect multiple cancer types in asymptomatic individuals.
- 103New productsSource · Medical Device Network
Xella and ŌURA integrate for women’s health management
Xella Health announced an integration with ŌURA to create a connected precision health platform tailored for women's health management. The partnership combines both companies' capabilities to deliver personalized health monitoring and insights based on women's biological data.
- 104New productsSource · Medical Device Network
Precision Diabetes and DirectSens to introduce MetMark test in US
Precision Diabetes and DirectSens have partnered to commercialize the MetMark clinical test in the US. The test measures AHB and 2-HB biomarkers associated with metabolic dysfunction and type 2 diabetes risk. The collaboration marks the US market entry for this diagnostic offering.
- 105MarketSource · MedCity News
Teal Health Secures $22M for At-Home HPV Cervical Cancer Screening Device
Teal Health raised $22 million in Series A funding for an at-home HPV cervical cancer screening device. The round was led by .406 Ventures with participation from Emerson Collective, Forerunner, Serena Ventures, and MPower Partners. The device addresses a gap in accessible cervical cancer screening by enabling testing outside traditional clinical settings.
- 106RegulationSource · Medical Device Network
NET Recovery wins FDA breakthrough tag for psychostimulant addiction device
NET Recovery received FDA Breakthrough Device designation for a neurostimulation device designed to treat psychostimulant addiction by reducing cravings in patients with stimulant use disorder. The designation expedites the device's regulatory pathway.
- 107MarketSource · Medical Device Network
Teal Health raises $22m for at-home HPV cervical cancer screening test
Teal Health raised $22 million to expand its at-home HPV cervical cancer screening test ahead of anticipated changes to federal insurance guidelines for cervical cancer screening. The funding will support broader distribution of the test.
- 108RegulationSource · Medical Device Network
FDA clears Myrava’s patient-specific bolus device
Myrava received 510(k) clearance from the FDA for its patient-specific, 3D-printed bolus device designed for use in radiation therapy. The device is manufactured using 3D printing technology to customize bolus shapes for individual patients during treatment.
- 109MarketSource · Medical Device Network
QC Healthcare and Sanguina collaborate for AI blood health tools
QC Healthcare partnered with Sanguina to integrate AI-based blood health technologies into its digital healthcare platforms across the US. The collaboration combines Sanguina's blood analysis capabilities with QC Healthcare's platform infrastructure to expand AI-driven diagnostic offerings.
- 110New productsSource · MedCity News
Pelago Unveils New Behavioral Health Platform for Substance Use, Mental Health and Behavioral Addiction Care
Pelago launched a behavioral health platform integrating substance use disorder, mental health, and behavioral addiction care management. The platform uses AI-powered triage to match patients with appropriate treatment resources. The offering targets healthcare providers and systems managing behavioral health populations.
- 111TechnologySource · MedCity News
How is Oracle Health’s Nurse AI Agent Different?
Oracle Health has introduced a Clinical AI Agent designed for nurses, embedded directly within the Oracle Health Foundation EHR platform. The integration eliminates the need for clinicians to switch between separate tools, streamlining workflow within a single system.
- 112MarketSource · Medical Device Network
Dialybrid raises $17m to advance Silkothane device
Dialybrid closed a €15 million Series A funding round to advance development of its Silkothane arteriovenous graft for hemodialysis vascular access. The capital will support the progression of the device intended to improve outcomes in dialysis patients requiring long-term access.
- 113RegulationSource · Medical Device Network
FDA approves Cordis SELUTION SLR for coronary in-stent restenosis
The US FDA has approved Cordis' SELUTION SLR (sustained limus release) drug-eluting balloon for treatment of coronary in-stent restenosis. The approval expands the indication for the device beyond its previous clearance.
- 114TechnologySource · MedCity News
How AI Is Transforming Clinical Documentation at Intermountain Health
Intermountain Health has deployed AI clinical documentation improvement tools that increased inpatient chart completion by 22 percentage points when completed during or immediately after clinical rounds. The implementation demonstrates adoption of AI-driven workflow automation in hospital documentation processes.
- 115RegulationSource · Medical Device Network
Koning Health secures Australian TGA approval for breast CT system
Koning Health has received Australian Therapeutic Goods Administration approval for its Koning Breast CT System. The clearance expands the vendor's regulatory footprint in the Asia-Pacific region for breast imaging applications.
- 116MarketSource · Medical Device Network
CardiaCare secures seed extension funding for AFib clinical studies
CardiaCare closed an oversubscribed seed extension funding round to support clinical pilot studies of its wearable cardiac arrhythmia monitoring technology, including atrial fibrillation detection.
- 117TechnologySource · MedCity News
Two Years After the Change Healthcare Cyberattack, Healthcare Still Has a Clearinghouse Redundancy Problem
Two years after Change Healthcare's cyberattack disrupted healthcare operations nationwide, the industry remains vulnerable due to inadequate redundancy in clearinghouse infrastructure. The incident exposed systemic reliance on a single dominant vendor for claims processing and billing, creating a critical single point of failure across the healthcare supply chain. Despite the attack, healthcare systems have not implemented sufficient backup systems or diversified clearinghouse dependencies, leaving the sector at risk of similar operational disruptions.
- 118MarketSource · MedCity News
Ayble Health Secures $16M for Virtual Digestive Health Clinic
Ayble Health raised $16 million in Series A funding led by Neon to expand its virtual digestive health clinic platform. The round included participation from Unum Ventures, Upfront Ventures, M13, Cleveland Clinic Ventures, DigiTx, and Accomplice. Ayble operates a telehealth service focused on gastrointestinal conditions and management.
- 119MarketSource · Medical Device Network
FIZE Medical secures $20m funding to advance FIZE Optima system
FIZE Medical closed the first tranche of a $20 million Series B funding round to accelerate development of its FIZE Optima platform. The capital will support the next-generation system's advancement, though specific technical details and product applications were not disclosed in the announcement.
- 120RegulationSource · Medical Device Network
FDA clears Neptune Medical’s Triton 1 system for colon procedures
Neptune Medical received FDA clearance for its Triton 1 System, a robotic platform designed to assist with flexible endoscopy procedures throughout the colon. The clearance enables market entry for the robotic-assisted colonoscopy device.