- 041MarketSource · Medical Device Network
Veritas Aortic Solutions raises $12m for aortic disease treatment advance
Veritas Aortic Solutions secured $12 million in funding to advance its technology for treating acute aortic root and ascending aorta pathologies without open heart surgery. The company is developing a minimally invasive approach to address aortic disease, positioning itself as an alternative to conventional surgical intervention.
- 042New productsSource · Medical Device Network
ASCO26: Data highlights test benefit in breast cancer treatment planning and earlier detection
Veracyte presented clinical data on its Prosigna genomic assay for breast cancer treatment planning at ASCO 2026, alongside findings from GRAIL's multi-cancer early detection test. The data highlighted the assays' utility in guiding therapy selection and enabling earlier cancer identification, supporting their role in precision oncology and screening workflows.
- 043RegulationSource · Medical Device Network
SHINE Technologies receives EU CMA for Ilumira Lu-177 radioisotope
SHINE Technologies obtained a Conditional Marketing Authorization (CMA) from European regulators for Ilumira, its Lu-177 radioisotope product. The clearance permits commercial distribution of the radiopharmaceutical across EU member states. Lu-177 is used in targeted radionuclide therapy for neuroendocrine tumors and other cancers.
- 044RegulationSource · Medical Device Network
SKIA secures FDA 510(k) clearance for AR surgical platform
SKIA, a South Korean medical technology company, received FDA 510(k) clearance for SKIA HEAD, an augmented reality surgical guidance system. The clearance enables the company to market the platform in the US for intraoperative visualization and navigation.
- 045TechnologySource · Healthcare IT News
Budget 2026: New Zealand funds digital health upgrades, cybersec
New Zealand's 2026 budget allocates NZ$450 million ($270 million) for digital health infrastructure and cybersecurity across the public health system. Te Whatu Ora Health New Zealand will receive NZ$153.6 million ($91.7 million) to expand 24/7 cybersecurity monitoring and response capabilities, strengthen specialist expertise, and deploy critical security upgrades across primary care and hospital networks.
- 046TechnologySource · Medical Device Network
When SSRIs fail: the neuromodulation pathway
Device-based neuromodulation therapies are emerging as an alternative treatment pathway for patients with depression who do not respond adequately to SSRIs. The article examines how neuromodulation devices can address treatment-resistant depression, positioning them as a viable clinical option for this patient population.
- 047MarketSource · Medical Device Network
Countable Labs raises $26m for PCR technology advancement
Countable Labs closed a $26 million funding round to advance its PCR technology platform, which the company claims delivers at least tenfold sensitivity improvement over conventional PCR. The capital will support product development and commercialization of the diagnostic tool.
- 048MarketSource · Healthcare IT News
Telehealth roundup: Amazon hires Amwell founder, Teladoc expands access and more
Amazon appointed Dr. Roy Schoenberg, founder of Amwell, as senior vice president of its Health Services division. Separately, Walmart integrated Teladoc Health services into its Better Care Services platform to expand customer access to third-party providers. GoodRx launched a new subscription service for generic medications.
- 049TechnologySource · MedCity News
The EHR Was Built to Store Data — It Wasn’t Built to Orchestrate Care
Digital health vendors are advancing beyond traditional EHR data storage by adding AI-powered orchestration layers to enable real-time care activation. The approach pairs EHR platforms with intelligent middleware designed to coordinate workflows and drive actionable clinical decisions.
- 050RegulationSource · Medical Device Network
Coredio’s AI heart failure software secures breakthrough designation
Coredio received FDA breakthrough device designation for its AI software that monitors heart failure parameters using wearables and standard blood pressure cuffs. The designation accelerates the review pathway for the software, which analyzes physiological data to support heart failure management.
- 051New productsSource · Medical Device Network
Illumina and SPT Labtech launch fireflyGO for automated oncology research
Illumina and SPT Labtech launched fireflyGO, an automation platform designed to streamline targeted oncology research workflows. The system combines Illumina's sequencing capabilities with SPT Labtech's laboratory automation expertise to reduce manual steps and accelerate sample processing for oncology applications.
- 052TechnologySource · Healthcare IT News
Ultrasound analytics take digital transformation a step forward
Healthcare systems are adopting ultrasound analytics platforms to gain operational visibility into fleet utilization and workflow efficiency. These digital tools provide performance metrics across ultrasound departments at scale, supporting hospital digital transformation initiatives by helping optimize resource allocation and clinical scheduling.
- 053RegulationSource · Medical Device Network
Procept secures FDA IDE for Aquablation and completes WATER IV study enrolment
Procept BioRobotics received a second FDA Investigational Device Exemption (IDE) to conduct another randomized study of its Aquablation therapy, a minimally invasive procedure for benign prostatic hyperplasia. The company has completed enrollment for the WATER IV study, which will generate additional clinical data to support the technology's regulatory pathway.
- 054MarketSource · Healthcare IT News
AstraZeneca, Roche to boost digital pathology uptake in APAC and more briefs
AstraZeneca and Roche Diagnostics Asia Pacific signed a three-year memorandum of understanding to promote AI-powered digital pathology and biomarker testing for breast and lung cancer across nine Asian markets. The partnership aims to expand adoption of digital pathology solutions in the region.
- 055TechnologySource · Healthcare IT News
Australia pursues digitisation of child health records
Australia will launch development of a National Digital Child Health Record in July, integrating with My Health Record and the 1800MEDICARE app to provide families, carers, and care providers a consolidated view of pediatric health and development data across the care continuum.
- 056MarketSource · MedCity News
Walmart, Teladoc Team Up to Expand Access to Virtual Care
Walmart and Teladoc Health announced a partnership integrating Teladoc's virtual care services into Walmart's Better Care Services platform, expanding access to remote clinical consultations through the retail giant's existing consumer base and healthcare infrastructure.
- 057New productsSource · Mobi Health News
Q&A: Philips CMO on the tech giant's partnership with Disney
Philips has partnered with Disney to develop an ambient experience for children undergoing MRI procedures. The collaboration aims to reduce anxiety and improve the patient experience during diagnostic imaging by integrating Disney content and theming into the MRI environment.
- 058New productsSource · Mobi Health News
Oura unveils AI-enabled Ring 5 with predictive health features
Oura announced Ring 5, the next generation of its wearable health-tracking ring. The device is 40% smaller than Ring 4, offers one-week battery life, and features LEDs four times stronger than previous models to improve reading accuracy. New health features powered by AI are included, though specific predictive capabilities were not detailed in the announcement.
- 059RegulationSource · Medical Device Network
Abbott obtains CE mark for duo of glucose-ketone monitors
Abbott obtained CE mark approval for two glucose-ketone monitoring systems designed for diabetic patients. The CE mark clears the devices for distribution in European markets and represents regulatory advancement for Abbott's continuous glucose-ketone sensing portfolio.
- 060New productsSource · Medical Design & Outsourcing
LEMO launches REDEL P disposable connectors for medical use
LEMO introduced the REDEL P Disposable Plastic Connectors, engineered for electro-surgical and disposable medical applications. The connectors combine LEMO's Push-Pull locking system with a disposable patient-side interface designed for high-volume medical use where reliable connectivity and safe integration are priorities.
- 061TechnologySource · Mobi Health News
Can wearable data do more than track health? Singapore's Signsbeat is trying to find out
Signsbeat, a Singapore-based health tech startup, is developing a wearable-derived analytics platform that interprets physiological signals from wearables and continuous glucose monitors to provide actionable metabolic insights beyond passive health tracking. The company is testing whether correlating multiple data streams can explain the drivers behind vital-sign changes rather than simply reporting individual metrics.
- 062RegulationSource · MedCity News
How Bayesian Health’s Sepsis AI Tool Is Decreasing Alerts & Saving Lives
Bayesian Health received FDA clearance for a continuous AI-powered sepsis monitoring system, becoming the first vendor to gain approval for this type of tool. The clearance follows clinical validation and real-world deployments across multiple health systems.
- 063MarketSource · Mobi Health News
Signos raises $20M for glucose monitoring system for weight management
Signos, which makes an over-the-counter glucose monitoring system marketed for weight management, raised $20 million in funding from Dexcom, Google Ventures, and Blue Cross Blue Shield of Alabama. The funding round includes a partnership with Dexcom that will make Signos available through Dexcom's direct-to-consumer continuous glucose monitoring website.
- 064TechnologySource · Healthcare IT News
Wearables data pose a vulnerability that could undermine RPM programs
Remote patient monitoring programs using wearable devices face cybersecurity vulnerabilities that could compromise data integrity and program effectiveness, according to healthcare IT analysts. As RPM adoption grows across clinical settings, IT leaders must address encryption, authentication, and secure data transmission standards to protect patient information and maintain regulatory compliance.
- 065TechnologySource · Medical Device Network
AiM Medical to integrate robotic neurosurgery system with Siemens’ MRI systems
AiM Medical Robotics will develop an interface to integrate its robotic neurosurgery platform with Siemens Healthineers MRI systems. The partnership aims to enable real-time imaging guidance during neurosurgical procedures by connecting the two systems.
- 066RegulationSource · Medical Device Network
ABILITY Neurotech receives MREC approval for ALS BCI clinical trial
ABILITY Neurotech obtained regulatory approval from the MREC NedMec in the Netherlands to begin a chronic clinical trial of its fully implantable wireless brain-computer interface in ALS patients. The approval clears the path for human testing of the device in a European jurisdiction.
- 067MarketSource · MedCity News
Oura Files for IPO As Healthcare Ambitions Grow
Oura, maker of smart rings for health monitoring, has filed for an initial public offering as it expands beyond sleep tracking into broader healthcare applications. The move signals the company's shift from consumer wellness toward clinical-grade monitoring and reflects growing investor appetite for wearable health-tech vendors.
- 068TechnologySource · Healthcare IT News
IHH Healthcare embeds AI into workflows as adoption scales across hospitals
IHH Healthcare, a major Asia-Pacific hospital operator, is embedding AI into clinical and operational workflows across its network. The deployment focuses on improving efficiency and reducing administrative burden, with growing interest in advanced clinical AI applications. The rollout reflects broader regional momentum among healthcare organisations to adopt AI for workflow optimisation.
- 069RegulationSource · Mobi Health News
Dexcom discovers two lots of stolen G7 sensors being sold to public
Dexcom identified two lots of G7 continuous glucose monitoring sensors (lot numbers 1725204004 and 1725069002) that were designated as scrap and sent to a third party for destruction, but were instead sold to consumers. The company noted that quality-control rejects are routinely sent to vendors for destruction and recycling as part of standard practice.
- 070MarketSource · Mobi Health News
Swoop acquires Nimble expanding pharmacy connectivity services
Healthcare engagement platform Swoop has acquired prescription management platform Nimble to expand its pharmacy connectivity and medication fulfillment capabilities. The acquisition adds pharmacy integration services to Swoop's omnichannel marketing and engagement platform for life sciences vendors and healthcare providers.
- 071MarketSource · Medical Device Network
Olympus agrees $270m BioProtect buyout to expand prostate cancer offerings
Olympus has agreed to acquire BioProtect for $270 million to expand its prostate cancer treatment portfolio. BioProtect's primary product is a tissue-protection spacer system used during radiation therapy for prostate cancer. The acquisition strengthens Olympus's specialty medical and oncology device offerings.
- 072RegulationSource · Medical Device Network
CSR secures certifications in EU and Singapore for Sentire system
CSR obtained CE mark certification for its Sentire Endoscopic Surgical System under EU Medical Device Regulation, along with separate approval from Singapore's Health Sciences Authority. The clearances enable market access in both regions for the minimally invasive surgical platform.
- 073New productsSource · Medical Device Network
Hyperfine’s portable MRI system demonstrates time-saving benefit in new data readout
Hyperfine reported that its Swoop portable MRI system achieved a median imaging order-to-scan time of 6.35 hours, demonstrating faster workflow compared to conventional MRI systems. The announcement highlights operational efficiency gains for the company's point-of-care imaging platform.
- 074TechnologySource · Healthcare IT News
Singapore, Bhutan partner on rural chest X-ray AI
SingHealth (Singapore) and the Royal University of Bhutan's Gyalpozhing College of Information Technology have signed a two-year memorandum of understanding to develop an AI-assisted chest X-ray diagnostic model for rural hospitals. The collaboration aims to support lung-condition diagnosis in resource-limited settings.
- 075MarketSource · Medical Device Network
Align Technology to establish $200m manufacturing facility in India
Align Technology announced a $200 million investment to build a new manufacturing facility in Hyderabad, India, scheduled to open in 2027. The expansion marks the company's strategy to diversify production capacity and strengthen its supply chain in the Asia-Pacific region.
- 076TechnologySource · Healthcare IT News
AI's promise meets the pediatric frontline
Children's Hospital of Orange County is deploying AI tools to address clinician burden from electronic health record systems. Dr. Steven Martel leads efforts to use artificial intelligence to streamline workflows and reduce administrative overhead in pediatric care settings, representing a shift toward AI-enabled clinical software solutions.
- 077MarketSource · Healthcare IT News
Innovaccer acquires CaduceusHealth with an eye toward autonomous RCM
Innovaccer acquired CaduceusHealth for $66 million to expand its revenue cycle management platform with enhanced capabilities for addressing claim denials. The deal adds agentic AI functionality to Innovaccer's RCM offerings, targeting a key pain point for healthcare providers managing high denial rates.
- 078MarketSource · Medical Device Network
Harnessing medtech market alliances, ŌURA sets IPO plans in motion
Oura, maker of the Oura Ring wearable health device, is planning an initial public offering following a $900 million funding round completed in October 2025 that valued the company at $11 billion. The IPO announcement reflects growing investor interest in consumer-facing medtech platforms and wearable health monitoring.
- 079MarketSource · Mobi Health News
Oura confidentially files for IPO as revenue growth soars
Oura, maker of health-tracking rings, has confidentially filed for an initial public offering with the SEC, seven months after closing a $900 million funding round that valued the company at approximately $11 billion. The filing follows reported strong revenue growth for the Finnish-American wearable vendor.
- 080RegulationSource · Medical Device Network
Sentante’s endovascular robotic surgery platform secures CE mark
Sentante's endovascular robotic surgery platform has received CE mark approval, clearing the way for commercial deployment across Europe. The company plans to partner with hospitals and healthcare providers to integrate the robotic system into clinical workflows.