- 041MarketSource · MedCity News
Neko Health Secures $700M to Support US Expansion
Neko Health secured $700 million in Series C funding co-led by Lightspeed Venture Partners and O.G. Venture Partners to support US expansion. The round included participation from Atomico, General Catalyst, Lakestar, Liberty City Ventures, Positive Sum, and BDT & MSD. Neko operates diagnostic imaging and health-screening services, positioning itself as a vendor in the preventive diagnostics and mobile imaging space.
- 042TechnologySource · Medical Design & Outsourcing
Designing SaMD for safety and rethinking risk management through system architecture
A Medtronic-authored piece examines software-as-a-medical-device (SaMD) safety design and risk management practices, proposing a workflow-centric, slice-based architectural approach to improve hazard visibility and traceability across the product lifecycle. The article discusses alignment with ISO 14971 standards and challenges in implementing effective controls despite established regulatory frameworks.
- 043TechnologySource · MedCity News
Answers at the Speed of Thought: Healthcare Analytics in the Era of Agentic AI
Healthcare organizations are adopting agentic AI systems that enable natural-language queries of clinical and operational data, moving beyond traditional spreadsheet-based analytics. These systems allow users to ask questions about denial patterns, safety profiles, and other metrics and receive direct answers. The shift reflects broader adoption of conversational AI interfaces in health IT workflows.
- 044MarketSource · Medical Device Network
J&J raises FY26 outlook following positive Q2
Johnson & Johnson raised its fiscal 2026 outlook following strong second-quarter results, with MedTech contributing $8.9 billion of the division's $25.3 billion in total Q2 revenues. Growth was driven in part by its cardiovascular portfolio, including the Shockwave IVL lithotripsy system.
- 045TechnologySource · MedCity News
Off the Radar: How Unapproved AI Is Complicating Healthcare Cyber Risk
Healthcare organizations are deploying unapproved AI tools without visibility or oversight, creating hidden cybersecurity vulnerabilities that cannot be easily detected or managed. The proliferation of shadow AI—software not sanctioned by IT or security teams—expands the attack surface and complicates compliance and risk management across healthcare systems.
- 046MarketSource · Medical Device Network
Women’s health attracted record equity in 2025 as companies share capital
Women's health companies attracted record equity funding in 2025 as investors increased capital allocation to the sector. The surge reflects growing recognition that closing gender health gaps could add over $1 trillion annually to the global economy by 2040, driving venture and growth capital toward female-focused medical device and diagnostic companies.
- 047MarketSource · Medical Device Network
THINK Surgical nets up to $65m with Symbiotic Capital debt facility
Think Surgical secured a debt facility of up to $65 million from Symbiotic Capital. The company's flagship product is TMINI, a handheld robotic system for total knee arthroplasty procedures. The financing will support the company's operations and growth.
- 048RegulationSource · Medical Device Network
Newronika’s aDBS system secures CE mark with cloud data integration
Newronika obtained CE mark approval for its αDBS adaptive deep brain stimulation system, which includes cloud-based data integration capabilities. The clearance allows commercial distribution of the neurostimulation platform in European markets.
- 049MarketSource · Medical Device Network
Neuraptive secures exclusive licence from Washington University for nerve device
Neuraptive Therapeutics has secured an exclusive licence from Washington University in St. Louis for a bioresorbable wireless electronic stimulation device designed for peripheral nerve repair. The deal grants Neuraptive rights to commercialize the technology, which represents a strategic licensing partnership in the neurology device space.
- 050MarketSource · Medical Design & Outsourcing
Ultrasound CDMO Vermon opens new plant and buys subsystem specialist
Vermon, a Tours, France-based ultrasound contract manufacturer, opened a new 30,000-square-foot TransducerWorks facility in Pennsylvania—four times larger than its predecessor and equipped with ISO 7 and ISO 8 cleanrooms and integrated machine shop—and acquired Modeleus, an OEM ultrasound subsystem specialist, to establish the Vermon Group platform.
- 051MarketSource · Medical Device Network
Edwards Lifesciences served $10m penalty over JC Medical acquisition violations
Edwards Lifesciences was ordered to pay a $10 million penalty after a court found the company violated antitrust law requirements in its 2024 acquisition of JC Medical. The FTC enforcement action followed a ruling that Edwards failed to comply with merger conditions.
- 052TechnologySource · MedCity News
Why the Next Era of Sleep Medicine Depends on Better Diagnostics
Sleep medicine is shifting toward diagnostic approaches that identify the underlying drivers of apnea rather than just measuring frequency. This shift requires rethinking how and where sleep apnea testing occurs to better match patients with appropriate therapies, reflecting broader changes in diagnostic strategy and testing modalities within the specialty.
- 053New productsSource · Medical Device Network
AAIC26: Cognito sheds light on biological underpinnings of Alzheimer’s headset
Cognito, a neuromodulation headset for Alzheimer's disease, showed biological effects in a presentation at AAIC26. The device increased cerebrospinal fluid levels of HDL-like lipid transport proteins, indicating a coordinated biological response to the therapy. The finding provides mechanistic evidence for how the headset may work at a cellular level.
- 054RegulationSource · Medical Device Network
Health Canada authorises Dexcom G7 15 Day CGM
Health Canada has authorized the Dexcom G7 15 Day continuous glucose monitoring system for adults 18 and older with diabetes. The approval expands availability of the device in the Canadian market.
- 055RegulationSource · Medical Device Network
Claria Medical secures FDA De Novo classification for hysterectomy device
Claria Medical received FDA De Novo classification and marketing authorization for its Claria System, a device that supports tissue extraction during minimally invasive hysterectomy procedures. De Novo classification establishes a new regulatory pathway for the device type.
- 056MarketSource · Medical Design & Outsourcing
Nitinol supplier Fort Wayne Metals sold
Axel Johnson Inc. has acquired Fort Wayne Metals and its parent company Fort Wayne Metals Research Products. The nitinol supplier, founded in 1970 and based in Fort Wayne, Indiana, will remain headquartered at its current location under new ownership. Financial terms were not disclosed.
- 057RegulationSource · Medical Device Network
HistoSonics’ Edison histotripsy system obtains CE mark
HistoSonics announced CE mark approval for its Edison histotripsy system, a therapeutic ultrasound device for liver tumour treatment. The company plans a phased commercial rollout across European centres of excellence specialising in hepatic oncology.
- 058RegulationSource · Medical Device Network
FDA clears Zeta Surgical’s robotic TMS navigation system
The FDA has cleared Zeta Surgical's robotic navigation system for transcranial magnetic stimulation (TMS), a non-invasive brain stimulation technique used to treat depression, behavioral disorders, and addiction-related conditions. The robotic system enhances precision and consistency in TMS coil placement and targeting during treatment delivery.
- 059MarketSource · Medical Device Network
En Carta secures $6.18m to expand molecular testing solutions
En Carta Diagnostics closed €5 million ($6.18 million) in funding to expand its at-home molecular diagnostic solutions. The financing will support scaling of the company's testing platform for consumers and clinical applications.
- 060MarketSource · Medical Device Network
Virax Biolabs enters immune profiling product supply deal with Fosun
Virax Biolabs signed an exclusive commercial supply agreement with Fosun Diagnostics to distribute its ImmuneSelect immune profiling product line. The deal covers research-use-only applications of the immune profiling platform.
- 061RegulationSource · Medical Design & Outsourcing
Sentante has a CE mark, its CEO says much more to come for endovascular robotics
Sentante, a developer of remote endovascular robotics systems, obtained CE mark approval in May, clearing the way for commercial deployment in Europe. The company's CEO stated the clearance positions Sentante to move into commercialization and deliver the robotic platform to clinicians.
- 062MarketSource · Medical Device Network
Otsuka ICU Medical outlays $500m to expand US manufacturing footprint
Otsuka ICU Medical announced a $500 million investment to expand its US manufacturing capacity, including construction of a new facility and upgrades to its existing Austin, Texas site. The expansion reflects the company's commitment to domestic production and supply-chain resilience for its medical device portfolio.
- 063TechnologySource · MedCity News
Preventing Medical Errors in Patient Identity Through Data Matching, VBC, and Interoperability Standards
A webinar sponsored by Verato brought together executives from Providence and Yale New Haven Health System to discuss patient identity data matching, vendor-based credentialing (VBC), and interoperability standards as mechanisms for reducing medical errors. The discussion addressed challenges in sharing electronic patient data across increasingly complex healthcare networks.
- 064RegulationSource · Medical Device Network
FDA clears iHealthScreen’s AI diabetic retinopathy screening software
iHealthScreen received FDA clearance for AI software that analyzes diabetic retinopathy from images captured by the iCare DRSplus camera, a device already deployed in US ophthalmology clinics and optician practices. The clearance enables the software to support screening workflows in existing imaging environments.
- 065RegulationSource · Medical Device Network
Roche secures CE Mark for Elecsys test to detect tuberculosis
Roche obtained CE Mark approval for its Elecsys IGRA TB blood-based test, which detects latent tuberculosis infection in routine laboratory settings. The test is now cleared for use in European markets.
- 066RegulationSource · Medical Device Network
TRiCares begins US IDE pivotal trial of TTVR system
TRiCares SAS has enrolled and treated the first patient in the TRICURE US IDE pivotal study of its Topaz TTVR (transtricuspid valve replacement) system. The trial is progressing toward FDA clearance for the transcatheter device, which addresses tricuspid regurgitation in patients ineligible for conventional surgery.
- 067MarketSource · MedCity News
IKS Health Beefs Up Its Tech Stack with $557M Acquisition of TruBridge
IKS Health acquired TruBridge for $557 million, integrating the EHR and revenue-cycle management vendor into its AI-powered care platform. The deal marks IKS Health's third acquisition in 2026 and expands its footprint in rural-hospital IT services.
- 068MarketSource · Medical Device Network
GE HealthCare and Mayo Clinic partner for new theranostics research study
GE HealthCare and Mayo Clinic have announced a partnership to conduct a theranostics research study focused on radioligand therapy. The collaboration will evaluate how imaging and biomarker data can inform personalized treatment approaches using RLT, combining diagnostic insights with targeted therapeutic delivery.
- 069TechnologySource · MedCity News
Brain Interfaces Don’t Need Surgery to Be Transformative – and the Distinction Is Now a Strategic One
Non-surgical brain-computer interfaces (BCIs) are increasingly matching the performance of surgical alternatives while reducing procedural risk, shifting the strategic landscape of BCI development. The distinction between surgical and non-surgical approaches now carries significant implications for vendors and adoption pathways in neurological device markets.
- 070MarketSource · Medical Device Network
Leo Cancer Care raises $65m for upright radiotherapy platform
Leo Cancer Care raised $65 million in funding for its Marie radiotherapy platform, an upright positioning system paired with CT imaging for proton therapy delivery. The system received FDA clearance in July 2025. The funding supports commercialization of the platform, which addresses workflow and patient positioning in radiation oncology.
- 071RegulationSource · Medical Device Network
Johnson & Johnson’s DE STSF platform secures FDA approval
Johnson & Johnson received FDA approval for its Dual Energy Thermocool Smarttouch SF Platform (DE STSF), a radiofrequency ablation system. The platform is designed for cardiac arrhythmia treatment and incorporates dual-energy technology with the company's Smarttouch contact-force sensing capability.
- 072New productsSource · Medical Device Network
Philips expands ultrasound portfolio with AI-driven Alturion
Philips launched the Alturion ultrasound system, an AI-enabled platform designed for high-volume clinical settings. The system incorporates artificial intelligence-driven workflows to support diagnostic imaging operations.
- 073RegulationSource · Medical Design & Outsourcing
FDA releases draft MDUFA VI agreement outlining proposed legislation and program changes
The FDA released a draft Medical Device User Fee Amendments (MDUFA) VI commitment letter outlining proposed changes to its device review program. The draft includes a faster pre-submission track, earlier communication for de novo applicants, and a new international harmonization pilot program. MDUFA VI represents the agency's reauthorization agreement with the medtech industry.
- 074New productsSource · Medical Design & Outsourcing
Why Navigantis thinks it can win the stroke telesurgery race
Navigantis is positioning its VASCO interventional robotic platform as a contender in the emerging stroke telesurgery market. The system is currently in clinical trials for neurointerventional procedures. The company joins established OEMs and early-stage startups competing to enable remote treatment of stroke patients, a segment viewed as a significant opportunity in medical technology.
- 075MarketSource · Medical Device Network
Resmed sharpens sleep care focus with $490m software business sale
ResMed sold MatrixCare, its software business, to private-equity firm Frazier Healthcare Partners for $490 million, less than a decade after acquiring it for $750 million. The divestment reflects ResMed's strategic pivot to concentrate on its core sleep and respiratory care device portfolio.
- 076MarketSource · Medical Device Network
Ottobock expands neuro-orthotics portfolio with Fesia Technology acquisition
Ottobock acquired Fesia Technology to expand its neuro-orthotics offerings. The deal brings Fesia's portfolio of functional electrical stimulation (FES) products used in neurorehabilitation into Ottobock's product line, strengthening its position in the neurological rehabilitation device market.
- 077MarketSource · Medical Device Network
VB Spine to acquire rights to Augmedics’ CT-Fluoro technology
VB Spine has signed a definitive agreement to acquire exclusive rights to Augmedics' CT-Fluoro technology for spine surgery applications. CT-Fluoro combines computed tomography and fluoroscopy imaging to guide surgical procedures. The acquisition expands VB Spine's intraoperative imaging portfolio for spinal intervention.
- 078RegulationSource · Medical Device Network
First patient enrolled in AtaCor’s ALARION-EV trial of EV-ICD system
AtaCor Medical has enrolled the first patient in its ALARION-EV pivotal trial, evaluating an investigational extravascular implantable cardioverter-defibrillator (EV-ICD) system. The trial represents a key regulatory milestone toward potential FDA clearance for the device, which aims to offer an alternative to traditional transvenous ICD implantation.
- 079RegulationSource · Medical Device Network
Beckman Coulter’s Alzheimer’s blood test obtains CE mark
Beckman Coulter received CE mark approval for a blood-based assay measuring phosphorylated tau (pTau217) levels in patients with cognitive decline. The test enables earlier detection and monitoring of Alzheimer's disease through a minimally invasive diagnostic approach.
- 080MarketSource · Medical Device Network
Alcon spends up to $200m to co-develop customisable cataract lenses with RxSight
Alcon and RxSight announced a co-development partnership valued at up to $200 million to create a tunable presbyopia-correcting intraocular lens (PCIOL) for cataract patients. The collaboration combines Alcon's surgical expertise with RxSight's light-adjustable lens technology to deliver customizable vision correction after implantation.