- 201New productsSource · Medical Design & Outsourcing
Why Microbot Medical thinks it can win the stroke telesurgery race
Microbot Medical received FDA 510(k) clearance in September 2025 for its Liberty robotic system, a fully disposable, single-use endovascular navigation device designed for remote delivery and manipulation of guidewires and catheters. The company is positioning Liberty as a contender in the telesurgery market, particularly for stroke intervention applications.
- 202New productsSource · MedCity News
Why Settle for Acceptable Versus Optimal Outcomes?
A new 3D printing technology enables lower extremity surgeons to design and customize surgical solutions rather than rely on standard off-the-shelf approaches. The technology positions surgeons as architects of patient restoration, allowing more precise surgical planning and implant customization for orthopedic procedures.
- 203MarketSource · Medical Device Network
RapidPulse obtains funding for stroke aspiration system
RapidPulse secured $48 million in funding to advance clinical development of its aspiration technology for acute ischemic stroke treatment. The capital will support the company's efforts to move the system through clinical validation and toward market commercialization.
- 204MarketSource · Medical Device Network
GE and Catholic Health enter $500m alliance to expand diagnostics access
GE HealthCare and Catholic Health have formed a 10-year strategic alliance valued at approximately $500 million to expand precision diagnostics, advanced imaging, and AI-supported technology across Catholic Health's Long Island network. The partnership aims to increase access to diagnostic capabilities and modernize imaging infrastructure within the health system.
- 205New productsSource · Medical Design & Outsourcing
Prosthetics developer Metacarpal seizes on reliability
Metacarpal, a prosthetics developer, has launched what co-founder Fergal Mackie describes as the first multi-articulating, body-powered prosthetic hand. The company is positioning reliability and user trust as its core differentiator, citing the prosthetics industry's history of device failures and user disappointment rather than technological limitations as the primary market challenge.
- 206New productsSource · Medical Design & Outsourcing
Sensors on surgeons helped J&J’s DePuy Synthes sell a new tool
Johnson & Johnson's DePuy Synthes used surface electromyography sensors placed on surgeons to quantify the clinical benefits of its Kincise Surgical Automated System for total hip arthroplasty. The sensor data, which measured surgeon muscle fatigue and workload, provided evidence supporting the product launch in 2020 and demonstrated measurable improvements over traditional manual techniques.
- 207MarketSource · Medical Device Network
DePuy Synthes expands spine portfolio after Expanding Innovations acquisition
DePuy Synthes acquired Expanding Innovations, gaining access to the company's interbody cage systems for complex spinal surgery. The deal expands DePuy Synthes' spine portfolio.
- 208MarketSource · Medical Device Network
Neko Health raises $700m as US market entry draws closer
Neko Health secured $700 million in funding as the Swedish health-screening company prepares to enter the US market with its first location in New York this year, followed by additional US sites. The funding round supports the company's expansion beyond its existing Scandinavian operations into the American medical-device and diagnostic-screening sector.
- 209MarketSource · Medical Device Network
BIOTRONIK Neuro acquires Soin Neuroscience’s SCS IP portfolio
BIOTRONIK Neuro has acquired an intellectual property portfolio from Soin Neuroscience focused on spinal cord stimulation (SCS) technology. The deal expands BIOTRONIK's neuromodulation capabilities and IP footprint in the SCS market.
- 210New productsSource · Medical Device Network
Smith+Nephew unveils Lynx Coblation Laryngeal Wand for laryngology
Smith+Nephew has launched the Lynx Coblation Laryngeal Wand, a surgical device designed for laryngology procedures performed by ENT surgeons. The wand uses coblation technology for tissue ablation and coagulation in the larynx.
- 211MarketSource · 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.
- 212TechnologySource · 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.
- 213TechnologySource · 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.
- 214MarketSource · 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.
- 215TechnologySource · 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.
- 216MarketSource · 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.
- 217MarketSource · 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.
- 218RegulationSource · 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.
- 219MarketSource · 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.
- 220MarketSource · 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.
- 221MarketSource · 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.
- 222TechnologySource · 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.
- 223New 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.
- 224RegulationSource · 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.
- 225RegulationSource · 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.
- 226MarketSource · 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.
- 227RegulationSource · 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.
- 228RegulationSource · 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.
- 229MarketSource · 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.
- 230MarketSource · 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.
- 231RegulationSource · 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.
- 232MarketSource · 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.
- 233TechnologySource · 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.
- 234RegulationSource · 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.
- 235RegulationSource · 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.
- 236RegulationSource · 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.
- 237MarketSource · 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.
- 238MarketSource · 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.
- 239TechnologySource · 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.
- 240MarketSource · 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.