Curated from medtech publications. Product launches, FDA clearances, M&A, technology shifts — rewritten as short briefs, linked back to the source. Filter by theme below.
Edwards Lifesciences raised its full-year 2026 revenue growth guidance following solid second-quarter results, driven primarily by its transcatheter aortic valve replacement (TAVR) business, which generated $1.26 billion in Q2 revenues. The company's strong TAVR performance underpinned confidence in its revised outlook.
Velmeni received FDA 510(k) clearance for V4D, a 3D software platform designed for dental practitioners. The clearance enables the company to market the software in the US for dental applications.
Science Corporation received CE mark approval from DEKRA for its Prima brain-computer interface device under EU Medical Device Regulation and has begun commercial rollout in Europe. The approval clears the pathway for market distribution across EU member states.
bioAffinity Technologies partnered with Pictor to develop and commercialize diagnostic tests for asthma and chronic obstructive pulmonary disease (COPD). The collaboration combines the companies' capabilities to advance respiratory disease diagnostics, though specific product timelines and technical details were not disclosed.
The American Heart Association's Impact Report, generated through its AI Assessment Lab using independent clinical and imaging data, highlights benefits of Ultromics' AI tool for earlier heart failure diagnosis. The tool leverages AI to improve diagnostic timing and accuracy in cardiac assessment.
Johnson & Johnson's MedTech division secured FDA de novo clearance for Ottava, its surgical robotics platform. The company plans an initial launch with select customers, marking J&J's entry into the competitive surgical robotics market.
Arterex Tecate, a medical device contract manufacturer, opened a 9,000-square-foot ISO Class 8 clean room facility. The expansion increases manufacturing capacity for medical devices and demonstrates the company's investment in quality and regulatory compliance infrastructure.
A report addresses engineering challenges in integrating sensors into remote patient monitoring devices, covering sensor integration, signal integrity, feedthrough reliability, and materials durability. The analysis targets suppliers and engineers developing homecare monitoring solutions.
TYBR Health secured $30 million in funding to expand market access for its B3 GEL orthopaedic hydrogel, which launched in the US in January 2026. The company plans to use the capital primarily to grow distribution and market penetration of the platform.
Hilo, a health technology brand developed by Aktiia, has launched its Hilo Core blood pressure monitoring system in the US market. The system represents a new product entry in the remote patient monitoring and vital signs space.
Nelipak Corporation, a healthcare packaging solutions provider, released its 2025 Sustainability Report detailing progress toward long-term sustainability goals and product innovations. The report aligns with the company's stated vision to support sustainable healthcare practices through packaging solutions.
Philips received 510(k) FDA clearance for a next-generation reusable SpO₂ (blood oxygen saturation) clip sensor. The device enables non-invasive patient monitoring and represents a product iteration within Philips's portfolio of patient monitoring solutions.
As AI capabilities integrate deeper into Class II and III medical devices, manufacturers face mounting questions about clinical risk ownership and accountability. The article examines how design and development decisions made years before deployment can create downstream trust and safety issues, and offers guidance for medtech teams to establish clear responsibility frameworks for AI-driven device outputs.
Cardinal Health acquired Strive Medical and Adapt Health's diabetes unit in two deals totaling $360 million to expand its home care business. The acquisitions strengthen Cardinal Health's portfolio in at-home medical device and diabetes management services, supporting its stated growth strategy in the home care sector.
Medical devices cleared for clinical use often remain in service for 15+ years while their embedded software ages without patches, creating security vulnerabilities. The article discusses challenges of securing long-lifecycle devices as new threats emerge, open-source components become outdated, and attack techniques evolve, with commentary on emerging AI tools for device protection.
Tempus AI acquired Personalis for $1.5 billion in an all-stock deal focused on precision oncology. Personalis' minimal residual disease (MRD) testing platform will be integrated into Tempus' oncology portfolio, expanding the combined company's diagnostic and data capabilities in cancer care.
Fresenius Medical Care launched TherapyWise, a cloud-based analytics platform designed to support hospital and critical care teams managing kidney replacement therapy (KRT) in the US. The platform enables real-time data analysis and clinical decision support for dialysis and renal care providers.
ARUP Laboratories launched CLARISPECT Multiple Myeloma MRD, a spectral flow cytometry assay for detecting minimal residual disease in multiple myeloma patients. The assay represents a clinical offering from ARUP's diagnostic laboratory services and is designed to support treatment monitoring and patient stratification in hematologic malignancy care.
Enable Injections' enFuse on-body injector (OBI) platform achieved its second FDA approval in July 2026 when Sanofi received clearance for an anticancer treatment using the device. The enFuse system previously secured its first combination product approval in 2023 for paroxysmal nocturnal hemoglobinuria. The platform represents a first-of-its-kind wearable drug delivery technology in the oncology space.
Hospital IT security leaders are grappling with dual-use AI risks as healthcare systems deploy machine learning for clinical care while adversaries exploit the same technologies for cyberattacks. Karen Habercoss, CISO at University of Chicago Medicine, discussed governance frameworks needed to manage AI-driven security threats targeting health systems and patient data.
Tempus AI announced a $1.5 billion acquisition of Personalis, a liquid biopsy company specializing in minimal residual disease (MRD) assays that detect remaining cancer cells after treatment. Tempus has served as the commercial partner for Personalis's MRD test since 2023. The deal consolidates two players in the growing cancer diagnostics market.
Medline announced plans to open a 1-million-square-foot distribution facility in Perris, California, expanding its logistics network following a similar buildout in Texas. The facility is intended to increase capacity and operational flexibility for healthcare providers across the state.
GE HealthCare launched a remote workflow access tool for MIM (medical imaging management) systems designed to enable imaging workflow collaboration among specialist teams, particularly in oncology. The tool is intended to streamline coordination between different departments working with imaging data.
A MedCity News analysis examines how patent strategy, FDA regulation, and HIPAA privacy requirements create competing pressures for healthcare AI developers. The piece argues that vendors who align these three legal frameworks from inception—rather than addressing them sequentially—will gain competitive advantage in bringing AI-enabled medical devices and software to market.
BRIJ Medical has commercially launched BRIJ-SEAL, a wound sealant designed to seal and protect surgical incisions following surgery. The product addresses post-operative wound management in the operating room and recovery settings.
The British Business Bank has committed €25 million to EQT Life Sciences' latest fund. The Bank has prior co-investment experience with EQT portfolio companies Phagenesis and Cyted Health, signaling continued backing of the venture capital firm's life-sciences investments.
VahatiCor has developed the A-Flux, an investigational nitinol implant designed to treat coronary microvascular dysfunction (CMD), a condition in which coronary arteries fail to dilate properly, restricting blood flow to the heart and causing chest pain, shortness of breath, and fatigue without major arterial blockages. The implant addresses a patient population currently lacking targeted interventional options.
PTC announced Onshape Labs, an early-access program integrating AI into its cloud-based product development platform. The initiative enables engineering teams to evaluate emerging AI capabilities within design workflows, using real-time product data to automate tasks and improve design decisions. Broader availability is planned for summer 2024 via opt-in access.
HiArc will exhibit its Ctrl platform at ADLM 2026 in Anaheim in July. Ctrl is an integrated hardware and software platform designed to accelerate development of medical devices and diagnostic systems. The company will showcase the offering at booth 3555.
Bayesian Health commercialized a noninvasive sepsis monitoring software as a medical device (SaMD) developed at Johns Hopkins University and received FDA clearance. The AI/ML-based system is the first continuous sepsis monitoring platform of its kind to earn clearance and reportedly detects sepsis hours earlier than conventional clinical assessment.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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