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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Swiss spine surgery company Neo Medical launched its Instant MIS Access platform commercially in the US market. The platform is designed to facilitate minimally invasive surgical access procedures.
Natera presented data demonstrating clinical benefit of its minimal residual disease (MRD) test in colorectal cancer patients at the 2026 ESMO Gastrointestinal Congress in Munich. The test, which detects circulating tumor DNA, showed prognostic value in identifying patients at risk of recurrence. The findings support the diagnostic utility of Natera's MRD assay in post-treatment monitoring of colorectal cancer.
Xeltis has enrolled over 50% of target patients in its US pivotal trial for aXess, a vascular access device for adults with end-stage renal disease requiring hemodialysis. The milestone marks progress toward regulatory submission for the device.
Boston Scientific is developing the Farawave Ultra, a third-generation pulsed-field ablation catheter planned for launch in the first half of 2027. The device will expand the Farapulse system portfolio following the January 2024 FDA clearance of the second-generation Farawave PFA catheter. The Ultra variant represents the company's next iteration in the PFA ablation market.
OrthAlign completed initial clinical procedures using its Lantern ASC system, a surgical platform designed for ambulatory surgery center environments. The milestone marks the first in-use validation of the system following development.
Hyperfine has launched the next-generation Swoop portable MRI system (Model 2) in select European markets. The device represents an update to the company's portable MRI platform, expanding its commercial availability beyond the US market.
VahatiCor, led by CEO Harry Rowland (who previously sold Endotronix to Edwards Lifesciences), is developing the A-Flux reducer system to treat coronary microvascular dysfunction, a condition currently managed only with medication. The device targets patients without existing interventional options for chest pain relief.
GE HealthCare announced upgrade pathways that allow customers with existing interventional suites to transition to new technologies. The initiative is designed to simplify modernization for facilities seeking to refresh their imaging and procedural capabilities in interventional settings.
Terumo Interventional Systems completed the first US clinical procedure using its Opuswave Dual Sensor Imaging System. The system represents a product advancement in interventional imaging technology, enabling dual-sensor visualization capabilities for guidance during minimally invasive procedures.
Roche launched Axelios 1, a next-generation sequencing platform powered by its SBX technology. The system is available for research use, marking an expansion of Roche's sequencing portfolio and supporting genomic analysis applications in laboratory and research settings.
XCath announced its Iris robotic telesurgical system for remote stroke treatment, claiming a competitive advantage after completing the first remote mechanical thrombectomy over 120 miles away. The system targets the stroke intervention market, where telesurgery capability could expand access to time-critical endovascular procedures beyond centers with on-site specialist availability.
Johnson & Johnson has begun enrollment in the SKYWARD IDE clinical study to evaluate the Shockwave SkyRunner Carotid IVL (Intravascular Lithotripsy) system. The trial will assess the device's safety and effectiveness for treating calcified carotid artery disease.
MIT researchers have developed a miniaturized ingestible temperature sensor (MITS) measuring 4 mm tall and 6 mm wide—roughly blueberry-sized—designed to continuously monitor core body temperature from the gastrointestinal tract. The device is smaller than existing ingestible temperature sensors, reducing swallowing difficulty and aspiration risk. The advancement addresses a gap in non-invasive continuous core temperature monitoring for clinical and research applications.
MGS launched hybrid tooling technology to accelerate injection-molded prototyping and validation for medical device manufacturers. The offering enables faster development cycles and reduces manufacturing risk by supporting global healthcare product development workflows.
CereVasc has completed patient enrollment in the STRIDE clinical trial evaluating its eShunt system for normal pressure hydrocephalus (NPH). The study assesses safety and efficacy of the device ahead of regulatory submissions.
Labcorp announced US availability of ColoSense, an FDA-approved RNA-based at-home screening test for colorectal cancer. The test expands Labcorp's diagnostic offering in the colorectal cancer screening market, bringing an alternative to existing screening modalities.
Midjourney, a generative AI company, announced plans to launch its first AI-powered medical imaging facility in 2027 offering whole-body ultrasonic CT scans. The system uses sound and water to complete imaging in 60 seconds without radiation or magnetic fields, positioning it as an alternative to traditional CT and MRI modalities. The facility will operate as a medical imaging spa model.
Junkosha announced winners of its Technology Innovator of the Year Award. Anchor Balloon Inc. founder Dr. Vishal Gupta received the $25,000 late-phase award for the AngioLock coronary balloon catheter, a device designed to stabilize and simplify stent delivery in complex coronary anatomy. The award recognizes medical device developers working with Junkosha on innovative technologies.
BCAL Diagnostics is developing BREASTEST Monitor, a blood test designed to help evaluate women for local breast cancer recurrence following treatment. The test aims to provide a non-invasive monitoring option for post-treatment breast cancer patients.
LivaNova announced a proprietary PolySync algorithm that reconfigures proximal hypoglossal nerve stimulation (p-HGNS) fields to improve response rates in sleep apnea patients. The algorithm represents a software enhancement to the company's existing hypoglossal nerve stimulation therapy platform.
Remedy Robotics is positioning its N1 System as a competitive offering in the emerging stroke telesurgery market, joining established OEMs and other startups pursuing robotic remote surgical intervention for acute stroke treatment. The company claims early momentum in a segment seen as a major growth opportunity for medical device vendors.
Raydiant Oximetry has completed enrolment and data collection for a 15-patient pilot study at Louisiana State University Health Sciences Center. The study evaluates the company's oximetry technology in a clinical setting.
Dimora Medical launched MegaSorb technology for silicone foam dressings, a new wound-care consumable product designed to improve absorption in advanced wound management applications.
Zeus announced XpanCore, a heat-activated mandrel technology designed to simplify hypotube assembly in catheter manufacturing. The mandrels address liner sizing, placement, and adhesion challenges in advanced catheter production, expanding Zeus's polymer solutions portfolio for medical device manufacturers.
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