MedTech Weekly News | Week 25 2025 🗞️
A week rich with fresh capital, game-changing clearances, bold clinical firsts and a cascade of senior moves. Funding news leads the way; leadership changes close the report.
Capital, Grants and Transactions 💰
• Corvia Medical added 55 million USD to complete REDUCE-HF, the pivotal trial of its atrial shunt for heart-failure with preserved ejection fraction.
• Atraverse Medical collected 29.4 million USD to accelerate United States rollout of HOTWIRE, a radio-frequency guidewire already used in more than one thousand left-heart access procedures.
• EBR Systems secured 13 million USD through an oversubscribed share-purchase plan, lifting new money this quarter to 49 million USD for the WiSE leadless CRT system’s limited launch in 2025.
• Ceryx Medical lifted total funding to 15 million USD to advance its breathing-synchronised pacing technology.
• Adialante won a 1.18 million USD National Science Foundation SBIR Phase II award to miniaturise its silent low-field MRI scanner for emergency and intensive-care settings.
• Berkshire Biomedical received a two-phase National Institutes of Health Fast-Track grant worth up to 2.9 million USD to study COPA, a secure take-home methadone dispenser aimed at boosting treatment retention.
• Lifecare ASA raised 17 million NOK through warrant exercises, funding scale-up of its continuous-glucose micro-sensor.
• Koios Care closed a 1 million EUR seed round to develop its Parkinson real-world-data platform.
• DESKi brought in 6 million USD for HeartFocus, an AI guide for cardiac ultrasound; PointCaré raised 1.45 million EUR for critical-care analytics.
• Fallouh Healthcare secured a 305 thousand GBP Innovate UK grant to prototype PerDeCT, a bedside tamponade detector.
• OSSTEC received Innovate UK funding to build real-time quality assurance for electron-beam-printed orthopaedic implants (amount undisclosed).
• Genesys Capital announced the final close of Genesys Ventures IV, its largest health-tech fund to date, focused on North-American devices and digital care.
• Instrumentum acquired infection-detection company SPDx from cultivateMD, expanding its orthopaedic-infection portfolio.
• bioMérieux signed a definitive agreement to buy Day Zero Diagnostics, bringing rapid next-generation sequencing pathogen identification into its global microbiology business.
Regulatory Clearances and Product Launches ✅
• FDA cleared the Brain Navi NaoTrac autonomous stereotactic robot, which blends optical tracking, augmented reality and AI planning to reduce cranial procedure time.
• InspireMD gained the first EU-MDR certificate for a carotid stent with CGuard Prime, whose MicroNet mesh captures emboli while preserving flow.
• GI Windows Surgical secured FDA clearance for Flexagon, a self-forming magnet pair that creates a secure bowel anastomosis without sutures or staples.
• Viz.ai earned the agency’s first automated subdural-volume clearance with Viz Subdural Plus, which labels haemorrhage layers and midline shift in under two minutes.
• Levita Magnetics expanded indications for its MARS platform to bariatric and hiatal-hernia repair and introduced a high-BMI magnetic grasper.
• ANACONDA Biomed obtained CE Mark for ANA5, a funnel catheter that adapts to vessel size to minimise distal emboli during stroke thrombectomy.
• Neuspera Medical became the first company to secure full FDA approval for a battery-free sacral neuromodulation system for urinary urge incontinence.
• Exo received two FDA clearances for on-probe AI that detects pleural effusion and pneumothorax on the Iris ultrasound probe.
• Bracco Imaging and Subtle Medical earned CE Mark for AiMIFY, deep-learning software that doubles lesion-to-background contrast in brain MRI.
• Cube Click gained FDA clearance for SMILE Dx, cloud dental AI that flags caries and bone loss from radiographs in thirty seconds.
• Inquis Medical secured FDA clearance for the AVENTUS thrombectomy system, combining aspiration and nitinol baskets for large pulmonary embolism.
• Johnson & Johnson MedTech launched the VOLT plating line for distal-radius and proximal-humerus fractures, featuring variable-angle locked screws.
• Philips unveiled Flash 5100, a point-of-care ultrasound cart with 4K imaging and AI beam-forming that boots in five seconds.
• SS Innovations performed the first coronary bypass in the Western Hemisphere using the table-top Mantra 3 robotic system.
• FineHeart received French ANSM approval to start the first-in-human study of FlowMaker, a fully implantable pulsatile assist device that preserves native ejection.
• Gradient Denervation Technologies entered the FDA TAP programme to accelerate its ultrasound-ablation therapy for pulmonary hypertension.
• Terapet SA achieved ISO 13485 certification for Qualγscan, a system that verifies proton-beam range in real time.
• OSSIO released 2.5-millimetre bio-integrative suture anchors that fully convert to native bone within nine months while offering fifty-five percent greater pull-out strength than metal anchors.
• Inovus Medical expanded LapAR with mesocolic-dissection and cholecystectomy modules that generate quantitative performance metrics for residents.
• Suturion began United States distribution of SutureTOOL through Gore, allowing standardised abdominal-wall closure in one minute.
• Sentante demonstrated a fully remote cerebral thrombectomy across 1 600 kilometres using a 5 G link and haptic robotics.
• PharmaSens and Sibionics formed a cross-border collaboration to merge continuous-glucose sensing with a wearable insulin patch pump.
• Aether Biomedical unveiled Zeus S, an eight-motor bionic hand with adaptive-grip algorithms, Bluetooth updates and a twelve-hour hot-swap battery.
Clinical and Community Highlights 🩺
• Aethlon Medical treated a second solid-tumour patient in Australia with its Hemopurifier, observing a marked drop in tumour-derived exosomes.
• Adona Medical completed ninety-day follow-up on every participant in its first atrial-flow-regulator study, reporting no device-related complications after planned secondary interventions.
• The MedTech Innovator Asia Pacific 2025 accelerator convened twenty-five young companies in the Bay Area for investor-led workshops and pitch sessions.
• Nuclear-medicine researcher Alan Perkins received an MBE for services to patient care, a milestone celebrated by Serac Life Sciences whose Seracam imaging platform he co-invented.
Leadership Movements 👥
• Bart Bandy became chief executive of Solenic Medical, charged with commercialising alternating-magnetic-field therapy that sterilises infected implants.
• Jason Bottiglieri took the role of United States president at IMDS to build trial centres for transcatheter tricuspid repair.
• Maximilian Ries succeeded Wolfgang Ries as chief executive at joimax while the founder moved to executive chair.
• Jim Alecxih assumed command of Virtual Incision and accepted a board seat at DH Medical.
• Lena Höglund joined the Monivent board to steer neonatal ventilation products through reimbursement.
• Martijn van Lavieren PhD became head of clinical strategy at Medis Medical Imaging to globalise QFR physiology software.
• Chris Cronin signed on as board advisor to Comphya to guide United States market entry for erectile-dysfunction neuromodulation.
• Laura Conquergood was appointed chief executive and president at Baylis Medical Technologies.
• Maria Kristina Bartolo PhD advanced to chief executive of Orthonika where she will lead first-in-human testing of a soft meniscus replacement.
• Shon Chakrabarti MD MPH joined Recor Medical as chief medical officer to drive ultrasound renal-denervation trials.
• Holger Kayser became international sales director at Seramun Diagnostica.
• Maite Malet and Isabel Jiménez Bernal were promoted to principal at Asabys Partners, reflecting increased responsibilities in deal sourcing and portfolio support.
Final Thoughts 📊
Regulatory action: 13 distinct approvals this week (9 FDA clearances or approvals, 3 CE Marks, 2 ISO certification).
Capital inflow: Publicly disclosed rounds, grants and warrant conversions total ≈127 million USD equivalent across eight currencies, with several Innovate UK grants and an undisclosed OSSTEC award on top.
Industry churn: 12 senior appointments signal continued talent rotation as scale-up pressure grows.
Innovation pulse: Remote neuro-thrombectomy over 1 600 km, a fully battery-free sacral neurostim, a silent low-field MRI and an eight-motor bionic hand—all in a single news cycle—underscore the breadth and speed of med-tech progress.