Weekly MedTech Round-up - Week 27, 2025
Curated by GS Capital Connect & Guided Solutions research desk. Sources include company press releases, regulatory databases, and investor updates. Ideal for innovators, strategics, and investors tracking what matters most in medical technology.
1 | Leadership & Boardroom Shifts
Danaher has promoted Martin Stumpe, PhD to Chief Technology & AI Officer. Stumpe, a deep-learning pioneer (ex-Grail, Google), is charged with threading diagnostic-grade AI through Danaher’s life-science and clinical platforms so instruments deliver answers, not just data.
Saluda Medical will hand the CEO reins to Barry Regan on 14 July. After scaling Dexcom’s global ops, Regan is expected to drive rapid adoption of Saluda’s Evoke® ECAP-guided SCS in the U.S. and EU.
Zynex installs Steven Dyson as CEO on 18 August, betting his payer-network pedigree will widen reimbursement for Zynex’s NMES & pain-control wearables while founder Thomas Sandgaard becomes executive chair.
Cellese welcomes Erica Jordan to steer the AnteAGE® regenerative-skin franchise deeper into professional clinics and APAC retail.
Avivomed brings in neuromodulation veteran Dan Brounstein to shepherd its minimally invasive hypoglossal-nerve stimulator for obstructive sleep apnoea toward first-in-human studies.
Medtronic appoints Michelle Quinn (ex-BD) as General Counsel—an unmistakable nod to more tuck-in M&A and partnership deals.
Vicarious Surgical beefs up its board with finance leaders Fuad Ahmad and Joseph Doherty as it edges toward FDA clearance of its humanoid single-port robot.
Pylon Medical adds stroke authority Dr Elad Levy to its Medical Advisory Board, sharpening clinical strategy for the first direct-carotid access platform.
2 | Regulatory & Market Access
SonoClear landed FDA Breakthrough Device status for its hydrophilic membrane that clears blood and bone dust from the ultrasound window during cranial surgery—fast-tracking review and future CMS coverage.
Glaukos secured EU-MDR certification for iStent Infinite® and iStent Inject W®, unlocking broader European use of micro-invasive glaucoma surgery.
Intuitive Surgical won the CE Mark for da Vinci 5; European surgeons now get lighter arms, 3-D 4K vision and an AI-ready data backbone.
Methinks AI gained FDA 510(k) for its non-contrast CT stroke software that spots LVOs in minutes—even where perfusion CT is unavailable.
Fasikl earned FDA 510(k) for the Felix NeuroAI™ wristband, which senses tremor frequency and returns personalised peripheral-nerve stimulation in real time.
Dozee achieved an EU CE Mark for its under-mattress radar sensor, turning any bed into a contact-free vitals monitor for “virtual step-down” care.
Neurent Medical secured national Cigna reimbursement for Neuromark®, giving chronic-rhinitis patients a covered 10-minute office procedure.
3 | Funding & Investment
Kardium raised $250 million to triple production of its Globe® single-balloon PFA catheter and run a U.S. IDE head-to-head with thermal ablation.
Field Medical closed a $35 million Series B to launch a pivotal VT trial for FieldForce™, the first focal PFA platform built for thick ventricular muscle.
CroíValve won €12.5 million (grant + equity) from the EU EIC Accelerator to expand trials of its DUO™ tricuspid coaptation implant.
Escala Medical secured €4.5 million to commercialise Mendit™, a 15-minute suturing-free repair for pelvic-organ prolapse.
CalmWave added $4.4 million after showing a 90 % drop in non-actionable ICU alarms; proceeds fund wider “Transparent AI” deployments.
OutSee picked up £1.8 million seed to expand its AI-designed disordered-protein therapeutics pipeline beyond oncology.
4 | Clinical Milestones
Foldax reported zero structural deterioration at one year for its Tria™ polymer mitral valve, hinting at an anticoag-free future for younger patients.
InterShunt treated the first HFpEF patient in EASE-HF2; its device creates a calibrated LA-to-RA shunt to offload pressure during exertion.
MiRus showcased early-feasibility success with its 8-F sapphire-coated Siegel TAVR delivery system—vital for small vessels and Asian markets.
HeartBeam met pivotal endpoints: a chest patch plus cloud AI reconstructed diagnostic 12-lead ECGs outside hospital walls.
FineHeart received Slovenian approval to begin first-in-human implants of FlowMaker®, a 120-gram fully implantable LVAD synchronised to native rhythm.
Phagenyx hit 400 enrolments in the PhEAST RCT, testing pharyngeal electrical stimulation to restore swallowing post-stroke.
5 | Deals & Alliances
Teleflex finalised its €760 million purchase of Biotronik’s Vascular Intervention unit, doubling its cath-lab footprint and adding drug-coated balloons.
Stille AB is acquiring UK-based Surgical Holdings, marrying Swedish precision instruments with an NHS repair hub.
HealthpointCapital snapped up ImmersiveTouch to bring XR surgical-planning into its MSK implant ecosystem.
Acutus Medical will sell its AcQMap business to China’s EnChannel Medical, pivoting to subscription-based cardiac diagnostics.
Philips and Medtronic forged a multi-year pact to funnel Philips bedside-monitor data into Medtronic’s AI risk-stratification engine.
6 | Innovation & Launches
CIRCA Scientific completed limited release of CrossWise RF, a wire-free trans-septal system that shaves 10 minutes off every PVI and lowers embolic risk.
Moon Surgical secured a fourth FDA clearance for Maestro™, enabling OR-wide connectivity and a PCCP roadmap for autonomous ScoPilot™ updates.
Lifecare ASA cleared EMC testing of its rice-grain CGM implant, proving resilience to 5 G and MRI interference ahead of first-in-human trials.
Getinge launched a neonatal module for the Servo-c ventilator, accurately delivering tidal volumes below 2 mL for preemies under 1 kg.
Final Take
Week 27 highlighted an industry racing toward smaller devices, smarter software and faster paths to payment. Pulsed-field ablation is redefining electrophysiology; AI is embedding itself from robotics to wearables; and reimbursement wins (Neuromark, Dozee) remind us that payment pathways—not shiny tech—ultimately dictate adoption curves.
On the radar for Week 28:
Rumblings of a Q3 IPO from a digital pathology player
First U.S. implants of FlowMaker® LVAD
FDA draft guidance on adaptive AI algorithms
Questions or news to share? Drop me a note. See you next Saturday. 🚀
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