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Infographic showing Laplace Interventional’s TRIUMPH pivotal trial, highlighting treatment of the first three patients, the FDA-authorised randomised study design, and plans to enrol about 400 patients for its investigational tricuspid valve.
Medical Devices & Diagnostics

Laplace Interventional is taking on an approved tricuspid valve with TRIUMPH, but can its new implant deliver better outcomes?

Laplace Interventional has treated the first three patients in its FDA-authorised TRIUMPH pivotal trial, moving its investigational tricuspid valve into a randomised comparison with commercial replacement technology. With approximately 400 patients planned for the main study, the company must demonstrate meaningful safety and effectiveness in an increasingly competitive structural heart market.

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Representative image of babesiosis research and tick-borne infection testing as 60 Degrees Pharmaceuticals reports promising parasite clearance results in patients with relapsing babesiosis treated with tafenoquine-based combination therapy.
Pharma & Biotech

Tafenoquine combinations show promising parasite clearance in immunocompromised patients with babesiosis

60 Degrees Pharmaceuticals reports negative Babesia PCR tests in five patients receiving tafenoquine combinations, with FDA discussions planned.

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Pheast Therapeutics’ PHST001 anti-CD24 research highlights a macrophage-directed approach to targeting solid tumors as Phase 1 combination testing advances. Representative image.
Pharma & Biotech

Moffitt Cancer Center advances Anixa ovarian CAR-T trial without dose-limiting toxicity

Anixa's ovarian cancer CAR-T inventor will deliver a November keynote as lira-cel advances through Phase 1 dose escalation. Preliminary findings include four patients surviving more than one year and an initial 90-day stable disease observation, but controlled efficacy evidence is not yet available.

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Aqua Medical’s RESTORE-1 IDE study is evaluating whether radiofrequency vapor ablation of proximal intestinal mucosa can improve HbA1c, with the second US patient now treated in the 20-participant trial. Representative image.
Medical Devices & Diagnostics

Can resurfacing the small intestine improve type 2 diabetes? Aqua Medical’s US IDE study starts testing the idea

Aqua Medical has treated the second US patient in RESTORE-1, a 20-person IDE study evaluating whether RF vapor ablation of proximal intestinal mucosa can improve HbA1c.

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Mezzion’s investigational drug udenafil has reduced kidney cyst burden in an ADPKD animal study, strengthening the scientific rationale for the company’s planned Phase 2b clinical programme. Representative image.
Pharma & Biotech

Mezzion’s new kidney disease data sent shares higher, but the decisive test is still ahead

Mezzion reports animal-model ADPKD data for udenafil as it prepares Phase 2b testing. The findings support development, but human efficacy is unproven.

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Robotic endoscopic surgery in a modern hospital setting illustrates EndoQuest Robotics’ PARADIGM trial milestone, as the company advances its investigational Endoluminal Surgical System toward a planned United States Food and Drug Administration De Novo submission. Representative image.
Medical Devices & Diagnostics

EndoQuest’s ELS robot posted striking early resection results. What will the FDA demand next?

EndoQuest completes PARADIGM enrollment with encouraging preliminary ESD results, setting up a critical FDA De Novo submission.

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Representative image of a patient using a connected glucose monitor while a clinician reviews AI-supported insulin-management data through a secure digital-care platform.
Medical Devices & Diagnostics

How UpDoc’s clinical AI could transform insulin management without replacing physicians

UpDoc is moving patient-facing artificial intelligence beyond reminders and administrative support into insulin management. Its narrow FDA clearance, physician-defined limits and early clinical evidence reveal both the potential and the boundaries of autonomous chronic-disease care.

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Representative image: Syntax Bio’s expanded Series A funding highlights growing investor interest in Cellgorithm-driven stem cell therapy for type 1 diabetes.
Pharma & Biotech

Syntax Bio funding boost puts pancreatic beta cell therapy closer to preclinical test

Find out how Syntax Bio’s expanded Series A could shape Cellgorithm-based beta cell therapy for type 1 diabetes.

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Pharma & Biotech

Why Pendulum Therapeutics is taking its microbiome platform beyond metabolic health with Mayo Clinic

Pendulum Therapeutics has expanded its Mayo Clinic collaboration into women’s health and dermatology. Read what this could mean for microbiome medicine.

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Representative image of an electrocardiogram-based artificial intelligence workflow highlighting the broader clinical relevance of Anumana’s FDA-cleared ECG-AI algorithm for early pulmonary hypertension detection.
Medical Devices & Diagnostics

What Anumana’s FDA-cleared pulmonary hypertension algorithm means for cardiovascular AI

Anumana won FDA clearance for an ECG-AI pulmonary hypertension tool. Read what it changes for diagnosis, workflow adoption, and cardiovascular AI strategy.

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