Can Chest Wall Innovations turn FDA clearance into adoption in rib fixation?
Rib fixation is gaining clinical ground. Chest Wall Innovations now faces the harder test: converting FDA clearance into surgeon adoption.
Medical Devices & Diagnostics
Medical Devices & Diagnostics
Can Earflo reduce ear tube surgery pressure with its FDA-cleared pediatric device?
Pediatric ear care has long had a waiting-room problem. Earflo’s FDA-cleared device tests whether home therapy can close the gap.
Medical Devices & Diagnostics
Why Gemelli Biotech’s 3-gas breath test could reshape how clinicians evaluate SIBO
Gut diagnostics need proof, not buzz. Gemelli Biotech’s DDW 2026 visibility could test whether IBS and SIBO care is ready for precision tools.
Medical Devices & Diagnostics
Pharma & Biotech
Merck KGaA just made a quiet digital-health move. Could hybrid drugs be pharma’s next big reset?
Digital therapeutics struggled alone. Remepy and Merck KGaA are testing whether software works better when built into the drug itself.
Medical Devices & Diagnostics
Why the FDA breakthrough pathway matters for Laguna Diagnostics’ psychiatric test
Psychiatry needs objective diagnostics. Laguna Diagnostics now faces the harder test: proving mRNA biomarkers can scale in real care.
Medical Devices & Diagnostics
Why Abbott’s Ultreon 3.0 could reshape stent planning in complex coronary disease
AI can now guide coronary imaging in real time. Abbott’s Ultreon 3.0 puts precision PCI closer to routine clinical workflow.
Medical Devices & Diagnostics
Can Lasix ONYU move heart failure edema care from hospital infusion to home treatment?
Heart failure care needs fewer hospital stays. Lasix ONYU now tests whether Europe is ready for at-home subcutaneous diuresis.
Medical Devices & Diagnostics
TytoCare just opened a new FDA category. Can AI make home ear exams clinically useful?
Home diagnostics need regulatory trust. TytoCare’s FDA De Novo win tests whether AI can move ear exams beyond video visits.
Medical Devices & Diagnostics
Why Pulse Biosciences’ 12-month nsPFA data matters in a PFA market dominated by Farapulse and Affera
Boston Scientific owns the PFA market. Pulse Biosciences just posted 90% one-year AF freedom. Is nanosecond PFA a real disruption or an acquisition target?
Medical Devices & Diagnostics
Adagio Medical reports pivotal FULCRUM-VT results as FDA pathway sharpens for vCLAS ablation system
VT ablation remains difficult. Adagio Medical’s pivotal vCLAS data now shifts the question from feasibility to FDA and clinical adoption.