Senseonics brings one-year Eversense 365 CGM to Beta Bionics iLet platform
Senseonics and Beta Bionics plan to integrate Eversense 365 with iLet, pairing one-year implantable CGM with automated insulin delivery.
Medical Devices & Diagnostics
Medical Devices & Diagnostics
FDA 510(k) clearance gives CurveBeam AI first step toward CT bone-health SaaS
FDA clears CurveBeam AI’s BoneVue CT bone-density technology, while a second HiRise clearance remains necessary for its planned BMD SaaS launch.
Medical Devices & Diagnostics
FDA cleared Beta Bionics’ Mint patch pump. Why did BBNX immediately sell $150m of stock?
Beta Bionics wins FDA clearance for Mint, targets a Q1 2027 launch and prices a $150 million offering to support commercialization.
Medical Devices & Diagnostics
Telix Pharmaceuticals wins FDA approval for PIXCLARA glioma imaging
FDA approves Telix Pharmaceuticals’ PIXCLARA, the first FET-PET drug for differentiating glioma progression from treatment-related change.
Medical Devices & Diagnostics
Shoulder Innovations gets FDA clearance for titanium N-22 Humeral Head
Shoulder Innovations launches the FDA-cleared N-22 titanium humeral head, expanding shoulder replacement options for metal-sensitive patients.
Medical Devices & Diagnostics
Intus Biosciences gets $2.7m NCI award for microbiome-based early-onset colorectal cancer test
NCI awards Intus Bio $2.7 million to develop a microbiome-based test for early-onset colorectal cancer and precancerous lesions.
Medical Devices & Diagnostics
Helix launches Whole Exome+ diagnostic test for rare and unexplained genetic conditions
Helix launches Whole Exome+ combining exome, mitochondrial and chromosomal analysis for patients with rare and unexplained genetic conditions.
Medical Devices & Diagnostics
Can VERAFEYE replace multiple tools in the electrophysiology lab? LUMA Vision moves closer to launch
LUMA Vision expands FDA clearance for VERAFEYE, integrating cardiac imaging, 3D anatomy and catheter tracking ahead of its planned 2027 launch.
Medical Devices & Diagnostics
Acarix beat NT-proBNP on false positives, but can its acoustic heart test survive external validation?
Acarix heart failure algorithms showed strong sensitivity and fewer false positives than NT-proBNP, but larger external validation is still required.
Medical Devices & Diagnostics
CraniUS has cleared its first skull implant. The bigger NeuroPASS ambition is still investigational
FDA clears the patient-specific CraniUS Plate for cranial defect repair, giving CraniUS its first U.S. product while NeuroPASS remains investigational.