Why Zepto Life Technology’s FDA breakthrough status matters for infectious disease diagnostics
Zepto’s FungiFlex brings liquid biopsy to invasive mold infections. The FDA designation tests whether faster fungal diagnosis can change care.
Medical Devices & Diagnostics
Medical Devices & Diagnostics
FDA breakthrough status gives Coredio’s AI heart failure platform a faster regulatory path
Coredio’s AI heart failure platform may bring hemodynamic insight into home care. See why FDA breakthrough status matters now.
Medical Devices & Diagnostics
Is Avvio Medical building the next outpatient frontier in kidney stone and ureteral stone therapy?
Ureteral stones need faster care. Avvio Medical’s outpatient device tests whether microbubble lithotripsy can ease OR bottlenecks.
Medical Devices & Diagnostics
Valar Labs FDA breakthrough nod signals new test for AI-led bladder cancer risk prediction
Bladder cancer risk tools leave gray zones. Valar Labs’ FDA breakthrough nod tests whether AI pathology can narrow them.
Medical Devices & Diagnostics
Why PreludeDx’s second FDA breakthrough device designation matters for precision diagnostics
Breast cancer care needs sharper radiation decisions. PreludeDx’s AidaBREAST now faces the harder test of validation, adoption and access.
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 Sonorous Neurovascular’s BosCATH FDA clearance could matter more than it first appears
Find out how Sonorous Neurovascular’s BosCATH FDA clearance strengthens its neurovascular access strategy today!
Medical Devices & Diagnostics
What Spear Bio’s new pTau 217 assay reveals about where Alzheimer’s biomarker detection is heading
Spear Bio debuts BD-pTau 217, alpha-synuclein and pS129-a-syn assays at AD/PD 2026. What the claims mean for Alzheimer's and Parkinson's research. Read the analysis.
Medical Devices & Diagnostics
Why Airiver Medical’s paclitaxel drug coated balloon could reshape minimally invasive airway treatment
Airiver Medical wins FDA Breakthrough Device status for its pulmonary drug coated balloon. Discover what this means for airway stenosis treatment and clinical trials.
Medical Devices & Diagnostics
Instanosis secures FDA breakthrough status for xylazine urine test as overdose care faces new diagnostic gaps
Instanosis wins FDA breakthrough status for its xylazine urine test. Find out why this matters for overdose diagnostics and what challenges remain.