InnovHeart performs first U.S. Saturn transseptal mitral valve replacement
InnovHeart has implanted its investigational Saturn transseptal mitral valve in the first U.S. patient as the CASSINI program reaches 15 treated patients globally.
Medical Devices & Diagnostics
Medical Devices & Diagnostics
Mainstay ReActiv8 sustains chronic low back pain gains through two years in RESTORE trial
Two-year RESTORE results show sustained disability, pain and quality-of-life improvements with Mainstay Medical’s ReActiv8 restorative neurostimulation system for chronic low back pain.
Medical Devices & Diagnostics
WHO lists Cepheid Xpert Hemorrhagic Fever Panel for Ebola response in Democratic Republic of the Congo
The WHO has granted Emergency Use Listing to Cepheid’s one-hour Xpert Hemorrhagic Fever Panel for the Ebola Bundibugyo outbreak in the DRC, enabling use on existing GeneXpert systems.
Medical Devices & Diagnostics
One cardiac MRI can take an hour to measure manually. Heartvue has FDA clearance to automate much of that work
Heartvue.ai has received FDA 510(k) clearance for Heartvue.Proton, machine-learning software that automates key cardiac MRI measurements and includes an authorized Predetermined Change Control Plan.
Medical Devices & Diagnostics
Nyxoah Genio hits both pivotal endpoints in sleep apnea patients excluded from current U.S. neurostimulation
Nyxoah’s ACCCESS pivotal study produced a 77.2% AHI responder rate and 87.7% oxygen-desaturation responder rate with no device-related serious adverse events through 12 months.
Medical Devices & Diagnostics
Bayesian Health sepsis AI wins Medicare NTAP reimbursement starting October 2026
CMS has approved a New Technology Add-on Payment for Bayesian Health’s FDA-cleared continuous sepsis flagging software, creating an additional Medicare reimbursement pathway for eligible inpatient use beginning October 1.
Medical Devices & Diagnostics
FDA clears Hamamatsu NanoZoomer S20MD and S540MD as digital pathology competition expands
Hamamatsu has announced U.S. FDA 510(k) clearances for the NanoZoomer S20MD and S540MD whole-slide imaging systems, extending its regulated digital pathology portfolio from compact benchtop use to high-throughput laboratories.
Medical Devices & Diagnostics
Norroy starts 600-patient Phase 3 trial of 177Lu-NYM032 in metastatic prostate cancer
Norroy Bioscience has started pivotal Phase 3 development of 177Lu-NYM032 in PSMA-positive metastatic castration-resistant prostate cancer, with a registered target enrollment of about 600 patients and overall survival as the primary objective.
Medical Devices & Diagnostics
Stryker performs first Apple Vision Pro hip surgery using FDA-authorized SportSuite Vision
Stryker has completed the first hip arthroscopy using SportSuite Vision on Apple Vision Pro after securing FDA De Novo authorization for the spatial-computing surgical application.
Medical Devices & Diagnostics
BillionToOne launches Northstar Origin liquid biopsy to predict where an unknown cancer began
BillionToOne has launched Northstar Origin, a laboratory-developed liquid biopsy add-on that combines cfDNA methylation and genomic signals to predict tumor tissue of origin from one blood sample.