MedTech News
.................... by Andrew Celentano
FDA clears Syngo Virtual Cockpit tech from Siemens Healthineers
Siemens Healthineers announced that the FDA cleared its Syngo Virtual Cockpit, a private, secure communication platform.
Intuitive wins CE mark for da Vinci SP surgical robot
Intuitive Surgical (Nasdaq: ISRG)+
announced today that it received CE mark approval for its da Vinci SP surgical robot platform.
Sequana Medical announces DSMB approval to start randomized MOJAVE cohort – US Phase 1/2a study of DSR® 2.0 for treatment of heart failure
DSMBi rates DSR 2.0 as safe following review of data from non-randomized cohort
Data from non-randomized cohort confirms dramatic improvement in diuretic response and at least 95% reduction in loop diuretic requirements up to almost four months after last DSR therapy
First patient enrolled in randomized controlled cohort expected in Q1 2024
FDA clears SnoreLessNow mandibular advancement device
SnoreLessNow announced today that the FDA granted 510(k) clearance for its over-the-counter dental device.
FDA clears Kallisio’s 3D-printed oral insert for radiation therapy
Kallisio recently announced that the FDA has cleared its 3D-printed Stentra, used to protect head and neck cancer patient’s healthy tissue during radiation therapy.
FDA clears AI-based lung analysis software from Thirona
Thirona announced today that it received FDA 510(k) clearance for the latest update of its AI-based LunQ clinical software.
FDA grants breakthrough nod for Pi-Cardia leaflet modification device for TAVR
Pi-Cardia announced today that the FDA granted breakthrough device designation for its ShortCut leaflet modification device.
New cause of neuron death in Alzheimer’s discovered
Short, toxic RNAs kill brain cells and may allow Alzheimer’s to develop