MedTech News
Able Medical Announces 510(k) Clearance of New RIB System Indicated for Thoracic Repair
The single-use, PEEK-based RIB System utilizes the platform technology of Able’s Valkyrie® Thoracic Fixation System, further strengthening Able Medical’s portfolio.
CroíValve wins FDA IDE for tricuspid heart valve
CroíValve announced today that it began an early feasibility study for its Duo tricuspid coaptation valve system.
Abbott wins FDA nod for world’s smallest rechargeable DBS system with remote programming
Abbott (NYSE: ABT)+
announced today that it received approval from the FDA for the launch of its Liberta RC DBS system
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.