Intuitive Surgical has submitted for FDA 510(k) clearance of its next-generation da Vinci 5 multiport surgical robot. The da Vinci 5 will join Intuitive’s existing da Vinci robotic surgical system portfolio alongside the multiport X and Xi systems and the single-port SP. There is also Ion, Intuitive’s robotic-assisted platform for minimally invasive biopsy in the […]
Food & Drug Administration (FDA)
FDA clears SnoreLessNow mandibular advancement device
SnoreLessNow announced today that the FDA granted 510(k) clearance for its over-the-counter dental device. Known as SomniFit-S in Europe, the Anti-Snore Mouth Guard+ reduces snoring by positioning the jaw gently forward. It allows for increased airflow and eliminates airway obstruction by tissues inside the mouth, requiring no masks, hoses or electronics. Swiss manufacturer Oscimed SA […]
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. Stentra is fabricated of bio-compatible nylon materials (nylon ISO 10993-1), using 3D SLS printing technology. Baltimore-based Kallisio says Stentra directs radiation to the target tumor area while reducing the harmful impact […]
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. LungQ 3.0.0 utilizes AI to automatically segment the pulmonary segments and subsegments in the internal anatomy of the lung. The analysis includes the identification of structures like lobes, segments, subsegments, airways and fissures. It analyzes the […]
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. ShortCut facilitates valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction. Rehovot, Israel–based Pi-Carda earned the breakthrough nod after completing enrollment in a U.S. and European pivotal study last September. The leaflet modification system […]
FDA approves expanded MRI labeling for Abbott Proclaim neurostim
Abbott announced today that the FDA approved expanded MRI labeling for its Proclaim DRG neurostimulation system. Proclaim DRG provides targeted relief for people with complex regional pain syndrome (CRPS) types I and II of the lower limbs. It stimulates the dorsal root ganglion (DRG) clusters of nerve cells found along the spine. Abbott says four […]
FDA warns on defective packaging with Exactech shoulder system
The FDA issued a warning related to possible health risks associated with the Exactech Equinoxe shoulder system joint replacement devices. Equinoxe devices replace painful shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or loss of normal structure and function. The devices also improve previously failed shoulder joint replacement devices with adequate bone and soft tissue […]
FDA clears stereotactic guidance system from ClearPoint Neuro
ClearPoint Neuro (Nasdaq:CLPT) announced today that it received FDA 510(k) clearance for its SmartFrame OR stereotactic system. Solana Beach, California–based ClearPoint Neuro developed its SmartFrame OR system with two main components. It features the SmartFrame OR technology with the ClearPointer optical navigation wand. SmartFrame OR offers stereotactic guidance for placing and operating instruments or devices […]
Fresenius Kabi has a Class I Ivenix infusion pump recall
The FDA determined that a recall of the Fresenius Kabi Ivenix large-volume infusion pump is Class I, the most serious kind. This recall affects the LVP-0004 model of the Ivenix large-volume pumps. Fresenius Kabi distributed these systems between Oct. 1, 2021, and July 31, 2023. In total, the company recalled 938 devices in the U.S. […]
ResMed CPAP masks recall is Class I
The FDA announced that ResMed’s voluntary recall of millions of CPAP mask magnets is now Class I, the agency’s most serious level. Last month, ResMed warned CPAP users about potential magnetic interference when magnets go near certain implants and medical devices in the body. People using CPAP masks with magnets only need to return […]
Zeta Surgical wins expanded FDA nod for mixed reality navigation system
Zeta Surgical announced today that the FDA granted it a special 510(k) clearance for expanded software functionality. The Zeta cranial navigation system’s special clearance applies to enhanced software features and compatibility with additional accessories. Zeta Surgical’s mixed reality (MR) system initially received FDA clearance in September. The Zeta cranial navigation system provides surgeons with GPS-like […]