MolecuLight announced that it won FDA 510(k) clearance for its i:X handheld fluorescence imaging device for detecting wounds containing bacteria. MolecuLight i:X is designed to enable real-time point-of-care visualization of fluorescence in wounds, while it measures wounds and digitally records images and measurements. It received FDA de novo clearance in August 2018. The device’s fluorescence […]
FDA clearance positions Sight Diagnostics to deliver on two-drop blood testing promise
Today’s news that Sight Diagnostics secured 510(k) clearance for its Olo analyzer certainly will reduce the flow of future patient tears and fears as the system requires just two drops of blood to conduct a range of tests. However, the clearance — which confirms the Olo works just as well as gold-standard lab-grade systems in […]
Renovia lands FDA clearance for updated pelvic device
Renovia announced today that it won FDA 510(k) clearance for its next-generation Leva pelvic digital therapeutic for urinary incontinence (UI) in women. The Leva system is designed to strengthen pelvic floor muscles and treat stress incontinence as well as mixed and mild-to-moderate urgency UI in women. It uses Renovia’s patented movement-based sensor and app technology […]
FDA clears Life Spine Longbow titanium lateral expandable spacer system
Life Spine announced that it won FDA 510(k) clearance for its Longbow titanium lateral expendable spacer system. The Longbow system is the first interbody on the market that expands laterally in-situ, specifically for a direct lateral approach, according to Life Spine’s website. Longbow is designed to minimize tissue retraction and potential nerve damage associated with […]
OrthoPediatrics launches PediFoot system
OrthoPediatrics (NSDQ:KIDS) announced the U.S. launch of its PediFoot deformity correction system for feet after it won FDA 510(k) clearance months ago. The Warsaw, Ind.–based company picked up FDA approval in August for the PediFoot, which it said is the first pediatric-specific system for treating foot deformities. PediFoot utilizes plates and screws that are smaller than […]
BREAKING: FDA clears Pentax Medical duodenoscope meant to reduce superbug fears
The FDA today announced that it has cleared a duodenoscope from Hoya’s (TYO:7741) Pentax subsidiary that has a sterile, disposable elevator — a first in the U.S. The Pentax Medical duodenoscope’s design reduces the number of parts requiring cleaning and disinfection between uses, according to the FDA. Reducing reprocessing challenges, the thinking goes, will help prevent […]
Conformis launches next-generation hip system
Conformis (NSDQ:CFMS) has won FDA clearance for its latest 3D-designed Conformis hip system for hip surgeries. The Billerica, Mass.–based company began hip surgeries in July 2018 during a limited launch of its hip system. The latest version of the system, announced yesterday, incorporates design improvements based on surgeon feedback after more than 400 surgeries were completed […]
Vyaire Medical receives FDA clearance for Bellavista 1000e ventilator system
Vyaire Medical said today that it has won FDA 510(k) clearance for its Bellavista 1000e ventilator for the integration of high-flow oxygen therapy and advanced synchrony support. The Chicago-based company’s Bellavista 1000e ventilator is designed to improve the caregiver’s experience, offering a touch screen with advanced graphics to simplify the process of escalating care or […]
FDA clears DiFusion’s spinal implant with new biomaterial
DiFusion said today that it won FDA 510(k) clearance for its Xiphos-ZF spinal interbody device, the first spinal implant developed from the biomaterial Zfuze. Zfuze is a new biomaterial that is said to elicit pro-reparative M2 macrophage response and significant reductions in Interleukin 1-Beta and Interleukin 6. Both IL1-Beta and IL6 are cytokine markers for prolonged […]
FDA clears Stryker’s Sahara expandable interbody implant
Stryker (NYSE:SYK) said yesterday that it won FDA 510(k) clearance for its Sahara lateral 3D expandable interbody implant system. Sahara Lateral is the first ever 3D-printed lateral expandable fusion device, according to a news release. It is designed to allow surgeons up to 30 degrees of sagittal spinal correction in skeletally mature patients. The implant is […]
FDA clears HeartVista’s One Click AI-assisted cardiac MRI
HeartVista said today that it won FDA 510(k) clearance for its AI-assisted One Click MRI acquisition software for cardiac exams. The One Click system is designed to use AI-assisted software to prescribe the standard cardiac views with one click in as little as 10 seconds as the patient breathes freely. The system detects when images […]
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