Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance and breakthrough device designation for its LigaPASS 2.0. According to a news release, LigaPass is the first and only FDA-cleared device with an indication for ligament augmentation in spine surgery. The company designed the LigaPASS 2.0 ligament augmentation system due to its positive impact on […]
510(k)
Outset Medical stock down on shipment hold news
Outset Medical (Nasdaq: OM) stock lost about a third of its value today — a day after the company said it was holding shipments of its Tablo hemodialysis system for home use. OM shares were down more than 34% to $13.46 apiece by the close of trading today. MassDevice‘s MedTech 100 Index, which includes stocks of […]
FDA clears Ekso Bionics’ robotic exoskeleton for use with MS patients
Ekso Bionics (Nasdaq:EKSO) announced today that it received FDA 510(k) clearance for its EksoNR robotic exoskeleton. Richmond, California–based Ekso Bionics designed the EksoNR technology for use with Multiple Sclerosis (MS) patients. According to a news release, EksoNR is the first exoskeleton device to receive FDA clearance for rehabilitation use in patients with MS, significantly expanding […]
Si-Bone wins FDA clearance for expanded iFuse-TORQ implant indication
Si-Bone announced today that the FDA granted clearance for its iFuse-TORQ implant for pelvic fracture fixation. The regulatory nod expands Si-Bone’s iFuse-TORQ’s indication for acute, non-acute and non-traumatic pelvic fractures, including pelvic fragility fractures (fractures related to low-energy traumatic events) and pelvic insufficiency fractures. Santa Clara, California-based Si-Bone said in a news release that the […]
FDA clears Lensar Ally cataract treatment system
Lensar (Nasdaq:LNSR) announced today that it received FDA 510(k) clearance for its next-generation Ally system. Orlando, Florida–based Lensar designed the Ally adaptive cataract treatment system to enable cataract surgeons to complete the femtosecond-laser-assisted cataract (FLACS) procedure seamlessly in a single, sterile environment. According to a news release, the company intends to deliver the first Ally […]
FDA clears lumbar interbody fusion device from Zavation Medical
Zavation Medical announced today that it received FDA 510(k) clearance for its eZspand lateral expandable lumbar interbody fusion device. Flowood, Mississippi-based Zavation designed the eZspand lateral, part of the Zavation eZspand interbody system, with precision and continual expansion to offer an optimized fit for each patient, allowing for the enhancement of structural stability and improved […]
AI-powered scope developer says new FDA clearance opens the door for telehematology
Scopio Labs today announced FDA 510(k) clearance for its X100HT, which features a new slide loader that automatically prepares samples and feeds them into the digital blood scanner for AI-powered analysis. The Tel Aviv-based digital microscope developer said the technology eliminates the need for manual microscopic examination when reviewing white and red blood cells and […]
Cardio Flow’s FreedomFlow guidewire wins FDA clearance
Cardio Flow this week won FDA 510(k) clearance for its FreedomFlow peripheral guidewire and announced the first commercial case using the device in the U.S. St. Paul, Minnesota-based Cardio Flow designed FreedomFlow to provide support for diagnostic and therapeutic devices in treating plaque blockages in arteries above and below the knee. It has a stainless […]
FDA clears integration of Medtronic’s monitoring platforms with GE Healthcare’s Carescape
Medtronic’s (NYSE:MDT) Microstream capnography (CO2) and Invos regional oximetry (rSO2) platforms can now be integrated with GE Healthcare’s Carescape. The two companies announced today that they received FDA clearance and CE mark approval for the integration of Medtronic’s Microstream and Invos technologies for perioperative and ICU care on the GE Healthcare Carescape precision monitoring platform. According […]
Stryker’s spine guidance software wins FDA clearance
Stryker (NYSE:SYK) announced today that its Q Guidance System for advanced surgery planning received FDA 510(k) clearance. Kalamazoo, Michigan–based Stryker designed the Q Guidance system for use with its spine guidance software for advanced planning and intraoperative guidance that enables open or percutaneous computer-assisted surgery. Q Guidance offers multiple tracking options, sophisticated software algorithms and […]
Si-Bone wins FDA clearance for pelvic fixation, fusion tech
Si-Bone announced today that it received FDA 510(k) clearance for its iFuse Bedrock Granite implant system for spinal procedures. Santa Clara, California-based Si-Bone designed the iFuse “Granite” implant to provide sacroiliac fusion and sacropelvic fixation as a foundational element for segmental spinal fusion. According to a news release, FDA clearance follows earlier breakthrough device designation […]
