Envista (NYSE:NVST) announced today that the FDA cleared the Nobel Biocare N1 implant system of instruments, prosthetic components and surgical protocols. The N1 system includes an implant designed for immediate placement and predictable insertion torques, providing a trioval conical connection for the abutment to slide into place. Additionally, the system has an emergence profile designed […]
Implants
Fuse Medical inks U.S. distro deal with BRM Extremities for Silktoe arthroplasty implant
Fuse Medical announced today that it entered into a distribution partnership with BRM Extremities for the U.S. distribution of Silktoe. Richardson, Texas-based Fuse inked the deal for the exclusive U.S. distribution of the Silktoe metatarsophalangeal joint arthroplasty implant, adding to the company’s portfolio of lower extremity products. BRM designed Silktoe as a solution for patients […]
FDA advisory votes against BrainsGate’s neurostim device for treating stroke
At the end of last week, an FDA advisory panel voted down BrainsGate’s neurostimulation device for treating stroke. BrainsGate designed its technology as a five-minute procedure. A neurostimulator implant is injected into an existing canal to stimulate a nerve center and augment collateral blood flow, improving stroke patients’ outcomes within a 24-hour window. The platform […]
Ocular Therapeutix touts positive trial results of ophthalmic insert for dry eye disease
Ocular Therapeutix (NSDQ:OCUL) announced today that it reported positive results from a Phase 2 trial of its dry eye disease treatment. Bedford, Massachusetts-based Ocular Therapeutix’s U.S.-based Phase 2 clinical trial evaluated OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of dry eye disease. Get the full story at our sister site, Drug Delivery Business News.
FDA clears CoreLink’s CentraFix midline fixation system
CoreLink announced today that it won FDA 510(k) clearance for and commercially launched its CentraFix midline fixation system. St. Louis-based CoreLink designed CentraFix as a posterior thoracolumbar pedicle screw for less invasive spinal fixation, often used with a medial-to-lateral approach known as cortical bone trajectory (CBT). According to a news release, that technique allows for […]
Miach Orthopaedics makes ACL tear implant commercially available in U.S.
Miach Orthopaedics announced today that it made the BEAR implant for treating anterior cruciate ligament (ACL) tears commercially available in the U.S. Westborough, Massachusetts–based Miach designed the BEAR (Bridge-Enhanced ACL Restoration) implant to enable the healing of a patient’s torn ACL, shifting from the current standard of care that includes reconstruction that replaces the ACL […]
FDA grants IDE nod to LensGen’s presbyopia-correcting intraocular lens
Intraocular lens developer LensGen announced today that it received FDA investigational device exemption (IDE) for its Juvene lens. Irvine, California-based LensGen designed the Juvene intraocular lens (IOL) for patients with cataracts, with the IDE set to initiate a pivotal study for the device. The company developed Juvene IOL t0 permanently restore clear and continuous vision at […]
FDA grants breakthrough device designation for Theradaptive’s spinal fusion implant
Theradaptive announced today that it received FDA breakthrough device designation for its Osteo-Adapt SP spinal fusion implant. Frederick, Maryland–based Theradaptive designed the Osteo Adapt SP implant for transforaminal lumbar interbody spinal fusion to treat degenerative disc disease, spondylolisthesis or retrolisthesis. According to a news release, the company touts its regenerative implants as best-in-class with designs […]
FDA grants breakthrough nod to Blackrock Neurotech’s brain-computer interface
Blackrock Neurotech announced that it received FDA breakthrough device designation for its MoveAgain brain-computer interface (BCI) system. Salt Lake City-based Blackrock Neurotech designed its MoveAgain BCI system to provide immobile patients the ability to control a mouse cursor, keyboard, mobile device/tablet, wheelchair or prosthetic device by only thinking, according to a news release. The company […]
Abbott reports positive trial results for new leadless pacemaker
Abbott (NYSE:ABT) recently announced that its Aveir leadless pacemaker could offer new benefits in treating slow heart rhythms. Late-breaking data from the global Leadless II FDA investigational device exemption (IDE) study — announced last week — showed that Aveir met pre-specified primary endpoints in patients with certain abnormal heart rhythms. Abbott said the results suggested […]
Zimmer Biomet’s plan to be the ‘boldest’ company in medtech
Ivan Tornos wants to transform Zimmer Biomet (NYSE: ZBH) into a fast-moving firm that better leverages tech in orthopedics. DeviceTalks Editorial Director Tom Salemi spoke with Tornos, chief operating officer of Zimmer Biomet, about the company’s broad technology offerings including its ZBEdge, Persona IQ smart knee implant and other digital data collectors. Tornos joined the […]