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 […]
Implants
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 […]
Medtronic reports promising early data for transfemoral delivery of its Intrepid TMVR
Medtronic (NYSE:MDT) this week touted data for its Intrepid self-expanding transcatheter mitral valve replacement (TMVR) system. Early data from 15 patients in an early feasibility study was presented as late-breaking clinical science at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation. The study evaluated patients with severe, symptomatic […]
Ocular Therapeutix claims win as court invalidates drug delivery patent from Mati
Ocular Therapeutix (NSDQ:OCUL) announced today that an appeals court invalidated a drug delivery system patent held by Mati Therapeutics. The U.S. Court of Appeals for the Federal Circuit in Washington, D.C., invalidated the patent related to a drug delivery system containing dexamethasone, affirming the judgment made in June 2020 by the Patent Trial and Appeal Board […]
Alcon to acquire Ivantis for $475M
Alcon (NYSE:ALC) announced today that it intends to acquire glaucoma surgery device maker Ivantis for $475 million upfront. Geneva, Switzerland-based Alcon aims to bolster its portfolio across cataract, refractive, retina and glaucoma offerings by acquiring Ivantis and its novel Hydrus Microstent for minimally invasive glaucoma surgery (MIGS). Ivantis designed the Hydrus Microstent to lower intraocular […]
CVRx rises on Street-beating Q3
CVRx (NSDQ:CVRX) shares ticked up today on third-quarter results that came in ahead of the consensus forecast. The Minneapolis-based implantable neuromodulation technology developer posted losses of $6.1 million, or 30¢ per share, on sales of $3.4 million for the three months ended Sept. 30, 2021, for a nearly doubled bottom-line slide deeper into the red […]
Staar Surgical beats the Street in Q3, reports order backlog of more than 20,000 lenses
Staar Surgical (NSDQ:STAA) posted third-quarter results after markets closed yesterday that beat the consensus forecast on Wall Street and raised its outlook for the rest of the year. The Lake Forest, California-based implantable lens maker reported profits of $6.0 million, or $0.12 per diluted share, on sales of $58.4 million for the three months ended […]
Stryker stock slips on Q3 earnings miss, full-year guidance downgrade
Shares of Stryker (NYSE:SYK) stock slipped today after the company downgraded its full-year outlook and announced third-quarter operating results that missed Wall Street’s expectations. The Kalamazoo, Michigan–based orthopedic device maker posted profits of $438 million, or $1.17 per diluted share, on sales of $4.16 billion for the three months ended Sept. 30, 2021, resulting in […]
FDA approves Genentech’s Susvimo drug-eluting eye implant
Genentech announced today that it received FDA approval for its Susvimo injection for treating macular degeneration (AMD). South San Francisco-based Genentech, a member of the Roche Group, designed its Susvimo ranibizumab injection (100 mg/mL) for intravitreal use via ocular implant for treating people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to […]