RTI Surgical (NSDQ:RTIX) shares dipped today on first-quarter results that fell short of the consensus forecast. The Deerfield, Ill.-based company posted losses of -$17.9 million, or -24¢ per share, on sales of $73.7 million for the three months ended March 31, 2020, for a 91% bottom-line slide on sales growth of 5.3%. Adjusted to exclude one-time […]
CoreLink wins FDA clearance for standalone cervical spine system
CoreLink announced today that it received FDA 510(k) clearance for its F3D-C2 standalone cervical system for ACDF procedures. The F3D-C2 standalone cervical device eliminates the need for a supplemental fixation plate to make ACDF (anterior cervical discectomy and fusion) procedures easier to complete and a faster process overall. St. Louis-based CoreLink’s system includes its 3D-printed […]
Pantheon Surgical acquires sacroiliac screw system
Pantheon Surgical recently announced its acquisition of the Topaz/Compressive sacroiliac screw system. Pantheon Surgical acquired the technology from Osseus Fusion Systems, which will continue to distribute the Blue Topaz/Compressive system. Financial terms of the deal were undisclosed. “I’m excited about the transfer acquisition of the Blue Topaz/Compressive system into the Pantheon armamentarium. I look forward […]
FDA clears Orthofix Firebird SI fusion system
Orthofix (NSDQ:OFIX) announced today that it received FDA 501(k) clearance for its Firebird SI 3D-printed titanium bone screw. Lewisville, Texas-based Orthofix touts its Firebird SI as the first 3D-printed titanium bone screw to launch in the U.S. for treating sacroiliac (SI) joint dysfunction. The fusion system is designed to both compress and stabilize the SI joint, […]
FDA approves Mainstay Medical neurostim device
Mainstay Medical announced that it received FDA premarket approval for its ReActiv8 implantable neurostimulation system for chronic low back pain. ReActiv8 treats intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy and are not candidates for spine surgery, according to a […]
NuVasive launches pediatric spinal deformity device
NuVasive (NSDQ:NUVA) announced today that it launched its Reline 3D posterior fixation system for pediatric spinal deformities. San Diego-based NuVasive’s latest addition to its spine portfolio is now commercially available around the globe for treating adolescent idiopathic scoliosis (AIS). The Reline 3D is designed to turn a multi-step technique into a holistic, single-plane correction to offer […]
CEO Kevin Lobo says Stryker ready to regain lost momentum
Stryker (NYSE:SYK) CEO Kevin Lobo said today that the company is preparing to restart “a number” of idled production lines next month as it climbs out the crater created by COVID-19. In an interview on the DeviceTalks Weekly Podcast, Lobo said the company is rebounding from its low point in April, when its sales fell almost […]
Support grows for return of medtech reps to hospitals
Twenty-six more medical and surgical societies and healthcare associations have endorsed guidelines for the safe return of medtech company representatives to healthcare facilities during the coronavirus pandemic. The guidance, released in May by AdvaMed, the Association of periOperative Registered Nurses (AORN) and the American Hospital Association (AHA), builds on the April 17 joint statement by AHA, […]
Nuvasive announces $400m offering
NuVasive (NSDQ:NUVA) announced that it intends to offer $400 million aggregate principal amount of convertible senior notes in a private offering. The San Diego-based spine technology company is offering the notes, due in 2023, as well as granting initial purchasers a 13-day option to purchase up to an additional $50 million in notes. According to a […]
NuVasive lands 2 510(k)s, launches spinal surgery device
NuVasive (NSDQ:NUVA) announced that it received FDA 510(k) clearance for its Modulus ALIF and Cohere TLIF-O offerings for thoracolumbar procedures. The San Diego-based company expanded its Advanced Materials Science (AMS) implant portfolio with the clearances, along with the commercial launch of the Modulus extreme lateral interbody fusion (XLIF) dual-sided plate. NuVasive’s Modulus anterior lumbar interbody fusion (ALIF) […]
Invivo Therapeutics raises $3m
InVivo Therapeutics (NSDQ:NVIV) filed an SEC Form D to confirm the sale of more than $3 million in options, warrants and/or other rights to acquire other securities. The Cambridge, Mass.-based spinal cord injury treatment developer sold its entire offering amount of $3,022,576. It included a private placement of warrants to purchase more than 1.7 million shares […]
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