Spinal Elements said that the FDA has issued 510(K) clearance for the macro-, micro-, and nano-surface structure of its Ti-Bond surface coating technology. The Carlsbad, Calif. company said that a number of products in its portfolio use Ti-Bond, including the most recently introduced Lucent XP height- and lordosis-expandable interbody device. Interbody fusion products with Ti-Bond […]
Neovasc taps former Boston Scientific CRM vet Colen for CEO | Personnel Moves January 22, 2018
Neovasc (NSDQ:NVCN) said today it tapped former Boston Scientific (NYSE:BSX) cardiac rhythm management lead Fred Colen as its new chief executive officer, with former CEO Alexei Marko staying on as an advisor and member of the company’s board of directors. The move comes as part of a company-wide strategy looking to support commercialization efforts for its Reducer […]
Spinal Elements lifts former COO Blain to the corner office | Personnel Moves November 30, 2017
Spinal Elements, previously known as Amendia, said this week it is lifting co-founder and current prez & COO Jason Blain to the position of prez & CEO, effective immediately. Prior to coming on to co-found Spinal Elements, Blain served in various roles with medtech companies Smith & Nephew (NYSE:SNN), Alphatec (NSDQ:ATEC) and NuVasive Inc. (NSDQ:NUVA). Blain is replacing […]
Zimmer Biomet prez, CEO Dvorak unexpectedly resigns | Personnel Moves, July 12, 2017
Zimmer Biomet (NYSE:ZBH) said late yesterday its prez and CEO David Dvorak has resigned from his position at the head of the company, effective immediately, to be replaced on an interim basis by senior VP and CFO Daniel Florin until a permanent successor is named. The Warsaw, Ind.-based company said it is retaining “a leading executive search […]
Amendia rebrands under acquired company moniker Spinal Elements
Amendia said today it is rebranding under the moniker Spinal Elements, the name of a company it acquired in April this year. The Marietta, Ga.-based company said the change “reflect’s the company’s dedication to developing novel medical device technologies, biologics and instrumentation to create positive surgical outcomes,” according to a press release. “We know surgeons want […]
Amendia picks up Spinal Elements
Amendia said last Friday it acquired Carlsbad, Calif.-based spinal device developer Spinal Elements for an undisclosed amount. Spinal Elements produces the Ti-Bond porous titanium coating designed for orthopedic devices, and has upcoming launches planned for its Lucent XP expandable cage and Clutch interspinous device. “The acquisition of Spinal Elements brings a wealth of talent and a […]
NASS 2016: Interest grows in surgical robotics for spinal procedures
Mazor Robotics (NSDQ:MZOR) unveiled its next-generation robot-assisted surgery system and Globus Medical (NYSE:GMED) for the 1st time showcased the functional prototype of its Excelsius platform at the NASS 2016 meeting in Boston last week, signifying an increased interest in robotic surgeons among major players. Mazor developed 3 generations of products over 15 years and does 95% of its business in […]
CMS propose 4 changes which could mean major new costs for medical device makers | Regulatory news for the week of July 28, 2014
FDA dings Spinal Elements for design changes, unreviewed claims
The FDA posted a warning letter against California-based Spinal Elements, saying that the company failed to obtain regulatory clearance for design changes to certain of its intervertebral body fusion devices.
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