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Spinal Elements

FDA clears Spinal Elements’ surface coating technology

November 13, 2018 By Nancy Crotti

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 […]

Filed Under: Food & Drug Administration (FDA), Implants, Orthopedics, Spine Tagged With: FDA, Spinal Elements

Neovasc taps former Boston Scientific CRM vet Colen for CEO | Personnel Moves January 22, 2018

January 22, 2018 By Fink Densford

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 […]

Filed Under: Business/Financial News Tagged With: Bayer, biogennix, Boston Scientific, Bristol-Myers Squibb Co., Cardinal Health, Dentsply Sirona, gilupi, imaginmedical, Medtronic, neovasc, Spinal Elements

Spinal Elements lifts former COO Blain to the corner office | Personnel Moves November 30, 2017

November 30, 2017 By Fink Densford

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 […]

Filed Under: Business/Financial News Tagged With: Abbott, Alphatec, Apica Cardiovascular, Bovie Medical Corp., Cardiovascular Systems Inc., Dentsply Sirona, Guidant Corp., Lima Corporate, Medical Device Innovation Consortium, MedLumics, MedTech Europe, Medtronic, Nuvasive, OneMedNet, Sanofi-Aventis, Smith & Nephew, Spinal Elements, Tissue Regenix

Zimmer Biomet prez, CEO Dvorak unexpectedly resigns | Personnel Moves, July 12, 2017

July 12, 2017 By Fink Densford

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 […]

Filed Under: Business/Financial News Tagged With: Abiomed, Accuray Inc., Amendia, Boston Scientific, C.R. Bard, Cochlear Ltd., conformis, GE Healthcare, InVivo Corp., IsoRay, Johnson and Johnson, Lidco, Lumicell, Neurometrix, Philips, portal instruments, RenalGuard Solutions, Sanofi-Aventis, Spinal Elements, stjudemedical, Stryker, TherOx Inc, Zimmer Biomet

Amendia rebrands under acquired company moniker Spinal Elements

July 10, 2017 By Fink Densford

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 […]

Filed Under: Business/Financial News Tagged With: Amendia, Spinal Elements

Amendia picks up Spinal Elements

April 17, 2017 By Fink Densford

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 […]

Filed Under: Mergers & Acquisitions, Spine Tagged With: Amendia, Spinal Elements

NASS 2016: Interest grows in surgical robotics for spinal procedures

October 31, 2016 By Sarah Faulkner

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 […]

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Filed Under: Implants, Spine, Surgical Tagged With: 4WEB Medical, depuysynthes, Globus Medical, Life Spine, mazorrobotics, Medacta, Medtronic, Mighty Oak Medical, NASS 2016, North American Spine Society, Spinal Elements, Spinal Simplicity, Spineology, Stryker, Synaptive Medical, Zimmer Biomet

CMS propose 4 changes which could mean major new costs for medical device makers | Regulatory news for the week of July 28, 2014

July 29, 2014 By MassDevice Leave a Comment

Medicare's Sunshine Act changes could hit device makers in the pocketbook

July 22, 2014 by Arezu Sarvestani

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Centers for Medicare and Medicaid Services (CMS), Emergo Group, Spinal Elements

FDA dings Spinal Elements for design changes, unreviewed claims

July 17, 2014 By Arezu Sarvestani Leave a Comment

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.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Spine Tagged With: Spinal Elements, Warning Letter

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