WEST PALM BEACH, Fla., March 19, 2012 /PRNewswire via COMTEX/ — SurgLine International, Inc. (SGLN.PK) and SurgLine, Inc. (“SurgLine”) today announced that the management team and certain consultants to SGLN and SurgLine have completed the return of over 1,000,000,000 shares of common stock to the Company. This announcement is the follow up to the previous […]
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Exactech Announces Expiration of Deferred Prosecution Agreement
GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq:EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today that the Deferred Prosecution Agreement (DPA) entered into effective December 7, 2010 with the United States Attorney’s Office for the District of New Jersey (USAO) has expired. The Company satisfied […]
Paradigm Spine, LLC Announces Strategic Promotions and Hiring of Key Personnel to Ensure Long-Term Growth and Success
NEW YORK, March 14, 2012 /PRNewswire/ — Paradigm Spine, LLC, a leading provider of spinal implant technologies, announces the promotion and addition of key strategic personnel to strengthen operations and further position the Company for long-term growth.Guntmar Eisen has been promoted to the position of President and Chief Operating Officer (“COO”). As co-founder of Paradigm […]
DFINE Announces First U.S. Patient Treated with the STAR Ablation System
SAN JOSE, Calif., Mar 14, 2012 (BUSINESS WIRE) — DFINE, Inc., the developer of minimally invasive radiofrequency (RF) targeted therapies for the treatment of vertebral pathologies, today announced the first U.S. patient was successfully treated using the Spinal Tumor Ablation with Radiofrequency (STAR(TM)) System. The FDA-commercially cleared, percutaneous Targeted RadioFrequency Ablation (t-RFA(TM)) device delivers energy […]
Mazor Robotics Signs Agreement with Distributor for China
CAESAREA, Israel, Mar 12, 2012 (BUSINESS WIRE) — Mazor Robotics Ltd (tase:MZOR), the leader in innovative surgical robots and complementary products for spine surgery, signed an agreement with Cicel Science & Technology Co., Ltd. to distribute its Renaissance(TM) system in China. Renaissance is Mazor Robotics’ next generation surgical guidance system for spine procedures.As part of the […]
Trans1 announces progress toward goals
Medical device-maker Trans1 has several pieces of good news to share with stakeholders. In a conference call with analysts Thursday, officials of the Wilmington-based company discussed fourth quarter operating results as well as progress in gaining physician reimbursement for its spinal fusion procedures.Trans1 CEO Ken Reali told analysts “We have made good progress on our […]
FDA warns J&J’s Synthes over manufacturing violations
The US Food and Drug Administration (FDA) has warned Swiss-based Synthes, the medical device manufacturer currently in the middle of a takeover from Johnson & Johnson (J&J), it could face a financial penalty if it doesn’t fix problems at its Pennsylvania facility.The good manufacturing practice (GMP) violations involved such devices as polyaxial heads and pedicle […]
Synthes gets warning letter from FDA
EAST GOSHEN — U.S. regulators warned Swiss medical device maker Synthes Inc. about violations at its Brandywine plant on Goshen Parkway and said the company may have to pay a fine if it fails to fix the problems. Synthes did not have a good way of monitoring and investigating complaints about its devices, the Food […]
Titan Spine Creates Subsidiary to Support Sales Expansion into Europe
MEQUON, Wis. — Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that it recently created Titan Spine Europe, GmbH, a subsidiary that will support the company’s sales expansion efforts into Europe. The facility, located in Laichingen, Germany, is centrally located to serve as […]
Amedica Announces Launch of New Facet Joint Implant
SALT LAKE CITY, March 6, 2012 /PRNewswire via COMTEX/ — Amedica Corporation, a spinal and reconstructive implant and instrument manufacturer, focused on proprietary silicon nitride (Si3N4) ceramic technologies, announced today the launch of a new spinal implant called Procet(TM). Procet has been designed to treat patients who suffer from low back pain, caused by spinal […]
FDA Evaluation Results for Eminent Spine
Georgetown, TX, February 29, 2012 –(PR.com)– Medical Device company Eminent Spine released a statement this afternoon that the Federal Food and Drug Administration (FDA) has provided a “close out” letter on 2/6/2012 regarding a previous Warning letter. The FDA reported that Eminent Spine has properly addressed the issues and has taken necessary corrective actions. Eminent Spine is pleased with […]
Synthes sued over deaths in connection with bone cement
Synthes Inc. and four former executives involved in an illegal clinical trial of bone cement were sued Thursday in California Superior Court by the families of two patients who died on the operating table. Ryoichi Kikuchi and Barbara Marcelino were both 83 when they died after surgeons operating at the John Muir Medical Center in […]
K2M Expands Complex Spine Product Offering with 510(k) Clearance for SANTORINI™ Corpectomy Cage Systems
LEESBURG, Va.–(EON: Enhanced Online News)–K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies and minimally invasive procedures, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the SANTORINI™ Corpectomy Cage Systems. This new addition to the company’s growing complex spine […]
Orthofix appoints new management team member
Orthofix has announced the appointment of Brad Niemann to a management role focusing on operations in the company’s stimulation business.Mr Niemann has been named senior vice-president for commercial operations for the medical technology manufacturer’s global spine business unit, a role that will leverage his 14 years of experience and success in the industry.Robert Vaters, president […]
Alphatec Spine Announces Management Realignment to Prepare Company for Next Phase of Global Growth
Alphatec Holdings, Inc., the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, today announced that it has realigned the leadership roles of Dirk Kuyper and Les Cross.Mr. Kuyper, […]
Osseon® Announces International Distribution Agreement with Aesculap
SANTA ROSA, Calif., Feb. 27, 2012 /PRNewswire via COMTEX/ — Osseon® Therapeutics, Inc. announced today that the company has entered into an International Distribution Agreement with Aesculap AG to distribute its vertebral compression fracture (VCF) treatment devices, including its new CE-Mark approved device – Osseoflex® SB (steerable balloon) in select regions of Europe and Asia. […]
Johnson & Johnson’s choice of Gorsky as new CEO reflects importance of Synthes deal, observers say
Johnson &Johnson’s decision to name Alex Gorsky as its next chief executive officer reflects the importance of the recent acquisition of the orthopedics maker Synthes and future deals like it that will be necessary to grow the healthcare giant, two company observers said yesterday.The 51-year-old Gorsky, who oversees Johnson &Johnson’s medical device business, was named […]
New J&J CEO must fix sullied image, integrate Synthes
Johnson & Johnson’s new CEO will need to take bold steps to help the giant healthcare company repair its reputation following costly product recalls and oversee its biggest acquisition ever.Alex Gorsky, 51, vice chairman of the Medical Device and Diagnostics Group, rose through the ranks of J&J from his start as a salesman in 1988. […]
NuVasive Has Been Bloodied, But The Growth Story Isn’t Broken
These have not been the easiest of times for small-cap orthopedics company NuVasive (NUVA). Not only has the company gotten caught up in the generalize spine market malaise, but the company’s litigation with Medtronic (MDT) has been a significant overhand for some time. With solid share in minimally invasive procedures and meaningful new products on […]
J.&J. Offers Concessions to Win Approval for Synthes Deal
LONDON — Johnson & Johnson has submitted concessions to the European Union in an effort to complete its $21.3 billion takeover of the Swiss-American medical tools maker Synthes.The announcement comes after European authorities had expressed concerns that the deal might reduce competition in the medical devices industry. Regulators are now expected to rule on the […]
Medtronic still struggling with spine, ICD sales
The world’s largest stand-alone medical device maker said sales in each of those units fell 9 percent in the fiscal third quarter, showing no improvement from the poor performance that has lasted for several years.Medtronic’s business has been hurt by a series of setbacks, most recently the weak global economy that has pressured governments to […]
Orthopedic Devices Market – Growth at a CAGR of 7.6% from 2010 – 2017
Dallas, TX — (SBWIRE) — 02/20/2012 — The global orthopedic devices market is forecast to reach a value of $61.3 billion by 2017 from a market value of $36.7 billion in 2010 at a CAGR of 7.6%. Emerging markets will provide the most growth for orthopedic device companies in the near future. The US and […]
Accelmed in talks to buy US spinal therapy co
Dr. Uri Geiger, Mori Arkin’s partner in medical devices investment fund Accelmed, revealed today at a conference held by investment house Landmark Ventures that the firm was in talks to buy a leading company in spinal therapies. Geiger said that the fund would invest several tens of millions of dollars in the company, which already […]
Global Market for Spinal Nonfusion Technology Devices to Reach over $800 Million by 2016
TORONTO–(EON: Enhanced Online News)–According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the global market for spinal nonfusion technology devices will show significant growth to $814 million by 2016. This growth is based on an expanding elderly population worldwide, increased surgeon training on nonfusion technologies and techniques, and economic growth […]
Titan Spine Acquires Additional Patent Protection for its Spinal Implant Surface Technologies
MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that it has acquired two patents related to its current and future surface modification techniques. The first patent protects the company’s existing manufacturing process that has been shown to produce superior bone-forming activity […]
Amedica Corporation Announces Launch of Valeo® VBR, Silicon Nitride Implant
SALT LAKE CITY, Feb. 14, 2012 — /PRNewswire/ — Amedica Corporation, a spinal and reconstructive implant and instrument manufacturer focused on unique silicon nitride (Si3N4) ceramic technologies, announced today the launch of an extension of its Valeo product line. The Valeo VBR will utilize the unique material characteristics of silicon nitride, which may increase fusion […]
Disruptive medical devices business model? First online-only spinal implants company thinks so
A startup that bills itself as the first online-only spinal implants maker has launched its first product, a cervical cage system.So does San Diego-based Eisertech represent a new, disruptive business model for a certain portion of the medical devices market, namely for customers and products that don’t require much in-the-field support from sales reps? Or […]