2012

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 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 […]

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 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 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, […]

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 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 […]

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. […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]