The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Orthofix International is one of the companies named in a whistleblower lawsuit accusing the group of bone-growth stimulator manufacturers of reimbursement fraud.
It’s not the first time the Boston-based orthopedics maker has run afoul of federal authorities and the False Claims Act. In 2003, the company agreed to pony up nearly $1.6 million to settle allegations that it submitted false claims to TRICARE, the military’s healthcare program.
U.S. Attorney Michael Sullivan is making his last week on the job a busy one.
Just five days before he leaves public service for the oak-trimmed corridors of private practice, Sullivan announced a third guilty plea in the federal investigation of off-label promotion by former sales reps for Stryker Biotech.
The federal Food & Drug Administration shot down Stryker Corp.‘s application for expanded use of its bone-growth putty after a panel of outside experts voted 6-1 against allowing the expansion, the Reuters news service reported.
The watchdog agency’s panel found that bias may have influenced subjects in clinical trials for the medical device giant’s OP-1 putty, a genetically engineered protein used to stimulate bone growth in spinal surgeries.
Stryker’s biotech division is headquartered in Hopkinton.
Stockholders of Orthofix International NV fought back a proxy challenge by a New York-based hedge fund.
The McKinney, Texas-based orthopedic device manufacturer said its shareholders beat back an attempt by Ramius LLC to oust four current board members and install their own people.
Orthofix also runs offices in Boston and a production facility in Springfield.
You’d be hard-pressed to argue that the past decade hasn’t been a good one for medical device companies focused on the spine (Especially with me. Full disclosure: I’m involved in two spine startups. I’m on AxioMed’s technical advisory panel and I’m a minority shareholder of Innovative Surgical Designs. At the time of this writing, I also own shares of TranS1).
Sometimes it seems like you can’t swing a pedicle screw without hitting a new spine start-up. Anthony Viscogliosi recently estimated that are 200 venture capital-backed spine companies.
ConforMIS Inc. added a pair of medical device industry veterans to its executive roster.
The Burlington orthopedic implant maker appointed Robert Phelps as SVP of sales and David Cerveny as general counsel and VP of intellectual property.
Phelps’ more than 25 years in medical devices includes stints at Biomet Inc., Biosphere Medical and Johnson & Johnson.
Four orthopedic device makers cleared federal criminal charges and a fifth “satisfactorily completed” its non-prosecution agreement with the U.S. Attorney’s office in Newark, the Dow Jones news service reported.
IlluminOss Medical got the OK to market its photodynamic bone stabilization system to European Union nations.
The product, which replaces pins and screws with a small incision and a polymer system to fix hand, wrist, clavicle and arm fractures, recently received a CE marking, certifying that it has met EU safety and health requirements and giving the company access to EU nations.
Delays at the federal Food and Drug Administration and dwindling cash resources will force Cyberkinetics to close its doors for good, The Boston Globe reported.
Two former executives from Johnson & Johnson and Stryker raised $1 million to fund the development of a device that uses radio frequencies to repair torn or frayed cartilage.
NuOrtho Surgical Inc. in Fall River raised the money from private investors and “individuals familiar with the orthopedic industry,” according to a press release.
The funds will be used to file for a 510k premarket notification with the U.S. Food and Drug Administration, ahead of a planned 2010 launch of NuOrtho’s first product.
Phase One Medical LLC sold its anchoring technology line to Nitinol Devices & Components of Fremont, Calif., for an undisclosed amount.
The deal was negotiated by Hatch Medical LLC, a technology brokerage firm, with which Phase One has collaborated in the past.
The anchoring technology is used to secure instruments during minimally invasive cardiovascular and radiology procedures and is one of four product lines the Carver-based company produces.
