Cook Medical gets FDA panel’s backing for stent
The device would be the first drug-coated stent approved in the U.S. to treat peripheral vascular disease in the largest artery of the upper leg.
The device would be the first drug-coated stent approved in the U.S. to treat peripheral vascular disease in the largest artery of the upper leg.
Peripheral vascular devices, including stents, angioplasty balloons and synthetic grafts, generated $4.3 billion in global revenue last year and may earn $5.6 billion in 2014.
The molecular-imaging company is trying to transition its business model and get beyond a going-concern warning.
The next four years could be rough for makers of medical devices and orthopedic implants, including Bloomington-based Cook Medical Inc. and Warsaw-based Zimmer Holding Inc. and Biomet Inc.—and not because of the 2010 health reform law.
The Warsaw-based company has sued seven law firms this year and sent warning letters to at least three more, saying their ads and Internet postings distorted the safety record of its $1.8 billion-a-year knee business.
Warsaw-based DePuy Orthopaedics expects to spend $20 million on manufacturing equipment and $7 million on research and development equipment and have it installed before 2014.
Rochester Medical Implants plans to move operations from Rochester to Noblesville in October. The company has 28 employees.
Medical imaging equipment maker Positron Corp. has agreed to move its operations to Noblesville, where it plans to invest $55 million to open a high-tech facility that will make isotopes used in cardiac PET scans.
Warsaw-based Zimmer Holdings Inc. has enjoyed eight years as the giant in the industry of selling knee- and hip-replacement implants to hospitals. But now it faces a challenge from Johnson & Johnson.
Industry cluster in northern Indiana has adapted to every other change in health care, and will absorb tissue regeneration, too.
Indianapolis-based Medivative Technologies plans to build a 9,000-square-foot addition to its east-side facility and spend $2.5 million to equip it. The expansion should create 15 jobs.
The total annual cost for one researcher at Lilly might run $300,000 to $350,000 a year. The figure at Crown Bioscience is one-third of that, said a company executive.
TechPoint-led initiative is meant to help bring inventions to market by giving them a trial in real-world setting.
The Warsaw-based maker of orthopedic implants has filed suit to stop a Detroit-area law firm from making allegedly false claims and using its trademarks on websites designed to attract plaintiffs to sue Zimmer over one of its knee-replacement implants called NexGen.
The founder of Bloomington-based life sciences giant Cook Group Inc. and the wealthiest man in Indiana leaves a legacy of dozens of historic structures saved from decay or demolition. He also was a major donor to Indiana University and its athletics department.
Delays getting new diabetes meters into the U.S. market appear to have tripped up Roche Diagnostics Corp. on its way to acquiring a key software vendor.
An executive at the Noblesville firm’s parent company said the departures of CEO Don Dumoulin and Chief Financial Officer Yun Kim were the result of a “mutual agreement.” A search is under way for replacements to lead one of the area’s largest medical device manufacturers.
A Minnesota judge has signed off on a plea agreement that calls for Boston Scientific Corp.'s Guidant unit to pay $296 million for failing to properly disclose changes made to some implantable heart devices, but added three years of probation to the deal.
Boston Scientific Corp.'s Guidant unit hopes to end a criminal case accusing it of failing to properly disclose changes made to some implantable heart devices when it appears in court Wednesday.