The approval follows three advisory panel reviews and a complete response letter.
Medtronic, as part of the settlement, will pay $602,000 to a whistleblower to settle charges it caused physicians to submit false claims to federal health programs.
The company is calling the move a withdrawal, as opposed to a recall.
The finance, electric and broadcasting company has taken a $1-billion interest in DNA technology.
Covidien is buying ingestible-camera company Given Imaging.
The current number is reported to hover around $4 billion.
The agency issued final guidance on mobile apps, saying it will focus only on a subset that present the greatest risk to patients if they don't work correctly.
Proteus Digital Health's ingestible sensor shows utility as an adherence tool for those on psych meds, a study suggests.
Device maker Preventice says the peel-and-stick monitor has the potential to go beyond the critical care market and into the sports world.
Driven by consolidation in the healthcare industry, J&J is reuniting Ethicon, Inc. and Ethicon Endo-Surgery to present surgeons and health systems with a single face.
The company expects emerging markets to rise in importance and says it's scoping out possible device acquisitions.
In a big win for the device industry, Senators voted overwhelmingly on a symbolic— but politically potent—motion to scrap the 2.3% device excise tax.
A deal with QualcommLife aims to fuse WebMD content with a suite of disease state management tools.
What changes in marketing or audience viewing habits might impact pharma's media investment this year? Media buyers weigh in on the hot channel trends.
A new campaign from J&J's DePuy Orthopedics, aimed at raising awareness of joint replacement, features Baby Boomers' letters to their younger selves.
After almost a year of negotiations, Baxter has reached a $4 billion deal for Swedish firm Gambro AB as it makes a play for the kidney dialysis market.
Diagnostics firm MedMira gets a contract from the US Army to develop a screening tool, and the FDA proposes some new device guidelines.
Endo is restructuring, bringing its four operating units under the same corporate roof and rebranding to reflect its diversification out of its origins in pain and urology drugs.
Sanofi is re-upping its social media-driven Data Design Diabetes Innovation Challenge contest, which last year kicked up a wealth of innovative ideas and buzz for the price of $200,000 in prize money and a few salaries.
The FDA is moving cautiously on a call by the Institute of Medicine to scrap the approvals process for many medical devices.
FDA issued draft guidance on mobile medical apps, focusing narrowly on those programs that augment regulated medical devices or turn mobile devices into medical devices.
A company that markets a pill cap with a built-in cellular connection puts a social twist on getting patients to take their meds.
Sanofi-Aventis US is rolling out a consumer campaign for its Lantus SoloStar pen aimed at getting people with type 2 diabetes to think differently about insulin, while Novo Nordisk revs up another racing-themed social media effort for its FlexPen.
Bayer Diabetes Care partnered with Nintendo on a glucose meter for kids that incorporates gaming.
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