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.
Lightbulb company Royal Philips is swapping its heritage for the consumer healthcare business.
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.
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- Biosimilar uptake will require companies to tell a trustworthy backstory
- Lawmakers propose allowing pharma companies to share some off-label information
- Apple's ResearchKit: Five Guidelines for Pharma
- Everyday Health buys rare-disease agency Cambridge BioMarketing