FDAnews Device Daily Bulletin

Gut instincts can play a crucial role in telling devicemakers what they need to know in selecting suppliers, an FDA official says.

Stryker Orthopaedics is facing a lawsuit alleging damages caused by the company’s titanium alloy Rejuvenate hip system.

The Supreme Court decision in June upholding the Affordable Care Act leaves in place a tax on medical devices that threatens thousands of American jobs and our global competitiveness.

An Amsterdam-based medical device regulatory consulting firm announced today that it has opened its U.S. headquarters at the Cambridge Innovation Center.

Medtronic has announced it will acquire China Kanghui Holdings for $816 million.

Medtronic touted the launch of its latest renal denervation trial, testing its Symplicity system against drug therapy alone in patients in Japan.

The FDA has granted Boston Scientific regulatory approval for its S-ICD System, the world’s first and only commercially available subcutaneous implantable defibrillator for the treatment of patients at risk for sudden cardiac arrest.

Seeing growing interest from global medical device companies in manufacturing in China, Singaporean firm Forefront Medical Technology is investing $10 million in a plastics molding and extrusion facility in East China to tap into the market.