Devices & Diagnostics Letter

Lawmakers and watchdog groups are putting a brighter spotlight on the FDA, demanding the agency, HHS and the White House take action to ensure whistleblower protections and investigate allegations of inappropriate email monitoring by the drug regulator.

U.S. lawmakers should level the playing field for U.S. companies competing in the global market by adopting reforms that reward investment in innovative technologies, AdvaMed President Stephen Ubl said in written testimony submitted for a Thursday House Ways & Means Committee hearing.

A revision to Massachusetts’ strict “gift ban” law gives devicemakers more flexibility when teaching healthcare providers how to use new medical technologies.

Any future guidance on pediatric X-ray devices should take into account that most imaging devices at one time or another will be used for children, a roundtable of experts told the FDA during a July 16 public workshop.

The sluggish cardiac rhythm management (CRM) sector should hit bottom by early 2013 and then begin a slow comeback, St. Jude Medical CEO Dan Starks said in a Wednesday conference call to discuss the company’s second quarter 2012 earnings.

Siemens Healthcare Diagnostics has received its second FDA warning letter this summer, following an inspection of the company’s Newark, Del., plant.

Makers of home use medical test kits must be able to demonstrate that they can be properly used by people who lack specialized training, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) says in new guidance for notified bodies.

Johnson & Johnson’s Synthes acquisition closed less than two weeks before the end of the 2012 second quarter, but the division still contributed 1.2 percent to J&J’s worldwide operational sales growth.

Claims made in marketing materials for Bausch + Lomb contact lenses have landed the Rochester, N.Y., company an FDA warning letter.

Manufacturers and regulators can be more confident about the rigor of trial data coming from emerging markets as the quality of studies appears to be on par with trials in developed nations, a new study concludes.