The FDA approved the weight-management drug Qsymia, a combination of the two FDA-approved drugs phentermine and topiramate, in an extended-release formulation. The agency also is requiring a long-term outcomes trial to assess the drugs cardiovascular effects.

Edward Hospital & Health Services has installed 12 wireless DR systems from Carestream.

Looking to make good on previous promises to foster rather than hinder innovation in the medical device industry, the FDA has released draft guidance outlining its updated pre-Investigational Device Exemption (IDE) program. According to an item announcing the guidance in the July 13 Federal Register, the updating includes giving IDE a simpler name: the Pre-Submission Program.

At Health Imaging, we like to think of July and August as a bit of downtimethe breather before the run-up to RSNA. That characterization may represent fantasy more than reality.

The FDA has approved a stem cell therapy that will work to repair damage caused by heart attacks, according to a release from the California Institute for Regenerative Medicine. The approval will be the first-in-human use for the therapy in clinical trials.

The FDA issued a Class 1 recall of Alere Triage cardiac diagnostic products because the rapid test system has the potential to be defective.

The FDA has released the final versions of guidelines for the premarket notification and approval of computer-assisted detection technology applied to radiology images and radiology device data.

Today, sadly, marks my last day with Cardiovascular Business. For almost three years, I have had the pleasure and honor of working with the crew here at CVB and all of you. It is a bittersweet goodbye for me, but I am moving on to start a new adventure in Beantown.