Rumored presidential candidate Sen. Elizabeth Warren (D-MA) wrote a letter to the administrator of the Centers for Medicare & Medicaid Services focused on an issue of great concern to the med tech employee constituency: Unique Device Identification. Co-authored with Sen. Charles Grassley (R-IA), the letter to Administrator Marilyn Tavenner urges CMS to side with various medical associations, think tanks and private insurance companies in support of including UDI information in insurance claims forms.
Home healthcare is a buzzphrase these days, and with good justification, including the aging population and a growing focus on cost-cutting within the healthcare system. Now NxStage Medical has won an expanded indication from the FDA for overnight home use of its System One hemodialysis system.
BioCryst Pharmaceuticals won its first-ever FDA approval for a new treatment and subsequently saw its shares slide as analysts yawned over its sales potential.
German drugmaker Fresenius Kabi's U.S. operation has completed the recall of half a million vials of drugs started more than two years ago because the glass had fractures and might contain particles.
The FDA issued a warning against unnecessary and excessive fetal ultrasound imaging and heartbeat monitoring using Doppler heartbeat monitors, advising women not to receive or perform the procedures at home or for nonmedical reasons.
Drugmaker Pozen says its API supplier has done everything the FDA asked after noting issues in an April plant inspection and the company resubmitted its application in July. But the FDA's compliance division has been too busy to get back to the plant and see for itself, and so the agency has sent Pozen a second CRL with "identical wording."
The FDA approved Sanofi's Fluzone Intradermal Quadrivalent in adults age 18 through 64.
Santa Ana, CA-based MP Biomedicals has nabbed FDA approval for the first supplemental test designed to better identify blood donors that have tested positive for human T cell lymphotropic virus.
Roche has launched the Laboratory-in-a-tube technology it acquired when it bought iQuum in April for $275 million up front and up to $175 million in milestone payments. Roche is making the system available in the U.S. and Europe.
Roche's Lucentis may now have a bigger jump on Eylea in diabetic retinopathy. The Swiss drugmaker's Genentech unit won the FDA's "breakthrough" designation for that indication on Monday. And Lucentis was already on the FDA's priority review track, with a decision date in February.