Category: Food & Drug Administration (FDA)
Innovative needle design to enhance patient safety.
LAWRENCE, Mass. --
NxStage Medical, Inc. (Nasdaq: NXTM), a leading manufacturer of innovative dialysis products, today announced its single needle technology, OneSite, has received FDA clearance.
NxStage Medical wins FDA clearance to market its OneSite single needle dialysis technology for use with its portable systems.
Massachusetts-based dialysis devices maker NxStage Medical (NSDQ:NXTM) won FDA clearance for its OneSite technology, cutting down on the number of needles dialysis patients must endure during therapy.
The FDA widens its clearance of Intuitive Surgical's da Vinci S and Si robotic systems to include use in benign, base of tongue resection surgeries.
The U.S. Food & Drug Administration releases a list of pre-market approvals granted in July 2014.
Summary of PMA Originals & Supplements Approved
- Originals: 1
- Supplements: 81
Summary of PMA Originals Under Review
- Total Under Review: 50
- Total Active: 24
- Total On Hold: 26
Summary of PMA Supplements Under Review
Roche lands FDA clearance for its Accu-Chek Aviva Expert, the 1st diabetes management device to combine a blood glucose meter with an insulin calculator.
Biotech titan Roche secured a landmark FDA win with clearance for its Accu-Chek Aviva Expert blood glucose meter, the 1st of its kind with a built-in insulin calculator to help guide patient therapy.
ACCU-CHEK Aviva Expert offers people with diabetes a new and easy way to simplify complex calculations to deliver precise insulin dosing advice.