Category: Food & Drug Administration (FDA)
FDA regulators and Dept. of Homeland Security officials are co-hosting a public meeting to discuss cybersecurity in medical devices.
MASSDEVICE ON CALL — The FDA announced that it will hold a public meeting in October to discuss cybersecurity in medical devices.
Co-hosted with the Dept. of Homeland Security, the 2-day summit will bring together a variety of healthcare stakeholders to discuss areas of vulnerability and best approaches to shoring up the digital defenses of medical systems.
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