Category: Food & Drug Administration (FDA)Syndicate content

FDA seeks public input on medtech hacking | MassDevice.com On Call

September 24, 2014 by Arezu Sarvestani

FDA regulators and Dept. of Homeland Security officials are co-hosting a public meeting to discuss cybersecurity in medical devices.

MassDevice.com On Call

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.

Press Release: NxStage announces FDA clearance of Single Needle Technology

September 18, 2014 by MassDevice

Innovative needle design to enhance patient safety.

Press Release: NxStage announces FDA clearance of Single Needle Technology

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's single-needle home dialysis system comes to the U.S.

September 18, 2014 by Arezu Sarvestani

NxStage Medical wins FDA clearance to market its OneSite single needle dialysis technology for use with its portable systems.

NxStage Medical's single-needle home dialysis system comes to the U.S.

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.

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Intuitive Surgical expands into transoral surgery with new FDA win

September 18, 2014 by Arezu Sarvestani

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.

Intuitive Surgical wins new FDA clearance for da Vinci systems

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Medtech approvals: FDA releases July 2014 PMAs

September 18, 2014 by MassDevice

The U.S. Food & Drug Administration releases a list of pre-market approvals granted in July 2014.

FDA logo

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

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Summary of PMA Supplements Under Review

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