Category: Food & Drug Administration (FDA)Syndicate content

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.

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

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

Sign up to get our free newsletters delivered right to your inbox.

Summary of PMA Supplements Under Review

Diabetes: FDA OKs 1st glucose meter with insulin calculator

September 18, 2014 by Arezu Sarvestani

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.

Diabetes: FDA OKs 1st glucose meter with 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.

Press Release: ACCU-CHEK Aviva Expert, the first and only stand-alone blood glucose meter system with a built-in insulin calculator, is now available

September 18, 2014 by MassDevice

ACCU-CHEK Aviva Expert offers people with diabetes a new and easy way to simplify complex calculations to deliver precise insulin dosing advice.

Press Release: ACCU-CHEK Aviva Expert, the first and only stand-alone blood glucose meter system with a built-in insulin calculator, is now available
Built on an AdaptiveTheme using Drupal by Michael Knapp  mknapp