Archive for the Category ◊ FDA News ◊

• Monday, March 10th, 2014

Baxter Initiates U.S. Voluntary Recall of One Lot of Peritoneal Dialysis Solution Due to Container-Closure Non-Integrity March 5, 2014 – DEERFIELD, Ill.,– Baxter International Inc. announced today it has initiated a voluntary recall in the United States of a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 6000mL (Ambu-Flex II) to the […]

• Friday, January 24th, 2014

Johnson & Johnson subsidiary Codman Neuro’s recall of its Trufill n-BCA liquid embolic system gets labeled as a Class I measure by the FDA. Codman Neuro, a division of Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes, said the FDA labeled its Trufill n-BCA liquid embolic system recall as Class I, the federal watchdog agency’s highest-risk classification. The […]

• Wednesday, January 22nd, 2014

Greatbatch files for European CE Mark for its spinal cord stimulation system, hoping to land marketing approval the treatment of chronic pain of the trunk and limbs. Greatbatch (NYSE:GB) filed a CE Mark application for its spinal cord stimulation system with German notified body TÜV SÜD America. The spinal cord stimulation system comes from Greatbatch’s subsidiary, […]

• Tuesday, January 21st, 2014

St. Jude Medical quietly accepts FDA premarket approval for its Cool Flex ablation catheter and ablation generator for treatment of arrhythmia. Medtech titan St. Jude Medical (NYSE:STJ) won FDA premarket approval for its Cool Flex cardiac ablation system with indication to treat irregular heart rhythms. St. Jude accepted the win quietly, with not announcements listed on its site […]

• Friday, January 17th, 2014

Google Inc. sent employees with ties to its secretive X research group to meet with federal regulators who oversee medical devices, raising the possibility of a new product that may involve biosensors from the unit that developed computerized glasses. The meeting included at least four Google workers, some of whom have connections with Google X – and […]

• Friday, January 17th, 2014

The FDA issues a warning letter to Philips over its late notification for the recall of a component of its InnerCool RTx temperature control device. The FDA dinged Philips (NYSE:PHG) for tardiness in its notification of the recall of a component for its InnerCool RTx body temperature control device in a warning letter sent last month. Philips […]

• Wednesday, December 11th, 2013

NEW YORK, Dec. 5, 2013 — /PRNewswire/ — JARVIK HEART, Inc., a privately-held company that develops and manufactures cardiac assist devices, announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval to the Shonin (or pre-market approval) application submitted by Century Medical, Inc., (CMI) for the Jarvik 2000 Heart, a small Left […]

• Thursday, December 05th, 2013

FDA Clears TYRX Antibacterial Envelope for Use with Spinal Cord Neuromodulators MONMOUTH JUNCTION, N.J.–(BUSINESS WIRE)–TYRX, Inc. announced today that it has received U.S. Food and Drug Administration (FDA) clearance for expanded indications in marketing the AIGISRx N Antibacterial Envelope for use with spinal cord neuromodulators. This comes after the recent FDA clearance of the AIGISRx […]

• Thursday, December 05th, 2013

Dec. 3, 2013 — Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices. The […]

• Wednesday, November 27th, 2013

23andMe Inc., the Google Inc.-backed DNA analysis company co-founded by Anne Wojcicki, was told by U.S. regulators to halt sales of its main product because it’s being sold without “marketing clearance or approval.” Machines in the 23andMe labs, which provides genetic information to consumers. Photographer: Brent Humphreys/Redux The Saliva Collection Kit and Personal Genome Service, or PGS, […]