Tag-Archive for ◊ U.S. Food and Drug Administration ◊

• 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

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 […]

• 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 20th, 2013

The FDA slaps its highest-risk Class I status on Medtronic’s recall after at least 1 patient is reportedly injured by a broken coronary surgery guidewire. MASSDEVICE ON CALL — Medical device titan Medtronic (NYSE:MDT) announced late last week that the FDA had put its highest-risk label on a company recall of certain guidewires. The agency deemed the recall […]

• Wednesday, November 20th, 2013

AtriCure Receives FDA Approval for Investigational Study to Evaluate Stroke Prevention in Atrial Fibrillation AtriClip Left Atrial Appendage Exclusion System to be Evaluated as Alternative to Anti-Coagulation Therapy WEST CHESTER, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading developer of solutions to treat atrial fibrillation (Afib), today announced the Food and Drug Administration’s (FDA) approval to […]

• Saturday, November 16th, 2013

Lumenis Receives US FDA and Japanese MHLW Clearance for Array(TM) LaserLink(TM) Pattern Scanning Device for Multi-Spot Retinal Laser Treatment SAN JOSE, CA–(Marketwired – Nov 15, 2013) – Lumenis Ltd., the world’s largest medical laser company for ophthalmic, surgical and aesthetic applications, today announced that the company has received US FDA and Japanese MHLW clearance for […]

• Thursday, November 14th, 2013

Johnson & Johnson has tentatively agreed to a settlement that could reach up to $4 billion to resolve thousands of lawsuits filed by patients injured by a flawed all-metal replacement hip, said two lawyers briefed on the plan. The tentative plan, which must win court approval, represents one of the largest payouts for product liability […]

• Tuesday, November 12th, 2013

A new FDA memo and physician survey draws renewed attention to the increase in reports associated with Intuitive Surgical’s da Vinci robot-assisted surgical system, which has been the subject of twice as many adverse event reports so far in 2013 than during the same period in 2012. The FDA this month released a mixed bag […]

• Monday, November 11th, 2013

MINNEAPOLIS – Nov. 7, 2013 – Medtronic, Inc. (NYSE:MDT) today announced FDA approval of its Lead Integrity Alert (LIA) software for use with non-Medtronic leads. Proprietary and exclusive software that resides in Medtronic defibrillators, LIA is now approved to report performance issues on Durata and Riata defibrillator leads (St. Jude Medical) and Endotak (Boston Scientific) […]