Digital health: Inside Apple’s meeting with the FDA
June 10, 2014 by Arezu Sarvestani
FDA regulators finally opened up about last year’s chat with consumer technology giant Apple, opening the books on a meeting that spurred a lot of speculation about the company’s healthcare prospects.
According to meeting minutes obtained through a Freedom of Information Act request filed by 9to5Mac.com, Apple spoke with the FDA about its “moral obligation to do more” with its technology, especially given the capability of its smartphones to support sensors that may have implications for how users track and view their health. Read more
FDA details plan to improve medical device arm
June 12, 2014 by Brad Perriello
The FDA yesterday detailed a plan to overhaul procedures at its medical device arm, the Center for Devices & Radiological Health, based on recommendations from an outside auditor’s report last year.
The FDA said it will implement a 2-stage process to address the 4 main recommendations of the report consultants Booz Allen Hamilton issued late last year. If the FDA wants to meet the promises it made during the latest round of medtech user fee negotiations, the firm advised, it needs to establish more consistency in decision-making, ramp up its training programs and address quality management issues to make the review process more transparent and standardized for reviewers and the companies undergoing review. Read more
FDA panel OKs Bard’s Lutonix balloon
June 13, 2014 by Ingrid Mezo
An FDA advisory panel yesterday recommended approval for the Lutonix drug-eluting balloon made by C.R. Bard.
The FDA’s Circulatory Systems advisory panel unanimously voted in favor of the Lutonix DCB, finding it safe & effective and ruling that its benefits outweigh its risks, although they did note data for effectiveness was not robust and that further study of the device’s effects on women is needed. Read more
Cohera Medical wins FDA panel date for TissuGlu surgical adhesive
June 10, 2014 by Brad Perriello
Cohera Medical said it’s won a date with an FDA advisory panel in August for its TissuGlu surgical adhesive.
Cohera said the FDA’s General & Plastic Surgery panel is slated to convene August 1 to review its pre-market approval application for TissuGlu, which is designed “for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.” Read more
FDA approves Medtronic’s CoreValve for high-risk patients
June 12, 2014 by Brad Perriello
Medtronic said the FDA expanded the approval for its CoreValve transcatheter aortic heart valve to include patients at high risk from open heart surgery.
The CoreValve device was acquired by Medtronic for $700 million plus milestones in 2009. Read more
