Devices
An 8/5-8/11/15 FDA inspection at ARB Medical, Minneapolis, MN, found multiple Quality System Regulation violations in the firm’s manufacturing of polymeric surgical meshes. A 12/22/15 Warning Letter from the agency’s Minneapolis District Office says that violations included: failing to adequately validate, according
Devices
FDA has cleared an OptMed Inc. 510(k) for its BondEase product, a topical skin adhesive intended for the closure of surgical incisions and lacerations as an alternative to sutures and staples. The biocompatible, topical skin adhesive combines a novel polymer technology with a user-friendly delivery device, according to
Devices
Thornhill Research has begin a Class 1 recall of its Moves Ventilator lithium polymer batteries because some have been found unresponsive after storage, not recognized by the main device, and perpetually enabled, according to a recall notice. The portable, computer-controlled transport emergency ventilator is intended to provide continuous or
Devices
FDA has approved the use of Animas Corp.’s Vibe Insulin Pump and Continuous Glucose Monitoring (CGM) System for managing diabetes in children and adolescents (ages two to 17). The device allows patients and their caregivers to view glucose data and administer insulin right from the pump, making it easy
Devices
Stryker has begun a Class 1 recall of its Fuhrman Pleural and Pneumopericardial Drainage Sets because the catheter may break during insertion. The company has received two reports that the catheter included in the drainage set broke off in the pleural cavity while inserting the device into the patient, according
Drugs
FDA commissioner-nominee Robert Califf says that revising advertising and promotion policies and the agency’s approach to foreign inspections will be top priorities if he is confirmed as the next commissioner. The Senate HELP Committee is scheduled to vote on his nomination 1/12. In response to questions posed
Devices
FDA has cleared a K2M Group Holdings 510(k) for the Cascadia Lateral Interbody System featuring Lamellar Titanium Technology that uses 3D printing with the goal of allowing for bony integration throughout the spinal implant. “Starting with a titanium powder, the implants are grown through the selective application of a
Drugs
FDA commissioner nominee Robert Califf says improving clinical trial designs to understand the effects of new drugs and devices in patient subpopulations is a high priority for the agency and it will “require a comprehensive, multifaceted approach using a concept known as ‘quality by design.’” Responding to follow-up questions
Devices
FDA has granted approval of a new indication for Integra LifeSciences’ Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers that last for longer than six weeks and do not involve exposure of the joint capsule, tendon or bone, when used in conjunction with standard diabetic ulcer care. The
Devices
Novocure has filed a PMA supplement for its second generation Optune system for treating glioblastoma patients. The portable device is designed to deliver “Tumor Treating Fields” (TTFields) therapy to patients with newly diagnosed and recurrent glioblastoma. Novocure says it designed the second generation system to improve the convenience and manageability
Devices
An amendment from Rep. Mike Fitzpatrick (R-PA) to overturn the U.S. Supreme Court’s landmark Riegel v. Medtronic decision and allow patients harmed by a PMA device to seek the same redress as anyone else in the courts was rejected 1/6 after it was ruled not germane
Devices
Drager has begun a Class 1 recall of the PS500 battery power supply for its Evita V500 and Babylog VN500 Ventilators because a software issue causes shorter than expected battery run times. The software bug also prevents the appropriate alarm from sounding five minutes before the battery depletes its power
Drugs
While in a few cases genetic information has proved useful in screening and treating diseases, in general the broad application of genetic information has not yet been shown to be helpful, despite considerable hype suggesting imminent and overwhelming benefits. That’s the conclusion reached in a CardioBrief analysis of a
Devices
Are there alternative FDA regulatory approaches that could accelerate hearing aid device innovation? Current hearing aids on the market are notorious under-performers, so innovation in the technology is what the agency wants to explore at a 4/21 public workshop on “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.
Devices
Rep. Mike Fitzpatrick (R-PA), who has been championing relief measures for patients injured by power morcellators and Bayer’s Essure permanent birth control device, has introduced an amendment that would overturn the U.S. Supreme Court’s landmark Riegel v. Medtronic decision and allow patients harmed by a PMA
Devices
CDRH has published lists of guidance documents that it intends to publish in FY 2016 and previously-issued final guidances for which it wants to receive external feedback on whether they should be revised or withdrawn. There are two lists of guidances the Center wants to issue — an “A-list”
Devices
NBC News says confidential C.R. Bard records it obtained show that the company replaced a blood clot filter associated with 27 deaths and hundreds of problems with a modified version that it knew had similar and potentially fatal flaws soon after it was put on the market. The news
Devices
An 8/24-8/27/15 FDA inspection at the Sorin Group manufacturing facility in Munchen, Germany, identified Quality System Regulation and other violations in the firm’s manufacturing of Stockert Heater Cooler 3T thermal regulator devices. A 12/29/13 Warning Letter says that specific violations noted on an
Devices
FDA has issued a medical device safety communication urging healthcare providers in Puerto Rico and staff at healthcare facilities or hospitals in Puerto Rico not to use Customed convenience packs and trays for any surgical procedures. The notice says that the integrity, safety and efficacy of the products can’t
Devices
Lanx, Inc., a spinal fixation device maker, won a product liability case in Mississippi last month by relying upon, among other defense arguments, the Buckman U.S. Supreme Court decision on federal preemption. In Estes v. Lanx, Inc., plaintiff Rocky Estes underwent spinal fusion surgery in 2011 that used the
Devices
FDA has reclassified from Class 2 to Class 3 surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The agency is also requiring these product manufacturers to now submit a PMA to support their device’s safety and effectiveness. “The orders will require manufacturers to address
Devices
A draft guidance on “Unique Device Identification (UDI): Convenience Kits” outlines a narrower interpretation of convenience kits that are exempt from bearing UDIs on the individual components. Under FDA’s 2013 UDI final rule, devices packaged within the immediate container of a convenience kit are excepted from UDI labeling requirements