Engility Holdings said today it won a 5-year, $112 million indefinite delivery/indefinite quantity contract with the FDA’s Scientific Computing Board and Office of Information Management and Technology. Through the contract, Chantilly, Va.-based Engility will supply computational science and bioinformatics services to the FDA, looking to support gene-based drug discovery and development. “With this award, Engility […]
Food & Drug Administration (FDA)
Medtronic wins FDA nod for CoreValve Evolut TAVR system
Medtronic (NYSE:MDT) said today it won FDA approval for its CoreValve Evolut R 34mm transcatheter aortic valve replacement system, touting it as the largest sized TAVR system available in the U.S. The Fridley, Minn.-based company said the system is cleared for use in patients with severe aortic stenosis and who are at high or extreme risk […]
FDA updates warning on SynCardia drivers
SynCardia Systems today released an update on issues with its Temporary Total Artificial Heart’s Companion 2 driver system and released information on neurological adverse event issues with its pneumatic Freedom driver system. A post-approval study in June 2015 indicated a higher mortality rate for a subgroup of patients using SynCardia’s TAH-t C2 driver system compared with […]
Spineology wins FDA 510(k) for Rampart Duo interbody fusion device
Spinal tech developer Spineology said today it won FDA 510(k) clearance for its Rampart Duo interbody fusion system. The St. Paul, Minn.-based company said its newly-cleared Rampart Duo is the 1st device of its kind to combine PEEK, titanium and graft containment mesh elements. “Rampart Duo is an innovative interbody fusion device that builds upon Spineology’s OptiMesh […]
Johnson & Johnson’s Ethicon wins FDA nod for expanded Evarrest indication
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it won an expanded indication from the FDA for its Evarrest fibrin sealant patch, now cleared for use as an adjunctive hemostat across a “broad range” of challenging patient types and surgical situations. The company touted the win as a significant milestone in controlling problematic bleeding situations “with high confidence.” “I’m […]
Targazyme wins FDA clearance for Phase II bone marrow stem cell study
Targazyme said today that it will begin enrolling patients in a Phase II clinical study to evaluate TZ101-fucosylated bone marrow stem cells in cancer patients, after the FDA granted the San Diego-based company investigational new drug clearance. The treatment is designed to use blood-forming stem cells from bone marrow to restore the body’s ability to make blood […]
FDA puts Acclarent’s Aera Eustachian tube balloon in Class II
The FDA today said it reclassified Johnson & Johnson (NYSE:JNJ) subsidiary Acclarent’s Aera Eustachian tube balloon to a Class II device. The Irvine, Calif.-based company’s Aera system consists of a balloon catheter designed to be inserted through the patient’s nose into the Eustachian tube. After insertion, the balloon is inflated to open up a pathway for mucus and […]
FDA, CMS extend parallel review program indefinitely
The FDA and Centers for Medicare & Medicaid Services said today that the Parallel Review of Medical Devices pilot program will be fully implemented and extended indefinitely. The program from the FDA is a collaborative effort “intended to reduce the time between FDA marketing approval or FDA’s granting of a de novo request and Medicare […]
aTyr Pharma wins FDA Fast Track Designation for muscular dystrophy therapy
aTyr Pharma (NSDQ:LIFE) said today that its candidate Resolaris was granted fast track designation by the FDA for the treatment of facioscapulohumeral muscular dystrophy, making it the 1st therapeutic candidate to receive the designation for the rare form of muscular dystrophy. Resolaris is derived from a naturally occurring protein released by human skeletal muscle cells. aTyr is […]
FDA delays Inovio phase III trial of DNA immunotherapy candidate
Inovio Pharmaceuticals (NSDQ:INO) said today that the FDA placed a hold on its proposed Phase III clinical program for its investigational DNA immunotherapy candidate designed to treat pre-cancers and cancers caused by human papillomavirus. The California-based company completed a randomized, double-blind Phase II trial of the candidate in July 2014, evaluating the DNA immunotherapy treatment in women […]
Medtronic wins FDA nod for lower-profile HawkOne atherectomy device
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for a new lower profile version of its HawkOne directional atherectomy system, designed for treating patients with peripheral artery disease. The Fridley, Minn.-based company’s HawkOne is a directional atherectomy device designed to treat severely calcified lesions in the blood vessels of the lower extremities. The device […]