TriVascular has announced the initiation of a U.S. Post-Approval Study (PAS) of the Ovation Prime Abdominal Stent Graft System for the treatment of abdominal aortic aneurysms (AAA).
Heart tissue sustains irreparable damage in the wake of a heart attack. Because cells in the heart cannot multiply and the cardiac muscle contains few stem cells, the tissue is unable to repair itself — it becomes fibrotic and cannot contract properly.
A researcher from Imperial College London and his colleagues have developed for the first time a map of a typical bird brain, showing how different regions are connected together to process information.
Researchers have developed a drug delivery technique for diabetes treatment in which a sponge-like material surrounds an insulin core. The sponge expands and contracts in response to blood sugar levels to release insulin as needed. The technique could also be used for targeted drug delivery to cancer cells.
CAZ Investments raised a nearly $29 million funding round it plans to use to back medical companies that already have products on the market. The Houston-based asset management firm reeled in $28.7 million from 61 unnamed investors, according to a regulatory filing.
Ottawa-based Nordion unloaded its targeted therapy business, handing the division, related products and about 40 employees over to British life sciences company BTG plc for $200 million. BTG will take over the division's lone product, an increasingly lucrative targeted liver cancer therapy system called TheraSphere.
There's a bit of a domino effect undercutting President Barack Obama's health care law. Enforcement of the overhaul's central mandate — that individual Americans must have coverage — could be weakened by the Obama administration's recent delay of a requirement that larger employers provide medical insurance.
Abbott missed expectations with its 2nd-quarter sales but still managed to exceed earnings forecasts, sending shares up this morning on Wall Street. The Chicago-area company posted profits of $476 million, or 64¢ per share, on sales of $5.45 billion during the 3 months ended June 30, for sales growth of 2.5% but a bottom-line slide of 72.4%.
Flowonix Medical has announced that initial patients implanted during the clinical study with the Prometra implantable intrathecal drug pump have reached over six years of device longevity. The Prometra pump is projected to provide a minimum of 10 years of service, with projected longevity of about 13 years at flow rate settings of 0.25 mL per day or lower.
Synthetic implant company Cartiva closed a $4.3 million financing round led by venture capital firm New Enterprise Associates. As part of the round, 1 of the VC firm's partners, Dr. Justin Klein, will join Cartiva's board of directors. The Alpharetta, Ga.-based device maker plans to use the funds to support trials for its synthetic cartilage implant for treatment of arthritis in the big toe.
Covidien kicked off 2 new clinical trials this week to support a global evaluation of its Stellarex drug-coated angioplasty balloon. The Massachusetts-based company started enrolling patients with peripheral arterial disease in the Pivotal and PK arms of its larger ILLUMENATE clinical trials examining the safety and effectiveness of Covidien's Stellarex devices.
Cell therapies may stop or reverse the pain and disability of degenerative disc disease and the loss of material between vertebrae, according to Duke University scientists. The health conditions affect thousands of Americans.
Researchers at Johns Hopkins have coaxed stem cells into forming networks of new blood vessels in the laboratory, then successfully transplanted them into mice. The stem cells are made by reprogramming ordinary cells, so the new technique could potentially be used to make blood vessels genetically matched to individual patients and unlikely to be rejected by their immune systems, the investigators say.
Disagreements are inevitable in science, medicine – and even life. As part of a regulatory agency committed to public health, the FDA's medical devices center occasionally confronts scientific and policy disagreements among our staff and with the various stakeholders we strive to serve.
Doctors have a new way of thinking about how to treat heart and skeletal muscle diseases. Body builders have a new way of thinking about how they maximize their power. Both owe their new insight to high-energy X-rays, a moth, and cloud computing.