Archive for the ‘FDA’ Category

Konica Minolta has received FDA clearance to market its Aero DR wireless flat panel radiography detector.  The 17 x 17 inch device weighs about 8 pounds (3.6 Kg).  The device is focused around a Cesium Iodide (CsI) scintillator that promises high detector quantum efficiency (DQE). These detectors also take advantage of Konica Minolta’s very low power ... Full story

The FDA granted pre-market approval to St. Jude Medical for the company’s Therapy Cool Path Duo and Safire Blu Duo cardiac ablation catheters and the matching IBI1500T9-CP V1.6 generator to power them. The catheters provide cooling irrigation all around the tip from a dozen ports so that only targeted tissue is destroyed.  The system is already ... Full story

It’s been implanted in Europe and other places outside the U.S. for over a decade, and the company says that the implant can deliver lower wear and dislocation rates when compared to competing devices. The system is specifically designed to address the challenges of treating patients – in both primary and revision cases – who are ... Full story

Integra LifeSciences recently announced the launch of the Integra Allograft Wedge System, their pre-cut allograft wedges for Evans and Cotton osteotomies. Osteotomies are procedures in which bone is cut and then re-aligned, often with new bone placed as a wedge to secure the new position. The Cotton osteotomy involves the medial cuneiform and is used to correct rotational deformities of the forefoot. The Evans osteotomy, ... Full story

Medasys has received FDA pre-market approval for its Prometra programmable implantable drug pump. The Prometra is a non-peristaltic programmable implantable pump that delivers INFUMORPH (preservative-free morphine sulfate sterile solution) intrathecally for the management of pain. The Prometra makes use of a valve gated precision dosing system to achieve high accuracy, minimizing dose variations due to temperature, ... Full story

FutureMed featured back-to-back sessions from Paul Grundy, MD and Watson guru Marty Kohn, MD. We’ll give you a rundown of both of their presentations here: Paul Grundy, MD, IBM’s global director of healthcare transformation, is a proponent of a primary-care model called the “Patient Centered Medical Home.” Dr. Grundy explained that he developed the model by ... Full story

The U.S. Army has been trying to improve first aid medical response of soldiers in the field, and has developed the latest Individual First Aid Kit, or IFAK, to meet the unique needs that presented themselves in Iraq and Afghanistan. But the IFAK is bulky and gets in the way of other ... Full story

Toshiba has received FDA clearance for their Aquilion PRIME CT system. The scanner uses many of the features developed for the Aquilion ONE, and focuses on low radiation dose and a fast workflow. Compared to the Aquilion ONE it has fewer detector rows (80 vs. 320) and a shorter coverage area, but it does add two ... Full story

InterVapor, from Uptake Medical (Tustin, CA), is a non-surgical endoscopic lung volume reduction procedure that uses thermal ablation without leaving foreign materials in the lung. In clinical studies of patients with severe emphysema, InterVapor has demonstrated clinically meaningful improvements in breathing function, exercise capacity and quality of life. The company has now closed a Series C funding round, which will support commercialization of InterVapor for treatment ... Full story

Electronic cigarettes have become a big business as many smokers have opted to choose them over the traditional variety. Lack of actual smoke and tar is a major positive, but being able to “smoke” them even where smoking is not allowed may lead to a greater overall intake of nicotine. Nevertheless, many people bought e-cigarettes as a smoking cessation tool that takes away some of ... Full story