Articles by Chuck Seegert

31. Improving Clinical Trials Remains Top FDA Priority 1/25/2015

    To address concerns about lengthy approval times for clinical trials, the FDA has re-committed itself to strengthening and streamlining the complex process. Improving clinical trials is reportedly one of the top three strategic priorities of the FDA’s Center for Devices and Radiological Health (CDRH) for 2015.

32. Could Ventricular Assist Devices Help Cure Heart Failure? 1/23/2015

    Recent cutting-edge research has shown that left ventricular assist devices may help regenerate heart tissue. Prolonged use of these devices cuts down on certain forms of oxidative cell damage, enabling significant cardiac cell proliferation in humans.

33. FDA Releases Draft Guidance On Medical Device Accessories 1/23/2015

    The FDA has recently released draft guidance related to medical device accessories, which includes how those products are defined. Classification of these devices uses a risk-based framework, and the guidance describes the process for identifying where an accessory fits within that framework. The document was only released to elicit comments from industry and other parties, and is not final or in effect at this time.

34. Immobile Sperm Cells Swim Again Thanks To Light 1/22/2015

    For the first time, the function of sperm has been controlled by optogenetic processes. By inserting a light-activated enzyme into mouse sperm, researchers from the Max Planck Society turned previously sterile mice into fertile ones. This work illustrates how optogenetics can be used outside the area of neuronal cell research.

35. Portable Stimulator Could Improve Balance, Motor Skills Of Parkinson's Patients 1/22/2015

    New research has shown that a small electronic unit may help restore balance to patients suffering from Parkinson’s disease by applying electric noise stimulation. The device provides electrical stimulation to the organs that monitor balance, which compensates for shortages of dopamine and restores motor skills and balance. Originally tried in rats, the technique has now shown some benefit in humans.

36. New Laser Could Significantly Improve Biomedical Imaging 1/22/2015

    Yale researchers have developed a new semiconductor laser that could advance imaging quality across a broad range of applications. Designed around chaotic cavity laser activity, the device eliminates image corruption. It provides the brightness of traditional lasers and the low image corruption of light-emitting diodes, which could enable next-generation microscopes, photolithography, and biomedical imaging.

37. Wearable Sensor Could Provide Long-Term EKG, EMG Monitoring 1/22/2015

    A new wearable sensor based on silver nanowires has been developed by North Carolina State University researchers. The sensors are designed to monitor electrophysiological signals and could be used to monitor electrocardiographs (EKGs) and electromyographs (EMGs) — even when a patient is in motion.

38. FDA Releases Draft Guidance On General Wellness Products 1/21/2015

    The FDA recently released draft guidance related to products that promote a healthy lifestyle. The guidelines were released to clarify what low-risk devices fit into the category of “general wellness products.” The document was only released to elicit comments, and is not final or in effect at this time.

39. “Clinic-In-A-Box” Could Provide Rapid Diagnoses 1/20/2015

    With a single drop of blood and a few minutes time, a new diagnostic system could detect a wide range of diseases. The “clinic-in-a-box” combines immunoassays, clinical chemistry, and more into a single diagnostic platform that could be used while a patient waits in the doctor’s office. Developed by an Irish company called Radisens Diagnostics, the test is also being looked at by the European Space Agency.

40. J&J To Publicly Release Clinical Trial Data On Medical Devices, Diagnostics 1/20/2015

    Johnson and Johnson recently revealed plans to systematically make its medical device and diagnostic test clinical trial data available to the public, making it the first large medical device manufacturer to undertake this level of transparency. The healthcare giant will work with Yale University’s Open Data Access program.