Healthcare Watch March 2015

Med Device: Clear Images Without The Radiation


When serious injuries or health risks are suspected, doctors usually order a Computed Tomography Scan, better known a CT scan, which provide images of the body through a narrow beam of X-rays that are then processed into 3D images.

In 2013, GE took it a step further by unveiling the Revolution CT, a super-fast scanner that allows physicians to obtain clear images of the heart, lungs and other vital organs in real time. The scanner uses a combination of low dose exposure, organ-wide coverage and motion correction technology, which allows doctors to reduce the patient’s exposure to radiation while obtaining high-resolution images of the body.

Since September 2014 the device has been used exclusively at the West Kendall Baptist Hospital in Florida during a six-month clinical trial. Doctors who used the device during the recently completed trial revealed that they were able to diagnose even the most challenging cardiac patients and reduce radiation exposure for pediatric patients.

According to West Kendall Baptist Hospital CEO, Javier Hernández-Lichtl, “The advanced design definitely makes for a less intimidating, more comfortable patient experience, while yielding amazingly accurate and detailed images.”

Trend Setting: FDA Approval Times Improving

According to a report from PricewaterhouseCoopers (PWC) titled The FDA and Industry: A Recipe for Collaborating in the New Health Economy, the FDA is making strides to improve and expedite the approval process of drug and medical devices.

As of 2012, the FDA has managed to approve pre-market approval applications (PMAs) in seven months—half the time it took three years earlier. In addition to expedited PMAs, the process of reviewing new drug applications (NDAs) and biologics licensing applications (BLAs) saw an improvement from 13 months to 10 months between 2008 and 2012.

However, priority reviews, which are actually intended to accelerate the assessment of products, have not seen the same steady improvement as the standard review process. Priority review for devices went from six months in 2008 to 16 months in 2009, before going down to eight months in 2012—still lacking from the average approval times achieved four years earlier. Drugs have fared better: The process has improved from 11 months in 2008 to six months in 2012.

Doctor Docs: Who Pays The Most For Doctors?

Most people think that entering the medical profession in major medical hubs such as Boston or San Francisco will result in high-paying, prestigious medical careers. Though this is true to some degree, as it turns out, according to Doximity’s Career Navigator, doctors who practice medicine in rural areas such as Montana and South Dakota actually earn more than those who work in major cities.

When members of Doximity crunched the numbers they showed that doctors who work in more trendy areas on average make $1,500 less a year than doctors who work in rural areas. Though this seems unlikely, it comes down to simple economics—supply and demand. Lauren Lloyd, a spokeswoman for Doximity, told MedCity News that while the demand for doctors in rural areas stays consistent, the supply of doctors in rural areas tends to be lower. So, as a result, physicians are being paid higher wages in these areas to keep up with the demand.

Discoveries/Innovations: A Cure For Paralysis?


Astonishing developments are on the horizon for those paralyzed due to spinal cord injuries. Scientists at École Polytechnique Fédérale de Lausanne (EPFL), a research institution in Switzerland, developed e-Dura, a spinal cord implant that could help paralyzed individuals walk on their own again, through electrical and chemical stimulation.

In a study, EPFL scientists successfully managed to get rats to walk on their own with the use of the technology. But for humans, there could still be an issue. The multi-functional device would be a long-term implant on the spinal cord, which could cause tissue damage.

The implant was designed to mimic living tissue, so that when it is implanted on the surface of the spinal cord—beneath the nervous system’s protective envelope known as the “dura mater”—its elasticity and potential for deformation would limit any inflammation. So far, the tests on rats revealed neither tissue damage nor rejection after two months.

The researchers are planning to move onto clinical trials in humans, and eventually the development of a commercialized prototype. They believe this device also has the potential to help those suffering from epilepsy and Parkinson’s disease and to aid in pain management.

TeleMed Texts: Needle-free Way To Monitor Glucose


Nanoengineers at the University of California, San Diego tested a temporary tattoo that can extract and measure glucose levels in the fluid between skin cells. The cost-effective, easy to wear flexible technology is a first-ever example of its kind. The device is made up of carefully patterned electrodes on temporary tattoo paper and applies a mild electrical current to the skin that forces sodium ions to migrate to the electrode. The built-in sensor then measures the glucose found in these molecules.

The “proof-of-concept” tattoo was developed and tested at the Jacobs School of Engineering at UC San Diego by graduate student Amay Bandodkar and colleagues. The device could provide an opportunity to not only test glucose levels but also other metabolites in the body as well. Eventually the team plans on having the device offer numerical read outs, with Bluetooth capabilities so the patient’s information may be sent directly to their doctor in real time.

FDA Update

Drug Approvals

NanoSmart Pharmaceuticals received Orphan Drug Designation for an antinuclear antibody (ANA) conjugated liposomal doxorubicin that is intended for the treatment of Ewing’s sarcoma.

Cohera Medical has received approval for its internal surgical adhesive TissuGlu, which connects tissue flaps following major abdominal surgery.

Novartis’ Farydak (panobinostat) is the first histone deacetylases (HDACs) inhibitor approved to treat multiple myeloma. This new process has been shown to slow the slow the progression of multiple myeloma.

Priority Review

PharmaMar has been granted priority review for Yondelis, a treatment for patients diagnosed with soft tissue sarcoma (STS). PharmaMar’s strategic partner, Janssen Research & Development, will promote the drug in the U.S.

New Devices

The FDA approved Koning Corporation’s Koning Breast CT (KBCT) system and KBCT-guided biopsy bracket. KBCT is the first ever commercially available 3D breast scanner that produces 3D images in a single scan in a matter of seconds, with excellent patient comfort and lower radiation exposure.

Velano Vascular received marketing clearance for their innovative approach to drawing blood in a hospital setting. The Velano Vascular technology reduces the need for needle pricks when drawing blood, reducing the anxiety some patients experience when receiving intravenous medications and hydration.


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