Tag Archives: FDA

List of Top 10 Biomedical Innovations for 2013

Top 10 2013A handheld optical scanner to detect skin cancer, “bladeless” cataract surgery, and an amazing new headache treatment are among the Top 10 Medical Innovations for 2013 selected by a panel of Cleveland Clinic scientists and researchers.

A surprising government program also made the list, unveiled at the clinic’s Medical Innovation Summit. To qualify, a breakthrough had to offer a major improvement in patient care, have a high probability of success, and must either be on the market now or be close to being introduced.

Here’s a look at the remarkable therapies and game-changing technologies expected to dramatically reshape healthcare—and save lives—over the next year:  

First Retinal Prosthesis under FDA Approval

FDA reviewers expressed concern over the long-term safety of what could be the first retinal prosthesis device despite evidence that it helps improve the vision of some nearly blind patients.

Members of the FDA’s Medical Devices Advisory Committee will vote Friday on whether to recommend approval of the Argus II Retinal Prosthesis device. Members of the ophthalmic panel also will discuss and recommend possible post-approval study requirements should the device ultimately gain FDA clearance.

The Argus II is designed for use by patients with severe to profound retinitis pigmentosa, who experience progressive vision loss, often leading to blindness.

Biomedical Devices getting Unique ID’s in USA to track safety

English: Logo of the .

English: Logo of the . (Photo credit: Wikipedia)

Medical devices like hip implants and heart defibrillators will soon join the ranks of cars and toasters.

The Food and Drug Administration on Tuesday proposed a new rule that would require each medical device to have a unique code that could improve tracking and catch safety problems earlier. The proposal comes five years after Congress first mandated the codes.

While these codes are already present for most consumer goods, in the ubiquitous barcodes scanned at the grocery store, they have been absent from life-sustaining medical devices.

Innovations in Medical Sensors for Biomedical Electronics Applications in Healthcare

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Biomedical electronics research is being driven by the aging “baby-boomer” population and their medical needs. This phenomenon is spurring fast development of new biotechnologies and need for access to innovative means of medical diagnosis and treatment in preventive medicine. Subsequently, the technologies of implants and advanced wireless electronic media will help alleviate rising medical costs in today’s society and extend the average longevity with a quality life in our later years.