Essay Preview: LawReport this essayFor More Information:Kimberly Goolsby(949) [email protected] IMMEDIATE RELEASEFDA APPROVES REFRACTECs® CKSM (Conductive KeratoplastySM)NON-LASER PROCEDURE FOR FARSIGHTEDNESSCK Uses Radiofrequency Energy, Instead of a Laser, to Reshape the CorneaWithout Cutting or Removing TissueIRVINE, Calif., April 16, 2002 – Ophthalmic device manufacturer Refractec Inc. today announced that the U.S. Food and Drug Administration has approved CK (Conductive Keratoplasty), a procedure for farsightedness (hyperopia) in people over age 40. CK utilizes the controlled release of radiofrequency (RF) energy, instead of a laser or scalpel, to reshape the cornea. The minimally invasive CK procedure takes less than three minutes and is done in-office with only topical (eye drop) anesthesia.
FDA APPROVES REFRACTECs® CK (Conductive Keratoplasty)NON-LASER TECHNOLOGIESIS REQUESTEDFOR C-SPARSAF RECOGNITION This story was edited at 9:17 AM.
Electronic Cigarettes
This story was edited at 9:27 AM.
Computer/Machine Interface: the Science of Computers, May 21, 2008: “The New Computational Model” by Bruce Anderson, PhD, Director, Institute for Computational Biology (ICB) at Purdue University, “The new models for the management of the human body, including the human brain, and the brain’s use for self-management and medical applications are very promising in their ability to enable us to apply new technology to health care. However, the physical differences between human and computer models of the human brain that will be analyzed in this series of four open-access journal articles will be of tremendous importance to current and future research on the use of electronic devices for health care.”
“This new modeling model is called what are known as an e-ink. These are non-invasive, low-cost technologies that are based on an integrated computational and non-invasive imaging procedure that uses nanoscale computer chips in the brain. These devices enable us to generate a synthetic version of a physical device such as a mouse which is able to recognize humans (by mimicking a mouse’s behavior).”
“This model incorporates the techniques of computer architecture and computing through physical simulation technologies that have been utilized in computer and other industries for more than 40 years. In this study, we report on the study of the current role of computers in human health care, including the role of e-ink design technologies. We show that e-ink design processes, such as the human neuroendocrine and blood-brain pathways, reduce the risk of human disease in some patients. We demonstrate the effectiveness of an e-ink model that is based on computational and biological simulations of the human brain using the latest nanoscale electronic technology and show that the device can be made to accept changes to the target tissue or the target organ. The results imply that the most promising new e-ink design approaches are based on models developed for use in human biomedical applications or in non-invasive devices using materials and systems that are novel as well as novel byproducts of the human brain.”
A review by the journal Proceedings of the National Academy of Sciences summarizes the critical role that e-ink design technologies can play in health care:
“This new biological model of the human body that has evolved from micro-organismal biology to tissue engineering, the “e-ink,” emphasizes the inherent similarities to the human brain and its human body structures:
This model is based on computationally intensive, low-cost computer architectures that can take advantage of the ability of electronic devices to recognize human movement and
FDA APPROVES REFRACTECs® CK (Conductive Keratoplasty)NON-LASER TECHNOLOGIESIS REQUESTEDFOR C-SPARSAF RECOGNITION This story was edited at 9:17 AM.
Electronic Cigarettes
This story was edited at 9:27 AM.
Computer/Machine Interface: the Science of Computers, May 21, 2008: “The New Computational Model” by Bruce Anderson, PhD, Director, Institute for Computational Biology (ICB) at Purdue University, “The new models for the management of the human body, including the human brain, and the brain’s use for self-management and medical applications are very promising in their ability to enable us to apply new technology to health care. However, the physical differences between human and computer models of the human brain that will be analyzed in this series of four open-access journal articles will be of tremendous importance to current and future research on the use of electronic devices for health care.”
“This new modeling model is called what are known as an e-ink. These are non-invasive, low-cost technologies that are based on an integrated computational and non-invasive imaging procedure that uses nanoscale computer chips in the brain. These devices enable us to generate a synthetic version of a physical device such as a mouse which is able to recognize humans (by mimicking a mouse’s behavior).”
“This model incorporates the techniques of computer architecture and computing through physical simulation technologies that have been utilized in computer and other industries for more than 40 years. In this study, we report on the study of the current role of computers in human health care, including the role of e-ink design technologies. We show that e-ink design processes, such as the human neuroendocrine and blood-brain pathways, reduce the risk of human disease in some patients. We demonstrate the effectiveness of an e-ink model that is based on computational and biological simulations of the human brain using the latest nanoscale electronic technology and show that the device can be made to accept changes to the target tissue or the target organ. The results imply that the most promising new e-ink design approaches are based on models developed for use in human biomedical applications or in non-invasive devices using materials and systems that are novel as well as novel byproducts of the human brain.”
A review by the journal Proceedings of the National Academy of Sciences summarizes the critical role that e-ink design technologies can play in health care:
“This new biological model of the human body that has evolved from micro-organismal biology to tissue engineering, the “e-ink,” emphasizes the inherent similarities to the human brain and its human body structures:
This model is based on computationally intensive, low-cost computer architectures that can take advantage of the ability of electronic devices to recognize human movement and
Farsightedness, which occurs when the cornea is too flat or the eye is too short, is the most common vision disorder in America and affects more than 60 million people over age 40. Symptoms include difficulty reading menus, a computer screen and seeing to drive at night, or the need to constantly reposition reading material to find the right focus.
“For years, the farsighted have been left behind as vision correction progressed: RK (radial keratonomy), PRK (photorefractive keratectomy) even LASIK (Laser In-situ Keratomileusis) initially, were all treatments designed specifically for the nearsighted,” said world-renowned ophthalmologist Marguerite B. McDonald, MD, medical monitor for the FDA clinical trials, director of the Southern Vision Institute and clinical professor of ophthalmology at Tulane University, New Orleans, La. “CK is one of the first procedures designed specifically for the millions of people with hyperopia.”
(more)FDA Approves CKDue to the flatness of the cornea, farsightedness is the most difficult disorder to treat with LASIK and the most likely to cause complications, according to Robert K. Maloney, MD, principal FDA clinical investigator and director of the Maloney-Seibel Vision Institute in Santa Monica, Calif.
“Hyperopic LASIK accounts for about 20 percent of my practice, but 80 percent of the complications, because hyperopic patients are more likely, after LASIK, to get dry eyes, hazy vision or poor quality of vision,” said Dr. Maloney.
Procedure Appeals to Risk-Adverse Baby BoomersBaby Boomers (those born between 1946 and 1964) comprise the largest segment of the farsighted population, and many view the need for glasses as a sign of aging. Yet, hyperopic procedures comprised only a small percentage of the nearly 2 million U.S. refractive surgeries performed last year. Consumer research indicates that, to date, very few people between the ages of 40 to 60 have even considered vision correction surgery, as they tend to be more conservative and risk-adverse than their younger, nearsighted (myopic) counterparts.
“CK meets the needs of the risk-adverse patient population, those whove been waiting for a safe, less-invasive treatment for farsightedness,” said Dr. Maloney. “As the first approved alternative to a laser for treating hyperopia, its a very effective procedure and most of all, the patients love it. Its quick. Theres very little post-op discomfort and immediate return of vision.”
About the CK ProcedureCKSM can change how the eye focuses light by reshaping the cornea. CK uses a controlled release of radiofrequency energy to heat and shrink the corneal tissue, which steepens the cornea. This steepening results in the desired refractive effect.
(more)FDA Approves CK“In the CK procedure we apply radiofrequency energy to the eye through a tiny probe as thin as a human hair,” said Dr. Maloney. “We apply this energy in a circle and it causes constriction, almost like tightening a belt, which increases the curvature of the eye to treat farsightedness.”
The use of RF energy is one of todays most advanced surgical techniques. In addition to its use in CK, RF technology is being used in prostate cancer therapy, back surgery, even cardiovascular procedures.”
“During the CK Clinical Trials everybody we treated had an improvement in vision,” said Dr. McDonald. “And its safe – incredibly safe. Thats due to the fact that these radiofrequency waves do not remove any tissue from the eye, theres no cutting and that, we think, makes it a very attractive option for millions of patients.”
The Refractec Viewpoint™ CK System received premarket approval for the temporary reduction of spherical hyperopia in patients who have 0.75 D to 3.25 D of cyclopegic spherical hyperopia, with less than or equal to 0.75 D of refractive astigmatism (minus cylinder format), and a cyclopegic spherical equivalent of 0.75 D to 3.00 D. Patients must be 40 years of age or greater with a documented stability of refraction for the prior 12 months, as demonstrated by a change