This is a Migraine zapper gadget. It is a hand-held device. It is shaped like a large brick connecting with a handle. It emanates strong but lower frequency magnetic pulses. It may decrease the pain due to migraine if used backside of head. Patients, suffering from Migraine may use it without anybody’s help. A previous research had reported that the use of transcranial magnetic stimulator (TMS) reduces or the device completely controls the pain. It may be useful in severe depression, posttraumatic stress syndrome and in tinnitus too. The US Food and Drug Administration is supposed to grant approval this TMS technology device for the patients suffering from migraine and depression.
Food and Drug Administration (FDA) has approved a gadget that is the urgent PC Neuromodulation System from Uroplasty Inc. It motivates the tibial nerve in just a thirty-minute session only. This treatment is effective when the conventional therapy fails. This device is easy to use for doctors. Some of minimal side effects such as include redness or discomfort at the treatment site is reported. This device is used in the treatment of overactive bladder and Faecal Incontinence.
Medtronic Inc. announced that the U.S. Food and Drug Administration (FDA) have granted an investigational device exemption (IDE) to the DIAM Spinal Stabilization System for use in a clinical study. Medtronic will be the first of three planned clinical trials in the U.S. and Europe. The DIAM System is designed to alleviate pain in degenerative stenosis patients. They suffer from radiating leg discomfort and moderate low back pain. The initial Medtronic study will look for the safety and efficacy of the DIAM System after using to treat patients with degenerative stenosis. Degenerative stenosis becomes noticeable by the gradual narrowing of the spinal canal, which results in pressure on the spinal cord or nerve roots. The purpose of decompression surgery is to release excess pressure by creating more space in the spinal canal. Combined with decompression, the DIAM System could offer patients with leg and back pain a minimally invasive alternative to spinal fusion.
SmartPill pH.p Capsule developed by SmartPill Corp. has got FDA’s approval. The capsule, which is a wireless, indigestible medical device, can be swallowed like any ordinary vitamin pill to determine the medical pressure, gastric emptying time (gastroparesis) and total transit time. When the capsule passes through the gastrointestinal tract, it collects all the data and sends it to the receiver that is tied to the patient’s belt. When the single use SmartPill is excreted from the body, all the information can be downloaded from the SmartPill Data Receiver.
Smith & Nephew’s Orthopaedic Trauma & Clinical Therapies has got the green signal from FDA for its EXOGEN 4000+* Bone Healing System. The EXOGEN 4000+ Bone Healing System is a low-intensity pulsed ultrasound device that is externally applied 20 minutes a day over the site of a broken bone. It is the ONLY bone stimulator that uses ultrasound technology to heal the fractures faster than earlier. Ken Reali, vice president and general manager, Orthopaedic Clinical Therapies, said: Receiving FDA approval for the EXOGEN 4000+ Bone Healing System is yet another win for surgeons and patients. While the accelerated healing potential and non-union treatment capabilities of the system continue to provide the same non-invasive alternative to surgery, the design upgrades make it easier to operate further optimizing patient care. The EXOGEN 4000+ Bone Healing System will hit the market by the end of 2006 and will substitute the EXOGEN 2000+*.
Milestone Scientific Inc. in New Jersey, renowned for developing dental devices, has got FDA thumbs up for its CompuFlo™, a computer controlled local anesthesia infusion pump, CompuFlo(TM). PRnewswire reports that the company calls it an “‘intelligent’ computer controlled local anesthetic delivery system”. The dentist community has already welcomed the predecessor, CompuDent. It gave local anesthetic injections of all types by holding the Wand(TM) that gives you a palpable control without the muscle fatigue. The CompuFlo Computer Controlled Infusion Pump utilizes pressure feedback data to observe and control the release of local anesthesia, medications and other fluids to the patients. Thomas Ronca, President and Chief Operating Officer of the Company said: Clinical studies using Milestone’s CompuFlo Computer Controlled Infusion Pump in the administration of epidural anesthesia have provided highly encouraging results. We believe that, because of the risks associated with current epidural injection techniques, CompuFlo has the potential to become a ‘standard of care’ within the anesthesiology profession. Our next step is to identify and enter into strategic relationships with one or more marketing leaders in the medical device field. FDA has accepted the CompuFlo(TM). Now we have to see whether the dental community accepts the product or not.
Spire Corporation has got FDA thumbs up for its new Silver Coated Hemodialysis Catheters. The company claims that the lubricious silver coating, nanocrystalline can reduce bacterial colonization for up to two months on its long-term dialysis catheters. The coating will be offered on Spire’s XpressO(R) and RetrO(R) silicone catheter lines under the trade names XpressO Silver(TM) and RetrO Silver™). A sophisticated vacuum-based thin film deposition process, the Ion Beam Assisted Deposition (IBAD) deposits the coating that is quite enduring.
OraSure Technologies, a name in oral fluid diagnostics and maker of the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test is trying its darn good to get an FDA’s approval for its HIV testing products to be used at home. The OraQuick ADVANCE is the first & only FDA-approved rapid point-of-care test that is able to produce the precise results for both HIV-1 and HIV-2 in mere 20 minutes. The PA-based company commits to make the test available to masses. Right now, these products are used in clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations. Let’s see if their HIV testing technology for use at home gets the FDA’s approval or not.
Daniel Smith and Darell Reneker, researchers at the University of Akron have developed a new type of Nanofiber based bandages that can speed up the healing process of the human body. The duo used electricity to spin ultrafine polymer fibers and infused them with chemicals so that the wound is always open to oxygen. The result is a bandage that can kill bacteria and also speed up the slow healing process. The bandage is extremely helpful for diabetics as their wounds don’t heal that easily. The reason behind this is that diabetics don’t produce nitric oxide gas that is an important chemical for body repair. The bandages release this chemical which helps the diabetics get rid of their wounds as soon as possible. The bandages are also inexpensive, lightweight and elastic and they stay on the wound without sticking on to it. The first human trials are being done in Columbia and the researchers believe that the results will definitely win them FDA approval. Smith also commented that the bandages will be ready for production by 2008.
Respironics has launched BiPAP autoSV, a FDA approved device intended to provide noninvasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing. What is Sleep Apnea? During a normal sleep cycle, you fall asleep in stages. Your body goes through five sleep stages that begin with drowsiness, advancing to a light sleep, drifting into a deep sleep, and ending in the fifth stage called Rapid Eye Movement (REM). If you have sleep apnea, your body stops breathing for a few seconds during this sleep cycle. Your system signals that there is a lack of oxygen and jolts you awake to kick start your breathing. So, your body has to start the sleep cycle again. This may leave you feeling very tired the next day. You may not even notice or remember that you awoke during the night because it happened so quickly, but in most sleep apnea sufferers, breathing starts and stops several times. Some patients can even experience hundreds of episodes a night. Untreated, sleep apnea can cause high blood pressure and other cardiovascular disease, memory problems, weight gain, impotency, and headaches. Solution: The BiPAP autoSV device delivers optimal therapy for these complicated sleep-disordered breathing patients utilizing a multi-level algorithm. On a breath-by-breath basis, the revolutionary algorithm utilizes Respironics’ core technologies to adjust pressure support upon detecting a sleep event, such as an apnea, hypopnea or periodic breathing, to stabilize the patient’s breathing pattern. This algorithm also calculates the patient’s spontaneous breathing rate and will automatically trigger a breath for the patient should a sleep event occur.