Signalife gets FDA approval to market cardio monitoring card
LOS ANGELES Signalife on Monday received Food and Drug Administration 510(k) clearance to market and sell without a prescription its ambulatory event recorder.
The device, which Signalife will market as the Fidelity 200 HeartLife Tempo Card, is a flexible, credit-card-sized heart monitoring device that can be used as an early-detection system by patients who desire to independently monitor their heart health.
The card will enable the patient to measure cardiovascular activity during exercise or other everyday activities by holding the event recorder to his/her chest, pressing the “record” button, and recording up to a 45-second event.
The recordings may increase the ability to detect silent ischemia or other difficult to detect abnormalities of the heart.
The event recorder will be capable of storing up to six, 45-second recordings. The patient will then either take the recorder to his or her physician for review, or transmit the data to a subscription-based 24-hour monitoring center where it can be immediately evaluated by a qualified ECG technician, cardiac nurse or cardiologist.
The company anticipates that a final production model of the Fidelity 200 HeartLife Tempo Card will be introduced into the market in the first quarter of 2008.
GSK to market Merck’s Mevacor over-the-counter
PITTSBURGH What better way to try and get a statin sold as a nonprescription remedy than to sign on switch maverick GlaxoSmitthKline, the company that successfully switched complex OTC regimens associated with drugs like orlistat and smoking cessation products?
GlaxoSmithKline and Merck on Monday announced that they have entered into an agreement for the over-the-counter marketing rights for Mevacor. Under the agreement, GSK will have exclusive rights to market non-prescription Mevacor in the United States. Terms of the agreement are confidential but include milestone and royalty payments from GSK to Merck.
“This new partnership with Merck will enable GSK to address the important public health issue of high cholesterol and help patients better manage their health,” stated GSK chief executive officer JP Garnier. “OTC Mevacor will be a dynamic new addition to our fast-growing over-the-counter business and is further evidence of GSK’s ability to partner in new OTC switch opportunities.”
Merck had been planning to present to the Food and Drug Administration its justification to switch Mevacor OTC in December. It’s the third bite at the switch apple for Merck, this time without partner Johnson & Johnson. The companies will jointly seek approval of OTC Mevacor 20mg taken once daily to help lower cholesterol. OTC Mevacor 20mg is proposed for use in women age 55 and older and men age 45 and older with moderately elevated cholesterol and one or more heart disease risk factors.
New supplement helps eliminate hangover-causing agent
LAS VEGAS Cheerz USA on Tuesday announced the release of IntelliShot, a Lemon-lime flavored 1.5 ounce nutrition supplement that contains a proprietary blend of immune system boosters and antioxidants that the company claims help naturally reduce and eliminate acetaldehyde, an organic chemical compound created as the body breaks down alcohol in the liver.
Acetaldehyde is popularly known as the chemical that causes hangovers. The company recommends taking one shot of IntelliShot following every third or fourth cocktail.
Cheerz USA chief executive officer Patrick Cochrane reported that the product has no effect on inebriation, does not absorb alcohol or lower BAC, nor will it circumvent the consequences of overindulgence. “Cheerz is for responsible social drinkers who want the ‘buzz’ without the dangerous lingering effects,” he said.
Approved for sale as a nutrition supplement by the FDA, the product sells online at www.CheerzHangover.com. The IntelliShot product is currently shipping to select nightclubs in Las Vegas, Los Angeles, New York and Miami Beach, Fla.