• American Bio Medica (ABMC; Kinderhook, New York) said that the FDA has granted clearance on its rapid TOX cup, a patent-pending drug screen in an all-inclusive cup platform. The clearance allows ABMC to provide the rapid TOX cup to customers in clinical markets. ABMC CEO Stan Cipkowski said: "The rapid TOX cup has already been well received in the criminal justice market as it provides accurate results in an easy-to-use format, all at a lower cost to the customer. This clearance opens up additional markets to ABMC and also allows us to market the product to those customers that want a FDA-cleared productThe rapid TOX cup is an accurate drug screen. The rapid TOX cup doesn't require any manipulation of the device; the donor voids into the cup. Its wide mouth and larger cup allow for easier specimen collection. A temperature strip is affixed to the cup to ensure specimen integrity, with the option to add a specimen validity test strip.
• Aethlon Medical (San Diego) said that the Aethlon Hemopurifier has proven effective in capturing the reconstructed Spanish Flu of 1918 virus (1918rv). During in vitro testing, high concentrations of 1918rv were rapidly depleted from cell culture fluid when circulated through the Hemopurifier. The Hemopurifier also has demonstrated effectiveness in capturing H5N1 avian influenza (bird flu). The Hemopurifier is a broad-spectrum therapeutic device able to separate and then capture circulating viruses by glycoproteins that reside on their surface. In the case of pandemic influenza, the Hemopurifier is able to separate and then capture circulating influenza virus by hemagglutinin (HA) and neuraminidase (NA) glycoproteins that reside on the virus surface regardless of mutation. Aethlon Medical specializes in products to treat infectious disease.
• Cook Medical (Bloomington, Indiana) reported the first human use of its Zenith low-profile AAA endograft system. The Zenith Low Profile AAA Endograft System addresses those areas of concern by reducing the size of the delivery sheath to 16 Fr. This development, if proven safe and effective in an upcoming clinical trial, could open endovascular treatment of aneurysms to a new class of patients who currently have only open surgery as a treatment option due to the small diameter of their blood vessels and other anatomic issues. In addition, it may enable physicians to eliminate the need for a surgical cut down to access the femoral artery and allow the use of the percutaneous entry technique where a needle is inserted to allow the guidewire and delivery sheath to enter the artery with far less trauma. Cook Medical makes products to treat diseases of the aorta.