• Infectech (Sharon, Pennsylvania), which is developing technologies for the production of bacteria and disease testing kits, reported that it has received notification from the FDA of registration of the company and its initial product line for biophasic system devices. Because it was categorized as a medical device that did not require the standard lengthy FDA approval process, Infectech said it intends to begin the production and marketing of its biophasic system devices to cultivate and identify certain pathogenic microorganisms for medical purposes. Its Indentikit product line was developed for the rapid identification and antibiotic testing of disease-causing pathogens to work on a class of bacteria that includes Mycobacterium tuberculosis, Mycobacterium avium complex, Paratuberculosis, as well as Pseudomonas and Nocardia species.

• InfuMedics and InSet Technologies (both East Walpole, Massachusetts) reported receipt of the CE mark for the Prometra Programmable Pump. The implantable, programmable pump system is based upon InfuMedics' technology capable of delivering a wide array of therapeutic compounds. InSet Technologies was formed as the sales and marketing company for all InfuMedics Implantable Pump products. Focused efforts are now dedicated to Europe for the company's implantable pump offering.

• Nanobac Life Sciences (Tampa, Florida) said that researchers have described a relationship between nano-bacteria and urological disorders such as kidney stones, prostatitis and polycystic kidney disease. Until these studies, no single infection had been indicated that could have promoted these disease processes. Because of the debilitating nature of these urological diseases, and the company's belief that nanobacteria might play a key role in their development, Nanobac said it has focused on investigating the relationship between nanobacteria and these diseases. Nanobac has identified two biomarkers of nanobacterial infection, and expects to file for FDA approval of its NB2 ELISA assays to detect nanobacterial antigen and IgG antibody. It also is developing the first FDA-approved therapeutic to treat nanobacterial infection.

• Smith & Wesson (Springfield, Massachusetts), a firearms maker and law enforcement products company, reported the introduction of its second-generation automated external defibrillator (AED) at the Shot Show in Las Vegas last month. The Smith & Wesson Heartbeat AED is manufactured by what the company called “a well-known and highly respected, 90-year-old U.S.-based medical products manufacturer of defibrillators and other medical equipment“ and marketed by Pride Development Holdings, its exclusive worldwide AED licensee. Using new technology, the unit and associated accessories simplify defibrillator usage for non-medical personnel and substantially increase the probability of saving the life of a victim who has suffered sudden cardiac arrest. The new Smith & Wesson program will target police officers and emergency responders. At just 3.5 pounds, the Heartbeat unit is small, lightweight and portable, using a long-life lithium battery, and has a rapid, five-second charge cycle.

• Syneron Medical (Yokneam, Israel) and its North American subsidiary, Syneron, which makes ELOS combined-energy medical aesthetic devices, reported that FDA representatives gave the go-ahead for Syneron to submit a 510(k) premarket notification for marketing clearance of its VelaSmooth system in the U.S. The VelaSmooth is sold in Europe and Canada and in other countries around the world for treatment of cellulite. The company said it will be “working expeditiously“ to prepare and file an updated 510(k) application. The company's Electro-Optic Synergy technology provides the foundation for effective, safe and cost-effective systems that enable physicians to provide advanced solutions for a broad range of medical-aesthetic applications.

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