• ArthroCare (Austin, Texas) reported results from a study showing that Coblation-assisted procedures eliminated the risk of airway fires, and Coblation-Assisted Sinus Surgery (CASS) procedures lowered the risk of blood loss in nasal polypectomy/endoscopic sinus surgery (ESS). The study compared the risk of airway fire for an electrosurgical device (Bovie) and a bipolar radiofrequency ablation wand (Coblator) in a mechanical chicken cavity model. The study found that the risk of airway fire appeared to be eliminated with Coblation, while electrosurgical devices present a risk of fire during open cavity surgery in oxygen-enriched environments. All experimental conditions were tested for four minutes, or until a positive result was achieved and were repeated in another model to ensure accuracy.

• Arthrosurface (Franklin, Massachusetts) said that its HemiCAP toe hemiarthroplasty product is now approved for reimbursement by Aetna and other major insurance carriers. Metatarsal head resurfacing with the HemiCAP implant provides a treatment approach for patients with Grade II and early Grade III MTP changes. This intermediate patient population can be served with a motion-preserving surgical alternative for providing pain relief and functional improvement. The metatarsal phalangeal joint or great toe is considered one of the most common osteoarthritic joints and the often painful condition of hallux rigidus is reported to be present in females at a rate of 2:1 over males. The underlying disease process of hallux rigidus is not fully understood but it is believed to be associated with joint impingement diseases and previous traumas such as sports or occupational injuries.

• BioImagene (San Diego) has launched iLearn – a new online educational offering for pathologists, in partnership with i-Path Diagnostics – a UK-based biomedical software company. iLearn provides educational modules for histopathology and cytopathology for residents and experienced pathologists. The company says that iLearn brings internet technology and the convenience of online education into pathology training, supplementing the traditional learning methods of trainee pathologists. Digital images, e-learning tools and streaming video are used to deliver virtual case material in pathology

• Guided Therapeutics (GT; Norcross, Georgia) reported completion of its FDA trial for the LightTouch non-invasive cervical cancer detection device. The GT LightTouch technology systematically scans the cervix to identify cancers and pre-cancers painlessly and non-invasively by analyzing the wavelengths of light reflected from cervical tissue. The LightTouch uses technology to identify cancers and pre-cancers painlessly and non-invasively by analyzing light reflected from the cervix. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the non-invasive test does not require a tissue sample or laboratory analysis, and results are available immediately.

• HeartWare (Framingham, Massachusett) said that it has received full approval from the FDA of an investigational device exemption for the HeartWare Left Ventricular Assist System (LVAS). HeartWare said in May that it had received conditional approval from the FDA for a U.S. clinical trial of the HeartWare LVAS for use as a bridge to cardiac transplant in patients suffering from end-stage heart failure (Medical Device Daily, May 18, 2008). This conditional approval permitted the company to start its U.S. trial, but included several conditions which HeartWare was required to address to the FDA's satisfaction.

• OBS Medical (Carmel, Indiana) reported FDA clearance for its Visensia Alert (VitalAlert) in the U.S. Formerly know as BioSign, Visensia's automated early warning technology fuses up to five vital signs – heart rate, respiration rate, body temperature, oxygen saturation and blood pressure – into a numerical index. The Visensia Index is an indication of a patient's wellness and can enable significant improvement in clinical outcomes and optimization of hospital resource utilization. When the Index reaches and/or surpasses the default threshold, the VitalAlert is triggered.

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