• Artificial Medical Intelligence (Eatontown, New Jersey) reported a new add-on module to the inpatient portion of its EMscribe Dx hospital coding system, providing an automated Present on Admission (POA) solution. EMscribe Dx is a second-generation, computer-aided coding solution that scans patient records for appropriate ICD9CM diagnostic and procedure codes and CPT codes using language-processing technology. The POA module automatically determines whether a diagnosis was present at the time of admission and then generates the appropriate POA status. Currently, most hospitals determine POA status through a manual process. Artificial Medical Intelligence is a healthcare informatics software maker.

• ATS Medical (Minneapolis) reported initial clinical results of stand-alone ablation procedures and an overall expansion into the stand-alone market, using the ATS CryoMaze product line. This line of surgical products, indicated for the treatment of cardiac arrhythmias, is designed to replicate the original cut-and-sew Maze procedure (also known as Cox-Maze-III) by freezing lines in the heart to re-direct electrical impulses. The strengths of the stand-alone procedure using ATS CryoMaze are that it can be done through a small incision, which is appealing to the patient, and provides clinical results similar to the original cut-and-sew full Maze procedure — even in the patient populations that are historically the most difficult to ablate, especially for cardiologists. The robust clinical success of this procedure combined with the minimally invasive access site is leading to a rapid adoption of this procedure for surgical stand-alone procedures. ATS Medical makes cardiac surgery products.

• EndoGastric Solutions (Redmond, Washington) reported positive results at the completion of one-year follow-up on GERD patients in the Phase II multi-center study of the first-generation transoral incisionless fundoplication (TIF 1) procedure and first-generation EsophyX device. The EsophyX device enables surgeons and advanced interventional gastroenterologists to offer their patients substantive anatomical repair without incisions (no skin or internal dissection) for front-line surgical management of GERD patients. EndoGastric Solutions says it has designed the first truly incisionless transoral surgical products that mimic the outcomes of the more invasive, “gold standard” anti-reflux surgeries, laparoscopic fundoplications (i.e., Nissen, Toupet or Hill procedures).

• Hologic (Bedford, Massachusetts) reported the publication of a study evaluating the Hologic MammoSite radiation therapy system (RTS), one, two and three years after treatment. The authors note that the RTS is “logistically simpler, technically more reproducible, and patient ‘friendly’” than other interstitial brachytherapy devices. The MammoSite device is a balloon catheter that is inserted into the cavity created by a lumpectomy (the surgical removal of a breast tumor). MammoSite RTS delivers radiation from inside the lumpectomy cavity over a course of five days. The device targets radiation to the area where tumors are most likely to recur, while reducing exposure to healthy tissue. Hologic specializes in imaging systems, diagnostics and interventional devices for women.

• Light BioScience (Virginia Beach, Virginia) said it has become the first company to receive a 510(k) over-the-counter clearance from the FDA for the treatment of periorbital wrinkles. It said this clearance paves the way for future development of a new anti-aging device to deliver the GentleWaves LED Photomodulation technology directly to the consumer marketplace without a prescription. The company said GentleWaves has been “scientifically proven to reduce the appearance of fine lines and wrinkles through the use of a system of pulsating amber-colored LEDs.” These LEDs are coded to stimulate collagen production while slowing down collagen breakdown. GentleWaves has been proven to reduce fine lines and wrinkles without pain, redness, peeling or downtime. Users spend less than one minute sitting in front of a cascading array of amber colored pulsating lights. Light BioScience specializes in LED photomodulation.

• MacuSight (Union City, California) reported positive preliminary data from a Phase I study of its lead product candidate in patients with wet (exudative) age-related macular edema. Similar to its Phase I study in patients with diabetic macular edema, preliminary results from this prospective study of 30 patients demonstrated that MacuSight’s formulation of sirolimus (rapamycin) was safe and well-tolerated in all doses tested with two different routes of administration. In addition, the company said improvements in visual acuity consistent with anatomical retinal changes were observed following a single administration of sirolimus. It said these preliminary findings demonstrated that sirolimus administered via subconjunctival injections was as effective, if not more so, than sirolimus administered via intravitreal injections.

• Masimo (Irvine, California) said that it will debut its technology for noninvasive and continuous total hemoglobin (SpHb) and oxygen content (SpOC) monitoring. Masimo said that this SET technology platform will provide clinicians with access to real-time trending and tracking of a patient’s total hemoglobin status enabling them to quickly identify conditions of anemia, or blood loss. When patients undergo blood transfusions, clinicians will be able to use Masimo Rainbow SET SpHb to titrate blood and maintain hemoglobin levels within acceptable ranges. Because blood and hemoglobin restoration must be carefully titrated to targeted levels to avoid potentially serious morbidities, Masimo Rainbow SET SpHb provides instant feedback that the proper levels are achieved, advancing patient safety and accelerating recovery. Masimo is the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry products.