• EarlySense (Ramat Gan, Israel) said its EverOn contact-free patient supervision system has been granted FDA clearance and CE-mark certification. EverOn is a wireless patient supervision system installed underneath a bed mattress. There are no leads or cuffs to connect to the patient. The system measures patient vital signs and movements and alerts nurses or caregivers of any change in condition. EverOn detects heart and respiration rates, bed entries and exits, as well as patient movement. EverOn also helps medical staff to better implement patient turns, which can positively influence the treatment and the prevention of pressure ulcers. EverOn's trend line display is designed to assist clinicians in monitoring the progression of a patient's health and support improved medical decision making.

• KMC Systems (Merrimack, New Hampshire) has launched KMC 360, the company's complete program for contract design, manufacture and maintenance. The program is designed to support OEMs and start-ups throughout the entire medical device and instrumentation product lifecycle by centralizing all outsourcing support. KMC says that by allowing companies to work with one experienced partner, KMC 360 smoothes product transitions from design to manufacture, avoiding costly redesigns and delays. It also enhances field maintenance support by allowing end users to leverage KMC Systems' intimate design knowledge of their systems gained through the design and manufacturing stages.

• St. Jude Medical (St. Paul, Minnesota) reported the completion of patient implants in its U.S. pivotal clinical study of deep brain stimulation (DBS) for the symptomatic treatment of Parkinson's disease, a neurological disorder affecting about 6.3 million people worldwide. The announcement was made at the Movement Disorder Society's 13th International Congress of Parkinson's Disease and Movement Disorders in Paris. "We are excited by the progress we've made in bringing the Libra deep brain stimulation systems to the market," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. "The completion of patient implants in this study and our recent European CE Mark approval represent significant steps towards our goal of providing physicians with an innovative deep brain stimulation system for treating Parkinson's disease." The Libra and LibraXP neurostimulators are constant current devices. The systems consist of a neurostimulator – a surgically implanted battery-operated device that generates mild electrical pulses – and leads, which carry the pulses to a targeted area in the brain.

• Transoma Medical (St. Paul, Minnesota) reported FDA clearance for its new Data Review feature on Sleuth AT. The Data Review feature allows any clinician to easily access up to 99 events stored on the patient's Personal Diagnostic Manager (PDM). The PDM is a hand-held device that retrieves and stores ECG data from the implanted device prior to automatic transmission to the 24/7 monitoring center. Each stored ECG strip is labeled with the time and date of the cardiac event making it easier for clinicians to correlate symptoms with rhythms. The system includes a small implanted device that incorporates a sensitive arrhythmia. The Sleuth AT captures ECG strips containing arrhythmias automatically, and also allows the patient to capture data by pressing a button on the handheld PDM after experiencing a symptom. All data captured by the implanted device is automatically transferred to the PDM, providing an additional 10.5 hours of ECG storage. Data stored on the PDM is automatically transmitted to a 24/7 monitoring center where certified cardiac technicians review the data and alert clinicians to clinically-significant events.