FDAnews Device Daily Bulletin
Aug. 2, 2012 | Vol. 9 No. 151
Los Angeles weight-loss surgery clinic Lap-Band VIP has received an FDA warning letter for misleading marketing claims.
The FDA conducted 949 bioresearch monitoring inspections in fiscal 2011 — 220 fewer inspections than in the previous year — with the decrease spread among all relevant agency centers as they move to a more risk-based approach.
Ocon Medical has begun human clinical trials of its new contraceptive intrauterine device (IUD) — the IUB (Intra Uterine Ball).
DySIS Medical announced that the National Institute for Health and Clinical Excellence (NICE) has published positive diagnostics guidance recommending its DySIS cervical cancer screening product to be considered in procurement plans.
Philips Healthcare warned Hong Kong regulators on potential problems in its HeartStart MRx heart monitors and defibrillators, which may not hold up in a “transport environment” such as emergency medical services.
A growing population of elderly people as well as stressful and unhealthy lifestyles have increased the incidence of heart disease and heart failure.
ClearCanvas announced the release of two new workstation products designed to assist with image sharing.
Covidien announced the FDA clearance for its Nellcor Bedside SpO 2 Patient Monitoring System.
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