ACC holding imaging conference
Imaging has become a heated topic, embroiling cardiologists and more than 20 other medical specialists in a debate about tests selected and who performs and interprets them.
In San Francisco today through Saturday, the American College of Cardiology (ACC; Bethesda, Maryland) is tackling this topic in its first Integrated Cardiovascular Imaging Conference.
The conference at the Fairmont Hotel features 14 imaging experts examining CT, MR, nuclear and echo. Individual sessions are devoted to each modality, followed by an exploration of imaging for various patient populations and cardiovascular conditions.
DexCom: FDA inspections completed
DexCom (San Diego) reported completing two inspections related to the FDA review of the pre-market approval application for its Short-Term Continuous Glucose Monitoring System (STS).
DexCom filed its PMA for the STS in March and was notified in May that the FDA had accepted the PMA as filed and granted it expedited review status.
DexCom said it successfully completed the FDA pre-approval QSR inspection (previously known as a GMP or good manufacturing practices inspection) of its facility, manufacturing operations and quality systems. It also said it successfully completed the FDA pre-approval bioresearch and monitoring inspection at DexCom and at one clinical trial site for the clinical study filed in support of its PMA.
GE Healthcare grows ultrasound sales
GE Healthcare (Waukesha, Wisconsin) reported that its Global Ultrasound division grew sales by 16% in the first half of 2005 compared to the same period in 2004. That record growth was the result of strong demand for GE’s Vivid i and LOGIQ Book XP compact ultrasound systems, Volume Ultrasound, as well as the Voluson 730, a system for obstetrics and women’s healthcare, the company said.
According to Omar Ishrak, president and CEO of GE Healthcare’s Clinical Systems division, the LOGIQ, Vivid and Voluson ultrasound brands all are performing above projections in their respective markets.
“After a record 2004 performance, we’ve sustained our momentum in traditional ultrasound markets through clinical advancements like Volume Ultrasound, helping clinicians diagnose patients earlier and more precisely, and expanding ultrasound’s role to replace more costly or invasive exams,” Ishrak said. “At the same time, we’re enabling new ultrasound users with . . . laptop-sized systems that bring real-time diagnostic information to the point of care.”