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The FDA has conditionally approved an investigational device exemption for Archus
Orthopedics' Total Facet Arthroplasty System (TFAS), allowing the company to
initiate a pivotal clinical trial of the device in the U.S.
Bacchus Vascular has announced the recent FDA clearance of the TRELLIS-8 Peripheral
Infusion System, an advanced drug infusion catheter designed for the treatment
of deep vein thrombosis and arterial occlusions by enabling targeted delivery
of clot-dissolving drugs.
North American Scientific announced that it received notice from the Nasdaq
Stock Market stating that it's in danger of being delisted due to its failure
to timely file its latest quarterly financial report.
IVAX announced it has entered into a strategic alliance with Pediatrix Medical
Group to distribute the StepOne Newborn Screening Program developed by Pediatrix's
subsidiary, Pediatrix Screening, throughout Latin America.
A startup that's developing a device to surgically treat arrhythmic heartbeats
has hired a Triangle pharmaceutical industry veteran as its chief executive
and is pursuing $8 million in first round venture funding.
AMS Homecare announced that it has entered into a binding agreement with Wireless
2000 of Burnaby, British Columbia, Canada, to acquire the exclusive distribution
rights to distribute its products into the healthcare, residential elder care,
medical offices and hospital markets in North America.
Using the most advanced 64-slice computed tomography (CT) technology available,
clinical researchers at Beth Israel Deaconess Medical Center announced the completion
of the world's first chest pain evaluation using Electrocardiogram-gated (ECG-gated)
imaging performed with the Toshiba Aquilion 64.