FDAnews Device Daily Bulletin

Inamed has received a letter from the FDA regarding its Style 410 cohesive gel-filled breast implants premarket approval (PMA) application.

Arrow International, a company specializing in central venous catheter products, introduced the Arrow Simplicity Micro-Puncture Introducer Set, a new dialysis access product to be used in combination with Arrow's chronic hemodialysis catheters.

IsoTis OrthoBiologics has received 510(k) clearance from the FDA for its DynaGraft II product family for orthopedic applications.

Applied Biosystems Group, together with its joint venture partner MDS Sciex, announced the launch of two new mass spectrometers, the 3200 Q TRAP and the API 3200 LC/MS/MS Systems with Turbo V Source for added sensitivity, throughput and cost-effectiveness in mass spectrometry-based workflows.

Respironics announced that it has acquired all of the outstanding shares of Mini-Mitter, a 34-year-old, privately held company located in Bend, Ore.

Dade Behring, a company specializing in hemostasis diagnostics, announced that their endogenous thrombin potential (ETP) assay for the measurement of thrombin activity is now available for research studies.

Genetronics Biomedical, which is developing oncology and other therapies using electroporation to deliver drugs and nucleic acids, announced that it has changed its corporate name to Inovio Biomedical by filing a certificate of amendment to its certificate of incorporation with the secretary of state of the State of Delaware.

Diagnostic Ultrasound DU, a provider of innovative medical devices, announced the completion of the first phase of a $34 million investment from DW Healthcare Partners and Rho Private Equity.

MedicalCV announced that it has completed the sale of approximately $13.6 million of 5 percent Series A convertible preferred stock and common stock purchase warrants.

IVMD, a developer of noninvasive medical diagnostic tests and products, many of which utilize electromagnetic measurements based on the Hall Effect, a physical phenomena that measures the electrical activity as it relates to magnetic fields, announced that it has received second phase funding from Inverness and Nairn Enterprise, a UK government agency.

SonoSite, a maker of hand-carried ultrasound, announced the results of an independently conducted survey designed to monitor and track satisfaction levels of its U.S. customers regarding the SonoSite TITAN, 180PLUS and 180 ELITE product lines.

The Chang-Gung Memorial Hospital (CGMH) has made a significant additional investment in mass-spectrometry instrumentation from Bruker Daltonics.