Medtronic announced that it’s releasing its new Telescope Guide Extension Catheter, a device that helps to support coronary interventional instruments and extends access to difficult to reach lesions. The Telescope GEC already has regulatory clearances in the United States and European Union. The device features a solid, round pushwire with a (Read more...)
Haemonetics TEG 6s Hemostasis Analyzer Cleared for Trauma Testing
Haemonetics won FDA clearance for its TEG 6s Hemostasis Analyzer System to be used in adult trauma settings to evaluate the viscoelasticity of patients’ blood. The system relies on an all-in-one cartridge into which a small sample of blood is placed. The cartridge already has the necessary reagents within itself, automatically mixing them wit (Read more...)
System Separates, Sequences Circulating Tumor Cells from Whole Blood
Engineers at the University of Michigan have developed a high speed microfluidic chip that can separate circulating tumor cells (CTCs) from whole blood and analyze them. The technology, which may make biopsies and other diagnostic tests unnecessary in many cases, is impressive in that it is able to attract highly rare CTCs and to sequence [… (Read more...)
Prevena Negative Pressure System FDA Approved for Superficial Surgical Site Infections
KCI, now a part of the Acelity Company, has announced that its PREVENA negative pressure incision management system is the first to receive FDA’s indication to help with reducing superficial surgical site infections in those at high risk of post-op infections. The approval comes under the FDA’s de novo pathway that was designed to bring (Read more...)
Prevena Negative Pressure System FDA Approved for Superficial Surgical Site Infections
KCI, now a part of the Acelity Company, has announced that its PREVENA negative pressure incision management system is the first to receive FDA’s indication to help with reducing superficial surgical site infections in those at high risk of post-op infections. The approval comes under the FDA’s de novo pathway that was designed to bring (Read more...)
Xeomin approved as first-line blepharospasm treatment
The FDA has approved a supplemental biologics license application for Xeomin as a first-line treatment for blepharospasm, according to a press release from Merz.Xeomin (incobotulinumtoxinA) was first approved to treat blepharospasm in 2010.A randomized…