CryoLife has announced the first European clinical implant of its HeRO (Haemodialysis Reliable Outflow) graft following its CE Mark in June 2013. The procedure was performed at the University of Leuven Hospital in Belgium by Professor ...
Tags: CryoLife, Outflow Graft
Hotspur Technologies, a subsidiary of US-based Teleflex, has secured FDA 510(k) clearance to market its ARROW GPSCath Balloon Dilatation Catheters in higher rated burst pressure (RBP) and 80 cm lengths. These products allow several ...
Teleflex, a US-based firm that provides medical devices for critical care and surgery, has won US FDA 510(k) clearance for its Arrow NextStep retrograde femoral length dialysis catheter. The catheter adds to the company's existing ...
Tags: Teleflex, Dialysis Catheters
GE Healthcare has obtained 510(k) clearance from the US Food and Administration (FDA) for its Brivo Plus C-arm, which is made available now in the US. The approval is expected to transform healthcare in private practices and rural ...
Tags: Healthcare, Health&Medicine, FDA
Patient monitoring and respiratory care devices provider Covidien's Nellcor Pulse Oximeters has obtained 510(k) clearance with labeling from US Food and Drug Administration (FDA). Nellcor Pulse Oximeters facilitates in noninvasive ...
Tags: Covidien's Nellcor, Medicine
Covidien has announced that its Nellcor pulse oximetry portfolio received the US Food and Drug Administration (FDA) 510(k) clearance for motion claims. The Nellcor pulse oximetry portfolio, which is used to measure arterial oxygen ...
Tags: Covidien, Motion Claims
Health Canada has approved Life Technologies' applied biosystems 3500 Dx /3500 xL Dx Genetic Analyzers CS2 for diagnostic use. The 3500xL Dx is an automated 24 capillary Sanger Sequencer instrument while the 3500 Dx is an eight capillary ...
Tags: Health Canada, Genetic Analyzers
Masimo (MASI) has received the US FDA 510(k) clearance for its rainbow Acoustic Monitoring sensor, RAS-125c Acoustic Respiration Cloth Sensor for monitoring acoustic respiration rate (RRa) in pediatric patients. The RAS-125c Acoustic ...
Tags: Medicine, Monitoring Sensor
NinePoint Medical has received an additional 510(k) clearance from the US Food and Drug Administration (FDA) for its NvisionVLE Imaging System. The approval will expand the system's indication to include imaging of esophageal tissue ...
US-based surgical and therapeutic solutions provider Vycor Medical has obtained Hong Kong patent for its VBAS minimally invasive brain access system. VBAS, a suite of clear cylindrical disposable devices, is designed to provide ...
Tags: surgical, therapeutic, Vycor
US gastrointestinal endoscopy company EndoChoice has purchased German-based endoscope manufacturer RMS Endoskopie-Technik. Under the acquisition, Full Spectrum Endoscope, a portfolio product of Peer Medical which is now merged with ...
Tags: EndoChoice, RMS Endoskopie-Technik, purchase, endoscope
In keeping with its commitment to excellence and innovation, Masimo announced the debut of the iSpO2 pulse oximeter cable and sensor with Measure-Through Motion and Low Perfusion Masimo SET technology for use with iPhone, iPad or iPod touch ...
Tags: Masimo, iSpO2, iPhone, iPad, iPod touch
SinuSys has received regulatory approvals from Health Canada and Australian Therapeutic Goods Administration (TGA) for its AerOs sinus dilation system, designed for the treatment of chronic sinusitis. Designed for use in office-based ...
Tags: SinuSys, Health Canada, Australian Therapeutic Goods Administration
Teleflex has received FDA 510(k) clearance to market its pressure injectable ARROW PICC preloaded with the ARROW VPS Vascular Positioning System Stylet. The preloaded ARROW PICC enables clinicians to save the time and process of ...
Tags: FDA, Teleflex, medical system
Surefire Medical, a developer of infusion systems, has received CE mark approval for its new Surefire infusion system, designed for use in chemo and radioembolization procedures. The CE mark approval is based on a recent retrospective ...
Tags: CE mark, infusion system, Surefire