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
Abbott has received CE Mark for its Architect clinical chemistry Hemoglobin A1c (HbA1c) test, which may assist physicians in diagnosing and monitoring diabetes as well as identifying patients at risk for developing diabetes. The HbA1c ...
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
Mauna Kea Technologies has received 510(k) clearance from the US Food and Drug Administration (FDA) for its AQ-Flex 19 miniprobe. AQ-Flex 19 miniprobe is used to provide real-time optical biopsies during endoscopic ultrasound-guided fine ...
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 ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Spine Wave's intervertebral body fusion device. Producing expandable PEEK spacers, the StaXx IB system will now for the first time offer an expandable device with ...
Tags: FDA, Spine Wave
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Teleflex's ARROW VPS G4 device. Used in conjunction with the accompanying disposable ARROW VPS Stylet, the device uses micro-Doppler ultrasound technology along ...
Tags: FDA, ARROW VPS G4 Device
Andrew Technologies has obtained 510 (k) clearance from the US Food and Drug Administration (FDA) for its Autologous Fat Transfer device. The liposuction device, which is based on Tissue Liquefaction Technology, reinjects the adipose ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Carticept Medical's new computer-controlled injection system. The new Navigator Delivery System (DS) is designed to increase the efficiency, comfort, safety and ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Teleflex's ISO-Gard Mask with ClearAir technology. The ISO-Gard Mask is designed to reduce waste anesthetic gas (WAG), exhaled by the patients who are recovering in ...
Tags: FDA, Drug, Anesthetic Gas
Olympus has gained 510(k) clearance from the US Food and Drug Administration (FDA) for its Articulating HD 3D laparoscopic surgical video system. The system, ENDOEYE FLEX 3D, when compared with conventional 2D surgical systems reduces ...
Tags: Olympus, FDA Nod, Flex 3D System
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Monteris Medical's NeuroBlate system for the treatment of brain tumors and other lesions. The MRI system embedded in the device provides visualization and allows ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Terumo BCT's automated blood collection system, designed for collecting and storing platelets in Isoplate platelet additive solution (PAS). The solution, which ...
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
The US Food and Drug Administration (FDA) has granted 510(k) clearance to EOS imaging's new sterEOS 3D imaging software. The sterEOS 1.5 software, which is part of the company's full body, low-dose 3 D EOS imaging system, features new ...
Tags: FDA, EOS imaging, 3D imaging software, Drug