The US Food and Drug Administration (FDA) has cleared the expanded use indication of Boston Scientific's CRE Wireguided Balloon Dilator. The new indication facilitates physicians to perform dilation assisted stone extraction (DASE) of ...
The US Food and Drug Administration (FDA) has granted approval to Actuated Medical's TubeClear system that clears patient feeding and decompression tubes. The CE-marked TubeClear system, which comprises of reusable control boxes and ...
Tags: FDA, TubeClear system, medical technology
Cook Medical has received the US Food and Drug Administration (FDA) approval for its new Evolution colonic controlled-release stent. The new stent design features Kink-resistant flexor technology-based delivery system for pushability ...
Tags: Cook Medical, FDA, medical technology
Delcath Systems has submitted its proprietary chemosaturation delivery system's new drug application (NDA) to the US Food and Drug Administration (FDA). The application includes the use of chemosaturation system along with melphalan ...
Tags: FDA, NDA, medical application
The US Food and Drug Administration (FDA) has cleared Aimago's new tablet-based diagnostic imaging tool to identify poorly perfused tissue. The non-invasive EasyLDI perfusion assessment device uses the laser doppler imaging (LDI) ...
Spacelabs Healthcare, a division of OSI Systems, has received the US Food and Drug Administration's 510(k) approval for its Blease900 ventilator. The Blease900 ventilator, which is an integral component of its BleaseFocus anesthesia ...
Tags: FDA, OSI Systems, Blease900 ventilator
Cook Medical has received the regulatory approval from the US Food and Drug Administration (FDA) for its Zilver PTX drug-eluting peripheral stent, designed for treating peripheral arterial disease (PAD) in the superficial femoral artery. ...
Tags: Cook Medical, FDA, peripheral arterial disease, clinical product
Bausch + Lomb and Technolas Perfect Vision have received 510(k) clearance from the US Food and Drug Administration (FDA)for Victus Femtosecond Laser platform, designed for use during cataract and corneal surgical procedures. The CE-marked ...
Tags: FDA, Victus platform, surgical procedures, platform
US food manufacturer Rich Products Corp has made two acquisitions and formed a joint venture in the US. Pizza to dessert maker Rich's said the acquisition of Goglanian Bakeries and f'real, and its joint venture with The Stolbun is ...
Tags: Rich Products Corp, acquisition, joint venture, portfolio
Cook Medical has introduced a new venous self-expanding stent in Canada, designed to restore blood flow in obstructed iliofemoral veins caused due to post-thrombotic syndrome (PCT). The Zilver Vena stent, which is compatible with 7 Fr ...
Tags: Cook Medical, self-expanding stent, PCT, Zilver Vena stent
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Flexible Stenting Solutions' additional sizes of FlexStent Biliary Self-Expanding Stent system including 9 and 10mm diameters in lengths up to 100mm. The FlexStent ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Covidien's Nellcor bedside SpO2 patient monitoring system. The Nellcor bedside SpO2 monitor, which utilizes OxiMax technology, is designed for detecting heart rate ...
Tags: FDA, clearance, Nellcor, SpO2 patient monitoring system, SpO2 monitor
Spacelabs Healthcare, a subsidiary of OSI Systems, has obtained 510(k) approval for its new compact, sidestream gas analyzer, Capnography Pod, from the US Food and Drug Administration (FDA). Capnography Pod, which is compatible with the ...
Tags: Spacelabs, OSI Systems, approval, FDA
University of California San Francisco (UCSF) Medical Center has purchased BSD Medical's BSD-2000 hyperthermia system. UCSF Medical Center is involved in providing advanced technology and care to patients suffering with cancer. By ...
Tags: UCSF, BSD Medical, BSD-2000 hyperthermia system, cancer
Thermedical has obtained 510(k) clearance for its radiofrequency-based thermal ablation system, designed for treating large volumes of solid tumors, from the US Food and Drug Administration (FDA). Featuring a single or more needles, the ...
Tags: Thermedical, thermal ablation system, FDA, radiofrequency waves, approval