Ecolab has introduced Antimicrobial Fruit and Vegetable Treatment (AFVT), a new product to help lower the risk of foodborne illness outbreaks related to ineffective produce washing in foodservice operations. Ecolab noted that AFVT is the ...
Tags: Ecolab, Vegetable Treatment
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 ...
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 ...
BioFire Diagnostics has submitted 510(k) pre-market notification application to the US Food and Drug Administration (FDA) seeking approval for its FilmArray blood culture identification (BCID) test. The application included positive ...
Tags: Biofire, FDA Clearance
BioFire Diagnostics has submitted 510(k) Application to the US Food and Drug Administration (FDA) for its FilmArray Blood Culture Identification (BCID) Panel. The BCID panel provides automatic results for the most common infectious causes ...
Tags: Biofire, Filmarray Blood Culture
California-based medical device Harbor MedTech has gained FDA marketing approval for its first product, Architect, an advanced collagen matrix for treatment of partial and full thickness skin wounds. Harbor president and founder Jerry ...
Exact Sciences has submitted the second module of premarket application (PMA) of its noninvasive stool DNA colorectal cancer screening test to the US Food and Drug Administration (FDA). The module included the required studies and ...
Tags: FDA, colorectal cancer, clinical trial
The US Food and Drug Administration (FDA) has cleared a 510(k) pre-marketing notification (PMA) application of Paragonix Technologies' single-use organ preservation device Paragonix Sherpa Pak Cardiac Transport System (CTS). The CTS helps ...
Tags: FDA, PMA, Paragonix Technologies, CTS
VentriPoint Diagnostics has submitted a 510(k) application to the US Food and Drug Administration (FDA) seeking approval for its 2D-ultrasound system, designed for measuring right ventricle heart function in patients with pulmonary arterial ...
Tags: VentriPoint Diagnostics, FDA, pulmonary arterial hypertension
Exelixis has announced the availability of Cometriq (cabozantinib), indicated for medullary thyroid cancer (MTC), in the US. Diplomat Specialty Pharmacy is distributing the product across the US. Cometriq that is developed to inhibit ...
Tags: Exelixis, Cometriq, tyrosine kinases
BSD Medical has sold its MicroThermX microwave ablation systems and antennas to ADA Medikal, a medical specialty distributor, in Turkey. The sale of multiple MicroThermX systems and antennas forms a part of a distribution agreement signed ...
Tags: BSD Medical, MicroThermX microwave ablation systems, ADA Medikal, Turkey
Brainsway has gained US marketing rights for its Deep transcranial magnetic stimulation (TMS) device, designed for use in patients with depression, who have failed to respond to antidepressant medications, following the US Food and Drug ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to Alphatec Holdings' new products, Pegasus and ILLICO FS Facet Fixation systems. Pegasus, an anchored anterior cervical interbody device, offers single-step deployment ...
Tags: MIS Systems, Alphatec, FDA Approval, New Anterior Cervical Interbody
Alere Inc received confirmation that the US Food and Drug Administration (FDA) has cleared the Techlab® Shiga Toxin Quik Chek test for the US market. Shiga Toxin Quik Chek is the only rapid diagnostic available that can detect Shiga ...
Tags: Alere Inc, Techlab, Shiga Toxin Quik Chek, E.coli
The US Food and Drug Administration (FDA) has granted 510(k) clearance to NeuroMetrix's Sensus pain management system, designed as a treatment for painful diabetic neuropathy. The Sensus system is designed for use as a non-invasive ...