Approvals

RevMedx Receives CE Mark for Injectable Hemostatic Device

RevMedx gained CE Mark certification for its XStat, an injectable device that can achieve hemostasis in seconds.

The device is used to stop bleeding in patients, stabilizing injuries and giving them time to reach an emergency facility.

The XStat uses a syringe-like applicator to inject a group of small, expanding sponges into a wound that swell and exert hemostatic pressure to stop bleeding.

Fischer Medical’s Cardiac Simulator Gains Clearance

Fischer Medical’s Bloom2 cardiac electrophysiology stimulator received 510(k) clearance from the FDA.

The device is modeled after the company’s original Bloom device but features an new user interface that does not use dropdown menus.

The Bloom2 is used in electrophysiology procedures to treat and diagnose cardiac rhythm disorders. It is designed to have the feel of the original Bloom stimulator introduced in the 1970s.

Tactile Systems Launches Flexitouch Plus

Tactile Systems Technology’s Flexitouch plus, used for treating lymphedema, is now commercially available in the United States after receiving 510(k) approval from the FDA.

The device features the ability to create and save preset therapy programs and it can treat both legs at once for faster bilateral therapy.

Medtronic’s Laser Ablation System Gains CE Mark

Medtronic launched its Visualase laser ablation system for use in neurosurgery procedures in the European market after earning a CE Mark.

The device, guided by MRI images, delivers laser energy to a small targeted area using an applicator to destroy unwanted soft tissue as light is sent through the applicator.

The system earned FDA clearance in 2007 for necrotizing and coagulating small areas of soft tissue.

Innovus’ Glucose Monitoring Kit Gets FDA Clearance

Innovus Pharmaceuticals received 510(k) clearance from the FDA for its GlucoGorx glucose monitoring kit for use in managing diabetes.

The kit can provide glucose level test results within four seconds, according to the company.

The test kit includes a glucose meter, lancet device and test strips and is eligible to enter reimbursement and government supply programs.

Innovus plans to launch the test kit later this year.

Bacteria-Resistant Urinary Catheter Approved for Use in Europe

A urinary catheter coated with bacteria-resistant material received a CE mark for use in European hospitals and will be trialed in six hospitals in the U.K.

The trial will help determine whether the material can significantly reduce infection rates and lower costs for patients requiring a catheter.

The team that discovered the materials said they are getting significant interest from companies who manufacture other medical devices.

Olerup QTYPE Receives CE Mark

Brisbane, California-based molecular diagnostics company CareDx received a CE mark for its Olerup QTYPE Human Leukocyte Antigen (HLA) typing diagnostic.

The test is used by transplant laboratories for real time HLA typing of donors and recipients of organ transplants.

Cancer Genetics Gets 510(k) Clearance for Tissue of Origin Test

Cancer Genetics received FDA clearance for its tissue of origin test after making modifications to the test reagents and software.

The microarray-based gene expression test evaluates the genomic information of tumors to identify their origin.

The test covers 15 of the most common types of tumors, including thyroid, breast, non-small cell lung, pancreas, kidney, bladder and liver cancer.

FDA Clears Roche’s Chlamydia and Gonorrhea Detection Tests

The FDA granted Roche 510(k) clearance for its cobas CT/NG assay for Chlamydia trachomatis and Neisseria gonorrhea for its 6800/8800 systems.

The tests identify the DNA of the sexually transmitted pathogens, so patients can be either symptomatic or asymptomatic.

The assays can be used on urinary samples, vaginal swabs, or endocervical and cervical swab specimens.