Approvals

FDA Clears EKF’s Hemoglobin Analyzer

The FDA granted 510(k) clearance to EKF Diagnostics’ Diaspect Tm POC hand-held, reagent-free hemoglobin analyzer.

The device requires minimal training and it is always on, with no maintenance or calibration required.

The device gives users accurate hemoglobin measurements within two seconds of insertion for analysis. It can be used in a variety of settings as well as by a wide range of health care personnel.

Edwards Gains CE Mark for Transcatheter Tricuspid Therapy

Edwards received a CE Mark for its Cardioband tricuspid valve reconstruction system, a transcatheter therapy used to treat tricuspid heart valve disease.

The therapy uses the same implant technique and design as the company’s Cardioband mitral system and is not yet approved for sale in the U.S.

The device can be positioned precisely to a patient’s anatomy and allows real-time adjustment with simultaneous result confirmation.

Cepheid Receives FDA Clearance for Strep A Test

Cepheid, a molecular diagnostics company, received FDA 510(k) clearance for its Xpert Xpress Strep A test to provide molecular detection of Streptococcus pyogenes (Group A Strep).

The test uses an automated real-time polymerase chain reaction to detect Strep A DNA. It can be performed by untrained users to gather results in around 18 minutes.

The low-risk CLIA-waived test does not require culture confirmation for negative results unless symptoms persist or there is an outbreak of acute rheumatic fever.

Novasight Hybrid Imaging System Wins Marketing Clearance

Conavi Medical’s coronary artery imaging system received 510(k) clearance from the FDA for use in imaging coronary anatomy during angioplasty and stenting procedures.

The device enables simultaneous imaging of coronary arteries using both intravascular ultrasound (IVUS) and optical coherence tomography (OCT).

It can acquire both IVUS and OCT images using a single catheter, combining the resolution and contrast of OCT with IVUS’ larger field of view.

FDA Clears Reza Band for Reflux

The FDA granted 510(k) clearance to Somna Therapeutics’ Reza Band, an externally-worn device designed to reduce symptoms of laryngopharyngeal reflux.

The device applies slight pressure to the cricoid cartilage area located below the Adam’s apple which increases internal pressure of the upper esophageal sphincter. It reduces symptoms like chronic throat irritations and cough, hoarse voice, postnasal drip and difficulty swallowing.

The device, which is worn around the neck, reduces LPR symptoms by stopping regurgitation of stomach contents.

Beckman Coulter Achieves CE Mark for Early Sepsis Indicator

Beckman Coulter’s early sepsis indicator device, a hematology-based test, received CE Mark certification.

The new test will be made commercially available on the company’s recently launched DxH 900 hematology analyzer. The indicator uses the analyzer’s technology to characterize cells in their near-native states.

The hematology-based test is meant to alert emergency department clinicians about the possibility or risk of developing sepsis as part of a routine complete blood count.

FusionVu Application Cleared by FDA for Prostate Biopsies

Exact Imaging, an ultrasound system developer, received 510(k) clearance for adding its Fusion Vu application to the ExactVu micro-ultrasound platform.

The application allows urologists to perform cognitive MRI transrectal ultrasound or micro-ultrasound/MR fusion on the ExactVu high resolution platform.

The new application provides 70-micron real-time resolution of the micro-ultrasound system for targeted prostate biopsies.

Abbott’s Xience Sierra Coronary Stent Approved in Japan

Abbott’s Xience Sierra everolimus-eluting coronary stent was granted national reimbursement by the Japanese Ministry of Health Labor and Welfare to treat coronary artery disease.

The new stent features an enhanced design, a new delivery system and unique sizes for use in challenging cases.

Xience Sierra was developed to help doctors more easily treat individuals with difficult blockages that involve multiple or completely blocked arteries or complications like diabetes.

Abbott Gains FDA Clearance for Sensor Enabled Catheter

The FDA cleared Abbott’s Advisor HD grid mapping sensor enabled catheter for creating detailed maps of the heart.

The device is intended to improve cardiac ablation procedures by providing an inside view of the heart, allowing a more accurate identification of its anatomy.

The sensor captures information such as the direction and speed of cardiac signals, allowing for the creation of high-density cardiac tissue maps for better treatment regimens.