Approvals

FDA Grants Pre-Market Approval to Spectranetics’ Drug-Coated Balloon

Spectranetics secured FDA pre-market approval for its Stellarex drug-coated balloon.

The device, aimed at returning blood flow to the femoral and popliteal arteries, went through five randomized trials. The device proved safe and effective and demonstrated low rates of legion revascularization, the Spectranetics said.

The clinical trial data showed the device’s efficacy in addressing femoropopliteal disease in diverse populations.

Agfa Wins 510(k) Clearance for XERO Viewer Expansion

The FDA awarded 510(k) clearance for advanced clinical applications on Agfa HealthCare’s XERO Viewer.

The viewer is a component of the company’s Enterprise Imaging Platform, which organizes imaging data from various sources in one place. The clearance expands the device’s capabilities to include 3D visualization tools and applications for orthopedics and mammography.

The XERO viewer allows users to view patient images from any web-enabled device using popular browsers.

Quantel Medical’s Photocoagulator Wins FDA Nod

The FDA has approved Quantel Medical’s photocoagulator for treatment of macular edema and peripheral retinal pathologies.

The Easyret device incorporates Quantel’s proprietary ELBA fiber laser technology for 577nm wavelength yellow lasers that the company introduced last year in Europe.

The device is also indicated for pathologies such as diabetic retinopathy and central serous chorioretinopathy.

Immunalysis Fentanyl Urine Test Scores 510(k) Approval

Alere division Immunalysis announced the FDA has granted 510(k) clearance to its Sefria fentanyl enzyme immunoassay.

Fentanyl immunosay tests have previously only been available for forensic testing. The Sefria test will make fentanyl screening available for hospitals, doctors’ offices and other healthcare settings.

Fentanyl abuse is a major driver of the opioid addiction epidemic, with death rates from synthetic opioids increasing nearly 75 percent between 2014 and 2015.

Bruker Receives FDA Clearance for Expanded MALDI Biotyper Claim

The FDA has cleared Bruker for a further expanded claim for the company’s microbial identification system.

The expansion covers 144 new species of microbe, bringing the Biotyper’s library to 424 microbial species cleared for the microbiology market. It also includes a series of new disposable biotargets derived from the company’s AnchorChip technology.

The expanded claim covers expanded workflow tools, including an optically-guided target preparation assistance tool.