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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-41/
- Published: 2022-03-06T12:00:00.000Z
- Updated: 2026-09-14T17:35:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138076

**DEVICES**

FDA has approved an **Intersect ENT** PMA for its Propel Contour steroid releasing sinus implant. The device features an hourglass design for treating patients with chronic sinusitis in the frontal (behind the forehead) and maxillary (behind the cheeks) sinuses. It also has a low-profile flexible delivery system to make it easier to access tight areas of the sinus anatomy.

FDA has cleared **Accelerate Diagnostics**’ PhenoTest BC Kit performed on the Pheno System, the first test to identify organisms that cause bloodstream infections and provide information about antibiotic sensitivity. An agency [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm543150.htm?ref=fdaweb.com) says that the test also reduces the amount of time needed to provide the information, which can guide antibiotic treatment recommendations more easily.

Molecular diagnostic company **Immunexpress** has received 510(k) clearance for the use of SeptiCyte LAB as an aid in differentiating infection-positive (sepsis) from infection-negative (SIRS) systemic inflammation in critically ill patients on their first day of intensive care unit admission. “It is the first RNA-based clinical diagnostic tool, direct from whole blood, to aid medical providers in the early identification of infection in suspected sepsis patients,” the company says. The blood test aids in differentiating infection in 100% of suspected sepsis patients in as few as 4.5 hours from sample draw, it says.

**DRUGS**

FDA has approved an expanded indication for **Celgene**’s Revlimid (lenalidomide) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. The orally administered thalidomide analogue was originally approved in 2006 for use with dexamethasone in patients with multiple myeloma who received at least one prior therapy. In 2015, the indication was expanded for use in combination with dexamethasone for treating patients with multiple myeloma, to include newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplant. Lenalidomide is also approved in myelodysplastic syndromes and mantle cell lymphoma.