> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-19/
- Published: 2021-09-26T12:00:00.000Z
- Updated: 2026-09-14T17:16:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5131715

**DEVICES**

**Alere Inc.** has received FDA 510(k) clearance for its Alere i Strep A test for detecting Group A *Streptococcus* bacteria in throat swab specimens in eight minutes or less. 

FDA has cleared a **Bruker** 510(k) for library and methods expansion for the MALDI Biotyper CA clinical microbiology system. The device was cleared in 2013 and included a library of 40 aerobic Gram-negative bacterial species or species groups, covering 100 clinically relevant species. The new clearance allows an expanded claim to add 170 species and species groups, representing 180 clinically-relevant species of aerobic Gram-positive, fastidious Gram-negatives, *Enterobacteriaceae*, anaerobic bacteria and yeasts. 

FDA has approved a **Flowonix Medical Inc.** PMA supplement for the Prometra II system, which provides automatic dosing of drugs directly into the intrathecal space around the spine. According to the company, the next-generation device features a flow-activated safety valve designed to shut off drug flow to the patient in the event a high flow rate occurs during an MRI, thereby avoiding possible interference from the electromagnetic energy of the MRI. 

**Lensar** has received FDA510(k) clearance for a suite of five new application technologies integrated into the company’s Lensar Laser System, a femtosecond laser cataract platform. “The five distinct upgrades to the platform include innovative integration of functions unique to the Lensar Laser System that, for the first time, allow surgeons to fully automate and customize critical planning and execution steps of refractive cataract surgery,” the company says. The new applications also establish a wireless integration protocol with preoperative diagnostic devices. “This new integration eliminates potential errors that can occur from manual entry of data from the device used in the preoperative and surgical planning process,” it adds. 

FDA has expanded the approved use of **Medtronic**’s CoreValve System to treat certain patients who have previously had a tissue aortic valve replacement and are in need of a second one. “This first-of-its-kind use is called aortic ‘valve-in-valve’ replacement, and today’s approval expands the authorized use of the device to patients in need of this replacement who also are at high or extreme risk for complications associated with traditional open-heart surgery,” an agency release says. The CoreValve is made of tissue from a pig, and is attached to a flexible, self-expanding metal frame made of nickel-titanium alloy. 

FDA has granted 510(k) clearance to **NEC Display Solutions of America** for its MultiSync MD322C8 LCD, an 8-megapixel, 32-inch high resolution display for radiology review applications in healthcare organizations. The company says the monitor has four times the resolution of full HD and features an Open Pluggable Specification-compliant option slot, which is compatible with NEC-provided 3G/HD/SDI input cards for connection to live video streams. 

**HUMAN DRUGS** 

FDA has approved a **Teva Pharmaceutical Industries** NDA for ProAir RespiClick (albuterol sulfate) inhalation powder, a breath-actuated, multi-dose, dry-powder, short-acting beta-agonist inhaler for treating and preventing bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for preventing exercise-induced bronchospasm in patients 12 years of age and older. 

**Novartis** has received FDA approval of Jadenu (deferasirox) tablets, a new oral formulation of Exjade (deferasirox) tablets for oral suspension, for treating chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes in patients 10 years of age and older.