Abbott (Des Plaines, Illinois) said it has received 510(k) clearance from the FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with acute myeloid leukemia (AML), one of the most common types of leukemia in older adults. Abbott's Vysis EGR1 FISH pobe kit, the third Abbott FISH assay approved or cleared by FDA in the past two months for oncology applications, detects a chromosomal deletion in bone marrow that is usually associated with an unfavorable prognosis for AML patients, Abbott noted. In AML, fast-growing abnormal white blood cells in bone marrow replace healthy cells and impede the body's ability to fight infection. Eventually, the bone marrow ceases to function properly, leaving patients infection-prone and at risk for bleeding. Some patients may require a stem-cell transplant to replace unhealthy bone marrow with leukemia-free stem cells, the company added.

Cyberonics (Houston) said it has submitted applications to both the FDA and its European notified body, DEKRA Certification, for the redesign of its AspireHC generator, which was the subject of a voluntary product withdraw Aug. 15. Dan Moore, president/CEO of Cyberonics, said the company has identified the cause of the problem and implemented and tested the solution. He said the company will work closely with regulatory bodies throughout the review process but that at this time "we don't know when the reviews will be completed."

Invuity (San Francisco) introduced its illuminated breast retractor system at the American College of Surgeons' 97th annual clinical congress in San Francisco. Designed specifically for breast mastectomies, lumpectomies, sentinel node biopsies and reconstruction procedures, the system integrates the company's Eigr illumination technology into an optimized retractor to enable surgeons to improve visualization of anatomic structures during these procedures. The system includes a family of different retractors designed for various surgical approaches, including reconstructive surgeries. Eigr technology utilizes unique optical structures to control light output to a targeted operative space. By directing light from multiple angles and efficiently managing light across a broad output surface, Eigr virtually eliminates shadows, back reflection, glare and thermal effects such as overheating. Invuity's Eigr breast retractor system is also ergonomically designed so that surgeons have greater comfort and maneuverability.

Prometheus Laboratories (San Diego) reported the commercial launch of its Prometheus IBD sgi Diagnostic test, the company's fourth-generation IBD diagnostic test and the first to combine serologic, genetic, and inflammation markers (sgi), in the company's Smart Diagnostic Algorithm for added diagnostic clarity.

No Comments