Bone Index Receives FDA Clearance for the Second Generation Bindex
Finland–based, Bone Index has gained FDA marketing clearance for its second generation Bindex device to help in osteoporosis diagnosis.
The device measures the cortical bone thickness of the tibia and the algorithm calculates the density index.
Roche’s Next Generation Roponin T Test Cleared for Marketing
The FDA has granted marketing clearance to Roche’s Troponin T test as an aid in the diagnosis of myocardial infarction.
The device reports the troponin biomarker within nine minutes.
FDA Awards Biolase Marketing Clearance for Epic Pro Diode Laser System
Irvine, California–based, Biolase received the FDA’s clearance to market its dental diode laser system.
This device is the newest addition to the company’s portfolio of soft-tissue diode lasers.
FDA, Health Canada Clear 7D Surgical’s Image Guidance System
Toronto–based, 7D Surgical has won FDA and Health Canada marketing clearance for its Machine-vision Image Guided Surgery (MIGS) system for spine surgery.
The MIGS technology is embedded in an overhead surgical light, which eliminates line of sight barriers in the operating room. The unit is controlled by the surgeon using a foot pedal.
Camber Gains FDA Marketing Clearance for its Joint Fixation System
Wayne, Pennsylvania–based, Camber Spine Technologies has received FDA clearance for its Siconus SI joint fixation system.
The system is designed for use in adult patients as an adjunct to sacroiliac joint fusion in the treatment of the degenerative sacroilitis, or sacroiliac joint disruptions.
FDA Approves BD’s PleurX Catheter System for Pleural Effusions
Franklin Lakes, New Jersey–based BD (Becton, Dickinson and Company) has won FDA marketing clearance for its PleurX catheter system.
The device system was initially approved in 1997 for managing malignant and recurrent fluid buildup.
With the new indication, the system is now cleared for patients suffering from certain non-malignant recurrent pleural effusion factors, including congestive heart failure and fluid buildup around the lungs.
Prescient Surgical Achieves FDA De Novo Clearance for CleanCision System
FDA’s CDRH has granted de novo clearance to Prescient Surgical’s CleanCision wound retraction and protection system.
The device is designed for surgical wound edge protection, retraction, and continuous cleansing with a sterile irrigant solution.
Prescient plans to launch the CleanCision device in 2017.
Fujifilm Gains FDA Approval for Mammography System Software
Stamford, Connecticut–based, Fujifilm Medical Systems U.S.A has achieved FDA approval for its Digital Breast Tomosynthesis (DBT), an optional software upgrade for its Aspire Cristalle digital mammography system.
With the DBT software option acquiring a series of low-dose image slices at different angles, producing a three-dimensional image. The acquired images are reconstructed into a series of 1 millimeter slices, making it easier to identify lesions that might be difficult to see in traditional 2D mammography images due to overlapping breast structures.