Approvals

FDA Grants 510(k) Exemption for Denture Repair Kits

The FDA issued an order exempting over-the-counter denture repair kits from 510(k) clearance requirements in response to a petition submitted by Hyman, Phelps & McNamara for the class II devices.

The agency determined that the product’s risks and characteristics were well established and that premarket notification was not necessary to provide reasonable assurance of the product’s safety and effectiveness, as long as it remains compliant with existing special controls.

The OTC products consist of materials like powder and liquid glues meant to be applied permanently to a denture to fix breaks or cracks. The agency believes that any changes in the device that could impact its safety or effectiveness will be readily detectable by routine analysis and nonclinical testing.

Panther Orthopedics Receives 510(k) Clearance for PUMA System

Panther Orthopedics won FDA approval for its implantable orthopedic fixation device used in the treatment of orthopedic trauma and sports medicine.

The device delivers continuous compression during bone healing and it allows for a 2.8 mm pilot hole that preserves bone tissue. The system was designed to solve the problems experienced with the use of stiff metal screws that restrict normal physiological joint motion and with flexible fixation devices that creep and lose compression.

FDA Approves 23andMe’s Home Breast Cancer Testing

The FDA approved 23andMe’s at-home screenings for three breast cancer mutations.

The genetic testing company will report the test results as part of its Health and Ancestry product.

Women who carry one of the three BRCA1 and BRCA2 gene mutations are at substantially increased risk for developing breast and ovarian cancer.

Oral Fluid Drug Screen Device Gains 510(k) Clearance

Premier Biotech received 510(k) clearance for OralTox, a rapid oral fluid drug screen device.

The device uses oral fluid as a testing matrix and detects up to 12 drugs simultaneously. Unlike for urine testing, the collection can be fully observed without privacy concerns and it is resistant to alteration.

The test can detect amphetamine, cocaine, marijuana, methamphetamine, opiates and phencyclidine (PCP), and the test can be sent to a laboratory for confirmation. It also offers confirmations of presumptive positive results.

Zebra Medical Scores CE Mark for Brain Bleed Detection Algorithm

Zebra Medical Vision received a CE mark for its brain bleed detection algorithm for integration into its deep learning imaging analytics platform. The algorithm can detect intracranial hemorrhage.

The platform also offers automatic detection for low bone mineral density, vertebral fractures, fatty liver, coronary artery calcium, emphysema and more.

Polyganics Gets Breakthrough Designation for Liver and Pancreas Sealant Patch

The FDA granted breakthrough designation to Polyganics’ Liver and Pancreas Sealant Patch designed to prevent leakage after hepato-pancreato-biliary procedures.

The device is made from a proprietary polymer that seals off surgically treated tissues during the healing process.

The Dutch company received a grant of $1.4 million from the European Fund for Regional Development last December for clinical validation of the device.

Roche’s Hematology Testing Solution Gains 510(k) Clearance

Roche’s cobas m 511 integrated hematology analyzer received 510(k) clearance from the FDA.

The device identifies, counts and categorizes white and red blood cells and platelets, and presents digital images of the cell types.

The cobas m 511 combines a cell counter, stainer, slidemaker and digital morphology analyzer.