China Awards Expedited Approval to Shuwen
China FDA awarded fast-track status to Shuwen Biotech for its MammaTyper, a real-time PCR kit for breast cancer stratification.
The device is a molecular diagnostic test for breast cancer stratification with Formalin-Fixed, Paraffin-Embedded (FFPE) tumor tissue samples.
Since the fast-track program was initiated in March 2014, only 10 in vitro diagnostics devices have been granted access to the special approval process.
FDA Clears Alere’s RSV Test
The FDA granted 510(k) marketing clearance for Alere’s molecular test that detects respiratory syncytial virus (RSV) in children and adults.
Alere i RSV is significantly faster than conventional polymerase chain reaction (PCR) tests delivering results in 13 minutes or less.
Court Consolidates Theranos Suits
A federal judge in California consolidated six class action suits that accuse Theranos of fraud and false advertising into a single case.
U.S. District Judge Yvonne Gonzalez Rogers for the Northern District of California reasoned that consolidation would “save time and effort.”
The suits poured in after the company rescinded two years of tests results for its Edison blood-testing diagnostics.
Oculus Cleared Post-Dermal Device
Petaluma, Calif.-based Oculus Innovative Sciences has received FDA 510(k) premarket clearance for the company’s post-dermal-procedures device.
The device is intended to remove foreign material and debris after dermal procedures. Oculus plans to market the device in the U.S. in March 2017.
FDA Approves Concussion Tests
FDA has granted approval to Impact Applications’ cognitive assessment devices to evaluate brain function after an injury or suspected concussion.
The Immediate Post-Concussion Assessment and Cognitive Testing as well as ImPACT Pediatric are the first devices the FDA has approved for cognitive testing after a brain injury.
The devices test cognitive skills, such as word recognition, reaction time and memory.
Dexcom Sues InSpark Technologies
Dexcom has filed a suit against InSpark Technologies, claiming it did not infringe on three patents related to glucose-monitoring technology.
InSpark Technologies holds the three patents in dispute that concern the methods for evaluating and monitoring glucose.
Dexcom is requesting a declaratory judgment of non-infringement for ’703 patent, ’985 patent and ’425 patent concerning its Dexcom Clarity software.
Cigna To Cover 3-D Mammography
Cigna announced it will now reimburse for three-dimensional (3D) mammography for routine breast cancer screening effective immediately.
Under its previous policy, the company covered 3D mammography for diagnostic purposes, but not for routine screening.