GE Healthcare (NYSE:GE) filed the first module of its pre-market approval application for the breast tomosynthesis option of its Senographe Essential system.
The health care giant said the first submission included a device description and non-clinical information, including "phantom testing," and detector performance evaluation. The system is intended as an add-on option for the Senographe Essential to produce 3D images for screening and diagnosis of breast cancer.
GE Healthcare is still collecting and analyzing clinical data for the breast tomosynthesis device and said it plans to file the remaining three modules of the PMA over the coming year.
But an affiliate of health insurer Wellpoint dealt Selenia a blow last month, ruling that use of the device is "investigational and not medically necessary."
Maquet wins 510(k), CE Mark for CardioSave IABP
Maquet Cardiovascular LLC won 510(k) clearance and CE mark approval in the European Union for its CardioSave intra-aortic balloon pump.
J&J’s Ethicon Endo-Surgery gets 510(k) nod for Enseal G2 tissue sealers
Ethicon Endo-Surgery, a division of Johnson & Johnson (NYSE:JNJ), said it won 510(k) clearance from the FDA for its Enseal G2 tissue sealer line.
The clearance includes eight tissue sealing devices of differing lengths and with curved and straight jaw options, the company said. Read more
Cordis lands clearances for Empira dilation catheters
Ethicon Endo-Surgery wasn’t the only J&J division to find favor with the FDA recently. Cordis Corp. won 510(k) clearance for its Empira and Empira NC RX PTCA dilation catheters.
The balloon catheters are the latest iterations of the devices for Cordis, which announced earlier this year that it’s exiting the coronary stents business. Read more
Boston Scientific wins CE Mark for CRE dilator
Boston Scientific (NYSE:BSX) won CE Mark approval in the European Union
for an expanded indication for its CRE wire-guided balloon dilator.
The new indication covers endoscopic dilation of the Sphincter of Oddi after sphincterotomy, allowing physicians to perform dilation-assisted stone extraction in the biliary duct. Read more
Those features include improved touch screen navigation, now offered on all newly produced 2008T machines with Fresenius Clinical Data Exchange. Read more
Biolase lands Korean OK for Waterlase iPlus dental laser
Biolase Technology Inc. (NSDQ:BLTI) landed approval from the Korean Food & Drug Administration for its Waterlase iPlus all-tissue dental laser system. Read more
FDA answers Nephros on hemodiafiltration 510(k)
The FDA responded to Nephros Inc.’s 510(k) application for its hemodiafiltration system for end-stage renal disease, saying it plans to respond to the agency’s request for more information within 30 days or request an extension. Read more
FDA agrees to review U-Systems’ automated breast ultrasound PMA
The FDA will review a pre-market approval application for U-Systems’ somo•v automated breast ultrasound system, for a breast cancer screening application. The device is already cleared for diagnostic use as an adjunct to mammography. Read more
IDEV Technologies wins 510(k) for Supera Veritas stent
The FDA granted IDEV Technologies 510(k) clearance for the its 6 French Supera Veritas transhepatic biliary stent, which is already approved for sale outside the U.S. Read more
TriVascular lands humanitarian device exemption for stent graft
TriVascular Inc. won a humanitarian device exemption for its Ovation abdominal stent graft from the FDA, marking the first HDE granted for abdominal aortic aneurysms. The low-profile device is designed to "expand the pool of treatable patients by addressing a wider range of diseased anatomy," according to the Santa Rosa, Calif.-based company. Read more (PDF)
i-Optics retinal imaging system wins 510(k)
i-Optics won 510(k) clearance from the FDA for its EasyScan smart retinal imaging system. Read more
Diopsys wins CE Mark for vision testing system
Diopsys Inc.’s Visual Evoked Potential vision testing system won CE Mark approval in the European Union; the company said it’s already rolling out the device to EU customers. Read more
IntraPace wins CE Mark for weight loss lead
IntraPace Inc. received CE Mark approval for its LGL102 gastric stimulation/food sensing lead, designed to work with its abiliti implantable weight loss device. Read more
Femasys wins FemChec 510(k)
Femasys Inc. received 510(k) clearance for the FemChec pressure management device, designed for a low pressure HSG as a confirmation test after permanent female sterilization procedures. Read more
CMS to reconsider coverage of blood products for chronic wounds
The Centers for Medicare & Medicaid Services plans to review its coverage decision for blood-derived products for chronic non-healing wounds to determine whether Cytomedix Inc.’s (OTC:CMXI) autologous platelet rich plasma gel is reasonable and necessary under the Medicare program. Read more