Fortimedix Surgical said today it won FDA 510(k) clearance for its FMX314 single-port system for minimally invasive abdominal laparoscopic surgery. Netherlands-based Fortimedix touted the newly cleared FMX314 as the “world’s 1st single-port surgery solution compatible with standard 15mm laparoscopic trocar,” saying the device will reduce port-site complications and reduce post-operative pain. “We are very pleased […]
Food & Drug Administration (FDA)
Amedica wins expanded FDA indication for Valeo II spinal fusion devices
Amedica (NSDQ:AMDA) said yesterday it won expanded FDA clearance for additional sizes of its Valeo II lateral lumbar interbody fusion device. The Valeo II lateral lumbar fusion device is made out of proprietary medical grade silicon nitride ceramic and includes 2nd-generation instrumentation for improved patient safety, the Salt Lake City, Utah-based company said. The device […]
FDA warns on programmable syringe pumps
The FDA today released a safety communication warning of problems with lack of flow continuity when programmable syringe pumps are set to low flow rates. The federal watchdog released the safety notice for any practitioners who would operate or work with programable syringe pumps and those who administer high risk and life-sustaining medication therapies. Programmable syringe pumps […]
Insightec touts near 50% tremor score improvement in pivotal Exablate Neuro study
Insightec today touted results from a pivotal study of its Exablate Neuro system, which met its primary endpoint with patients treated with the system reporting a 47% improvement in a composite tremor score at 3 months. Data from the study were published today in the New England Journal of Medicine. “MRI imaging and thermometry provide a high level […]
Bio2 Medical wins FDA clearance for embolism-snaring Angel catheter
BiO2 Medical said today it won FDA 510(k) clearance for its Angel Catheter designed for pulmonary embolism protection by trapping clinically significant pulmonary emboli. The Golden, Colo.-based company said the clearance includes a 1st ever prophylactic indication to protect critically ill patients at high risk for pulmonary embolism and are contraindicated for anticoagulation. “We are excited […]
FDA clears Impact, U.S.’s 1st concussion management device
The FDA yesterday granted de novo clearance to Impact Applications for its ImPACT computerized neurocognitive concussion management tool, touting it as the 1st of its kind to win clearance from the agency. The application has been granted clearance as a computerized cognitivie assessment aid for concussion, which is a new device category which uses an […]
FDA request delays timeline for Sanofi’s iGlarLixi drug-device combo for diabetes
By Sarah Faulkner The FDA’s request for more data on the iGlarLixi drug-device combination for treating Type II diabetes pushed the timeline for a decision back 3 months, Sanofi (NYSE:SNY) and Zealand Pharma (CPH:ZEAL) said last week. Sanofi said August 19 that it submitted a new data package for iGlarLixi, an injection pen designed to […]
Fujifilm files last PMA module for Aspire Cristalle breast tomosynthesis software
Fujifilm Holdings (TSE:4901) said yesterday it filed its last Premarket Approval module to the FDA for its Aspire Cristalle breast tomosynthesis optional software upgrade for its Aspire Cristalle digital mammography system. The optional upgrade is known as the Amulet Innovality outside of the U.S., and has been available since May 2013 in the E.U., Asia and […]
Power morcellation rates plunged after FDA warnings
Use of electric power morcellation for hysterectomy procedures has significantly declined after the FDA warned against the use of such devices in 2014, according to a new study. Data from the study was published this month in the Journal of the American Medical Association. The study examined a total of 203,520 women who underwent hysterectomy […]
Stryker’s Sage Products expands med wipes recall over B. cepacia contamination concerns
Stryker‘s (NYSE:SYK) Sage Products subsidiary is expanding its voluntary worldwide recall to include lots of impregnated cloth topical skin products over contamination issues with the bacteria Burkholderia cepacia, according to an FDA notice. The recall includes Sage Products’ Comfort Shield barrier cloths, incontinence clean-up cloths, M-care meatal cleansing cloths, Comfort Bath cleansing washcloths and .2% […]
FDA, medical device industry strike deal over user fees
The FDA and the medical device industry hammered out the principles for the user fees medtech companies pay to have the federal safety watchdog review their products. The 4th iteration of the Medical Device User Fee & Modernization Act would allow the FDA to collect nearly $1 billion in user fees over 5 years, beginning […]