Breakthrough Indicator Articles & Analysis
7 news found
The second-generation ReFlow Mini Flusher breakthrough device is indicated for use in patients living with hydrocephalus or similar conditions like IIH that may be treated with a shunt. ...
The NIH grant comes on the heels of several key milestones achieved by Selux. Last month, Selux received Breakthrough Device Designation from the FDA for positive blood culture and sterile body fluid sample indications for NGP. The Breakthrough Devices Program provides patients and providers with timely access to medical devices by speeding up ...
QIXLEEF™ is a botanical inhaled drug product with a fixed ratio of THC and CBD that meets USA cGMP regulatory requirements. The drug will be first indicated in patients with cancer suffering of uncontrolled breakthrough pain (REBORN© trials) then in patients with advanced cancer with inadequately controlled pain (PLENITUDE© trials). ...
Food and Drug Administration (FDA) Breakthrough Device Designation for its ReFlow System Mini. The breakthrough indication would allow in-clinic or at-home prophylactic flushing noninvasively by trained patients, caregivers, and clinicians to potentially prevent blockages and extend shunt life. ...
Food and Drug Administration (FDA) Breakthrough Device Designation for its ReFlow™ System Mini intended for the treatment of CSF disorders requiring shunting such as hydrocephalus, a debilitating and life-threatening condition affecting more than 1 million U.S. patients. ...
In an industry first, Industrial Odor Control has built an end-of-life indicator (ESLI) into their filters that will alert users when the carbon inside is saturated and needs to be replaced. ...
This week's U.N. negotiations in Bonn, Germany, are seen as a test of how close or far countries are from a climate deal. Pasztor didn't indicate any breakthroughs. "They're not going to negotiate away all the big issues at this session," he ...