Guided Therapeutics (OTC:GTHP) made new progress on its once-rejected pre-market approval bid for the LuViva advanced cervical cancer scanning system, which the FDA knocked with a "not approvable" letter in January.
Oncology
Prostate cancer: Intuitive Surgical CEO Guthart on testing and “watchful waiting”
Intuitive Surgical (NSDQ:ISRG) president & CEO Gary Guthart doesn’t believe in taking a passive approach to men’s health.
Intuitive Surgical’s dive continues on prostate surgery study
Wall Street investors are taking another bite out of Intuitive Surgical (NSDQ:ISRG) today, sending its share price down nearly 8% on a study showing that prostate surgery is un-necessary for many men.
ISRG shares dropped fast on Wall Street yesterday afternoon, fueled by the study and soft prostatectomy procedure volumes.
Terumo warns on rare air bubble alert system failure on heart-lung machines
Terumo Corp. (TYO:4543) warned users of its Advanced Perfusion System 1, Sarns Modular Perfusion System 8000 and Sarns Perfusion System 9000 of possible malfunctions related to the devices’ air bubble detections systems.
The company has received "multiple reports" of false alarms generated by the air bubble warning system, although it’s a "highly unlikely" malfunction.
Dune Medical’s MarginProbe breast cancer detection device on track for FDA approval
Following a thumbs-up for its first-of-a-kind MarginProbe breast cancer detection device last week, Dune Medical Devices is promising to work closely with FDA to complete the approval process and plans an immediate U.S. launch should the watchdog agency give it a green light.
The FDA’s general & plastic surgery devices committee met June 21 in Gaithersburg, Md., to mull whether the device, which uses electromagnetic waves to identify possibly cancerous tissue on the edges of a breast tumor, ought to be approved for the U.S. market.
MassDevice.com +3 | The top 3 med-tech stories for June 13, 2012.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
Imagers seek to “debunk” radiation-exposure cancer concerns
A handful of recent warnings about radiation exposure during medical imaging has device makers eager to distance themselves from the potential cancer risk.
Catalyzed by a study finding in recent years a "boom" in the use of medical imaging, the Medical Imaging & Technology Alliance issued a rejoinder arguing that use has begun to decline and that device makers are actively innovating systems that lower the radiation dose.
Rep. Paulsen expects device tax repeal on the House floor this week (video) | MassDevice.com On Call
MASSDEVICE ON CALL — Rep. Erik Paulsen’s long-running effort to repeal the medical device excise tax is nearing a climax in the House, the Congressman said during a recent episode of his regular "Correspondence Corner" videos.
Before answering questions sent by his constituents, Paulsen gave a shout out to Minnesota medical device makers and said he expects his tax repeal bill to get a House vote this week.
MassDevice.com +3 | The top 3 med-tech stories for June 4, 2012.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
Treating brain cancer with electrical fields : “We’re bringing something completely new”
When Novocure won FDA approval for its Tumor Targeting Field cancer therapy system, the company introduced the oncology world to an entire new modality for treatment.
Cancer patients today are most famliar with surgery, radiation and chemotherapy as thearpy optoins, but certain patients can also opt for Novocure’s non-invasive electromagnetic therapy, which promises to stop cancer cells in their tracks without adding a new suite of side effects.
The problem with modeling metastatic cancers: Is it the mouse’s fault?
By Tom Ulrich