The Patient-Centered Outcomes Research Institute is looking to dole out $90 million in support for clinical research, the organization announced today.
Comparative Effectiveness Research
The FDA warned consumers of a classic snake oil scam after hearing dozens of complaints about false advertising of oxygen chambers as a cure for cancer, autism, diabetes and other serious diseases.
With the rapid dissemination of medical information, global reach of the internet, and realization that more print journals doesn’t mean better print journals, today’s researchers use a variety of techniques to connect but most, sadly, have not kept pace with the times.
For those of us who live and breathe healthcare and medtech, the market’s move toward comparative effectiveness is really no surprise. Its drivers abound.
There’s the exceedingly slow global economic recovery and an ever-aging, longer-living patient population. The Patient Portable and Affordable Care Act has the U.S. healthcare market in fundamental transition, with purchase decision-making becoming less about physician preference and more about the C-suite’s bottom line.
MindChild Medical received 510(k) clearance from the U.S. FDA for a new fetal heart monitor the company says can detect tiny fluctuations in fetal heartbeats and potentially reduce the number of Caesarean sections pregnant women undergo.
Company officials said the regulatory win clears the way for the company to commercialize its Meridian non-invasive fetal heart monitor.
MASSDEVICE ON CALL — Sanovas is expanding its corporate headquarters and opening a manufacturing facility in Sausalito, Calif. as it prepares to file for FDA clearance for its drug-delivery technology.
The company’s micro-surgical technologies feature what Sanovas calls the world’s smallest surgical camera to access hard-to-reach areas of the body and provide minimally invasive diagnosis, treatment and drug delivery, according to a press release.
MASSDEVICE ON CALL — The top ten med-tech innovations of 2012, selected by Cleveland Clinic and announced this week spanned the range of health care from detection to treatment to data management.
In the top spot was a system of renal denervation for treatment of high blood pressure. The procedure uses a catheter probe threaded into the renal artery near the kidneys to delivery low-power radio-frequency energy and disrupt nerves, lowering blood pressure.
If you want to grow the expense of health care delivery in America very quickly, then create two government agencies to do the same job.
From the 28 September 2011 issue of the New England Journal of Medicine, we read about a small paragraph in our new health care law that created the Patient-Centered Outcomes Research Institute (PCORI). From that same article, here’s the PCORI’s mission:
The Food and Drug Administration’s Prescription Drug User Fee Act is up for reauthorization next year, and so is the consumer and drug industry face-off over the contentious issue of comparative effectiveness research (CER).