By David Pyott
Blog
COFEPRIS strengthens ties to Mexican industry group, plans restructuring
By Stewart Eisenhart, Emergo Group
Mexican medical device market regulator COFEPRIS recently met with CANACINTRA, a major industry trade association, to discuss issues related to the country’s medical device sector. Emergo Mexico staff were in attendance.
Among medical device-related issues that came up at the meeting:
A critical review of the insurance claim denial process
"If you can speak what you will never hear
if you can write what you will never read,
you have done rare things."
-Henry David Thoreau
"Doctor, how much longer?"
Middle East hospital building spree means boost in future demand for medical devices
By Stewart Eisenhart, Emergo Group
Massive healthcare facility construction projects across the Arabian Peninsula suggest a significant boost in near-term regional demand for medical devices and technology, and a major opportunity for foreign manufacturers seeking new markets.
Catching platelets with NETs: Neutrophils and deep vein thrombosis
By Tom Ulrich
Hospitalar 2013: ANVISA plans trial period for 3rd Party B-GMP audits
By Stewart Eisenhart, Emergo Group
During the annual Hospitalar medical device and technology conference in Sao Paolo, Emergo Group learned that Brazilian medical device market regulator ANVISA plans to launch a two-year trial period to allow third-party audits of Brazilian Good Manufacturing Practice (B-GMP) quality systems.
MedWatch: Improving on 20 Years of Excellence
By Margaret A. Hamburg, M.D.
This week FDA is proudly commemorating the 20th anniversary of MedWatch, a program which collects and reviews reports from health professionals and consumers about possible problems with drugs, medical devices and other products regulated by FDA.
CEO Insight: Allergan’s David Pyott Medicare and the medical device tax
By David Pyott
In my last post, I discussed some "macro" Affordable Care Act (ACA) issues impacting the pharmaceutical industry one year after the Supreme Court ruling. Yet for the "big picture" issues, the ACA is the law of the land and there are specific pieces of the law that are concerning.
Spending more to achieve less?
By Jeffrey Binder , CEO, Biomet
U.S. healthcare policymakers are understandably interested in reducing spending on unnecessary and ineffective care. To that end, in some regions of the U.S., Medicare has identified total joint replacement surgery, a highly successful and cost-effective procedure, as presenting potential opportunities for reducing improper payments and utilization.
Scaling up quality improvement: How do we motivate providers?
Reducing health care costs doesn’t have to involve making sacrifices in patient safety or quality of care or holding clinicians to rigid guidelines. Over the past several years, Boston Children’s Hospital has rolled out a methodology known as Standardized Clinical Assessment and Management Plans (SCAMPs).
FDA enforcement letter: Preview of U.S. mHealth regulations?
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration recently issued a letter to Biosense Technologies, developer of the uCheck Urine Analyzer mobile medical application, stating that the firm’s product qualifies as a medical device and must have 510(k) clearance in order to be sold in the US.