In a recent issue of Medical Device Daily, Integrity Life Sciences (ILS; Tampa) reported that FDA will investigate the use of robotic surgery, a move said to be sparked by a tripling of adverse events reports between 2008 and 2012.
Tag Archives: FDA
Heresy or common sense? Patients, statistics and medical devices
March 24, 2013 – 12:01 PM
There’s no shortage of important developments in the world of medical devices, but today, let’s discuss this matter of dogmatic adherence to biostatistics. We’ve all heard about the FDA advisory committee that recently recommended the agency approve a neurostimulation device…
Statistical tinkering in device regulation a disservice to patients
March 8, 2013 – 4:37 PM
Despite the regulatory approval of new antiepileptic drugs (AED) over the past decade and the expansion of indications deemed suitable for epilepsy surgery, individuals with intractable seizures – roughly one in three epilepsy patients – still face a dearth of…
Meet the New CED
December 12, 2012 – 11:14 AM
The Centers for Medicare & Medicaid Services has published a draft guidance for the new framework for coverage with evidence development, or CED, a very interesting framework indeed. Following is a list of some fascinating tidbits from the draft guidance.
Election 2012: What it means for device makers
November 9, 2012 – 9:48 AM
There’s a saying that elections have consequences, an observation that has special meaning for the highly regulated medical device industry. Here are a few things for device makers to bear in mind as 2012 gives way to 2013.
Bull in a China shop: Jeff Shuren at CDRH
September 27, 2012 – 7:53 PM
The Center for Devices and Radiological Health may historically be the most interesting of all FDA’s branches, but the goings-on at CDRH since 2009, the year Jeff Shuren took the helm, have been nothing short of eye-popping. When one looks…
