Regulatory/Legal
Medtronic Device Faces Panel
According to FDA, a study for Medtronic's deep-brain stimulation system for epilepsy treatment failed to meet a study goal. The goal was regarding a reduction in the rate of seizures over a three-month span. The agency did concede, however, that in the third month of treatment,...
SEC Drops Wright Medical Investigation
Wright Medical Group will not face any enforcement actions from the Securities and Exchange Commission related to foreign sales practices. The SEC’s Division of Enforcement dropped its informal investigation of the medical device maker, according to a government filing. Wright...
Baxter Dialysis Machines Recalled
Baxter International has issued a recall of its HomeChoice dialysis machines after the device firm received reports of patients overfilling their abdominal cavities. FDA has classified the recall as Class I. The company says it is still trying to find the source of the problem, but...
Industry Gears Up for 510(k) Changes
FDA's public 510(k) meeting is scheduled for tomorrow. Most observers expect the agency to weigh potential changes to this particular approval process and give some sort of indication as to where it is headed. CDRH leader Jeffrey Shuren says that the center wants input from a...
FDA Continues Probe into Radiation Overdoses
Remember the brouhaha a little while ago about patients receiving excess doses of radation from CT scanners? Earlier this week, FDA announced that it was going to start requiring manufacturers of those machines, as well as other imaging devices, to incorporate safety controls that...
FDA to Sybaritic: Stop Making Unapproved Devices
Until Sybaritic Inc. is in compliance with FDA standards, it will stop manufacturing devices used in laser surgery, dermatology, and spa treatments. According to an FDA release, agency inspections that were conducted at the company during the past several years showed violations of...
Can an Amendment Alleviate the Device Tax Burden?
Senators from Minnesota and Indiana are sponsoring a device tax amendment that would exempt companies with annual revenue below $100 million, reports Star Tribune. In addition, companies reporting between $100 million and $150 million would pay an excise tax on 50% of their revenues...
FDA Reform Could Pose a Danger to 510(k) Process
In a Q...
"Bo-Tax" on Cosmetic Surgery
The healthcare reform bill not only plans on taxing medical device manufacturers, it is also proposing to apply a 5% tax for cosmetic procedures. The tax would be paid by patients and collected by doctors. Surgery that would fall under the tax umbrella include procedures that are "...
HHS Outlines Healthcare Reform Effects
HHS has released state-by-state projections of the effect of passage or failure of the healthcare reform package, based on the surrent Senate version. According to HHS Secretary Kathleen Sebelius, the projections demonstrate that “the health care status quo is not an option for our...