All posts tagged FDA
The Impact of Business Strategy and the FDA on the Future of Spine Surgery
At the 11th Annual Spine, Orthopedic & Pain-Management Driven ASC Conference on June 14, Frank Phillips, MD, of Rush University Medical Center and Northwest Orthopedics, both in Chicago, and Nameer R. Haider, MD, of Spinal & Skeletal Pain Medicine in Utica, N.Y., …
Carticept Medical get FDA Approval for Navigator Delivery System
Carticept Medical, Inc., a developer of innovative drug delivery systems, announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its enhanced
U.S. Inspector General Issues Fraud Alert on Doctor-Owned Distributors
The U.S. Office of Inspector General (OIG) has issued a warning about the risk of fraud when doctors own medical device distributors. In a report released on Tuesday, the
NuVasive hit with FDA warning letter over spine device
On March 12, the FDA issued a warning letter to NuVasive for selling Affix Spinous Process Plate systems for uses not approved by the device's 510(k) clearance. The
FDA issues proposal to strengthen post-market med device surveillance
September 10, 2012 | By Julie Bird The U.S. Food and Drug Administration recommends strengthening post-market medical device surveillance in a new report released this month.
Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety
The Food and Drug Administration (FDA) is often accused of serving industry at the expense of consumers. But even FDA defenders are shocked by reports this week of
Consumers lose in latest FDA user fee bill; COI restraints disappear
May 15, 2012 by MassDevice
By Merrill Goozner Over the angry protests of consumer groups, Congress is moving rapidly – and in bipartisan fashion – toCBO Says FDA User Fee Act Will Reduce Deficit – LOL
As reported by the Senate Committee on Health, Education, Labor, and Pensions on May 7, 2012 S. 2516 would authorize the collection and spending of fees by the Food
14 Spine Devices Receive FDA 510(k) Clearance in April
1. Tiger Spine System from CoreLink. 2. Securis Spinal Fixation from Custom Spine. 3. Everest Spinal System from K2M. 4. Choice Spine Vertebral Body Placement (VBR) Device System from Choice Spine. 5. Cervical Plate from Eisertech. 6. Capstone
Senate panel adds safety measures to FDA user fee act
April 25, 2012 by Brad Perriello
FDA: Safety, efficacy, public health – and economy?
GOP Sens. Burr and Coburn team up for PATIENTS’ FDA Act
California implant makers get FDA warnings
Two Murrieta, CA-based implant makers have been called on the carpet by the FDA for lacking quality control over their manufacturing or assembling processes. Orthopedic Alliance, which manufactures a total
Spinal fusion device draws FDA warning letter
Spinal device company Lucero Medical has received awarning letter from the U.S. Food and Drug Administration, primarily over documentation and quality control issues. Hinckley, Ohio-based Lucero produces a cylindrical-shaped, titanium
