Forrest R. Whittaker, Chief Executive Officer, Avalign Technologies, Inc.
Forrest Whittaker was named Chief Executive Officer of Avalign Technologies, Inc., in January 2007. His company-wide responsibility covers the four... Jun 30 2010,
Micropulse Inc
Committed to quality, integrity, and servant leadership. Columbia City, IN | United States
FDA Seeks 21st Century Agility with 510(k)s
FDA introduced several changes, including new initiatives to clarify the 510(k) submission process. How will these changes affect your device’s pathway to market clearance? Oct 02 2014,
FDA 510(k) Recap: Joint Replacement Updates and Line Extensions
To date in 2020, joint replacement players like Arthrex, Conformis, DePuy Synthes, Medacta, Zimmer Biomet and others have gained FDA 510(k) clearance for a variety of updates and line extensions for their knee, hip and shoulder devices. Apr 21 2020,
FDA 510(k) Recap: Spine Company Clearances
Spine continues to commercialize more products than other orthopedic sectors due to players of all sizes launching a robust list of new products each year. This month, we recap multiple launches from CarboFix Orthopedics, Cutting Edge Spine, Life Spine, Medacta and SeaSpine. Jul 20 2020,
FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions
FDA attempts to clarify substantial equivalence requirements in its latest 510(k) guidance. What do these changes mean for your next submission? Sep 09 2014,
Sunshine Act and Beyond: Improving Compliance
A crucial component of the new regulatory environment is adherence to the Physician Payment Sunshine Act, requiring manufacturers to report payments or transfers of value made to HCPs and teaching hospitals. This article provides an overview of current challenges and key strategies for enhancing compliance. May 07 2014,
FDA Provides Clarity on Premarket Submissions for Medical Device Software
Learn about the information that needs to be documented during the development, verification and validation of software-enabled devices. Sep 11 2023,
The Starting Line: Turning the Corner with a Device Concept
New orthopaedic device concepts from surgeon entrepreneurs and novice inventors often hit snags when facing the reality of the regulated industry. Understanding the barriers in each step of commercialization yields a more successful outcome. Jul 08 2014,
FDA 510(k) Review: 2019 Additively-Manufactured Product Clearances
Spine implants accounted for the majority of the additive manufactured products that received FDA 510(k) clearance in 2019. Our review of clearances include the industry's top players and two companies with their very first orthopedic-related 510(k)s: Additive Implants and Addivation Medical. Dec 02 2019,