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David Filmore

Executive Editor

Rochester, NY
David Filmore has been covering the health care sector as a writer and editor for 16 years. He specializes in devices and diagnostics, particularly focusing on the regulatory and reimbursement dynamics that impact a company’s ability to succeed in the marketplace. Originally trained as a scientist, Dave enjoys dissecting technical topics to reach a core understanding. As a writer and editor, he relishes communicating that understanding, important context and key takeaways for practical use by the reader. Dave has led operations or served on the staff of “The Gray Sheet” for more than a decade, and now oversees Regulatory and Policy content for the new Medtech Insight. Previously, he was an editor with the American Chemical Society, producing content for professionals in the pharmaceutical industry and analytical instrumentation space. He has also worked in the pharma industry, and has a degree in chemistry. Dave lives with his wife and two kids in Rochester, NY.
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Latest From David Filmore

ASTM Forms Exoskeleton Standards Committee

The standards organization's board of directors approved the formation of a committee that will seek to establish consensus documents for the burgeoning sector.

Standards Policy

Device Designed To Improve Spine-Surgery Outcomes Gets FDA Panel Date

US FDA says its Orthopaedic and Rehabilitation Devices Panel will convene Dec. 12 to weigh issues surrounding ongoing review of Intrinsic Therapeutics' PMA for its Barricaid anular closure device, intended to close a hole created by a spine discectomy procedure to prevent negative outcomes.

Advisory Committees Approvals

US Approvals Analysis: Cook Churns Out 510(k)s In Q3

The privately held Indiana-based device firm has accelerated its 510(k)-clearance output this year, leading all firms with 19 in the third quarter, and pulling neck-and-neck with perennial leader Medtronic for 2017. Overall, FDA remains relatively steady on 510(k) volumes and is maintaining its accelerated pace of novel-device approvals.

Approvals Innovation

Device Week, Oct. 5, 2017 – Steps Forward At FDA

On this week’s podcast, we discuss big announcements from US FDA on digital health policy and an upcoming device-center reorganization, as well as the recent resignation of Tom Price as health secretary.

FDA Regulation

US Regulatory Reads, September 2017: Digging Into 510(k) Exemptions, FDA Inspection Reforms

A deep-dive analysis on recent 510(k) exemptions and an in-depth feature on new device facility-inspection reforms from Congress were popular items in Medtech Insight last month, topped only in the US regulatory arena by our latest Compliance Corner feature article. Also attracting interest: regulatory issues in cybersecurity, digital health, and real-world evidence.
Regulation United States

MDUFA IV Makeover For US FDA Guidances

The US agency detailed new review performance goals and user-fee policies to mark the start of a new fiscal year and five-year user-fee program.

Regulation Legislation
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