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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

A No-Predicate 510(k) Future? Pending US FDA Policy Might Forge A Path

510(k) clearances are the US market on-ramp for most devices, and proving the device is similar enough to an already-marketed product is the entry toll. But a policy in development at FDA's device center offers an optional approach that avoids predicate comparisons. Center director Jeffrey Shuren says in an interview that he expects the new approach will become the "pathway of choice" for many companies, potentially upending what has been a defining characteristic of the device regulatory landscape for decades.

Regulation FDA

Retroactive Device-Tax Suspension Won't Work, Industry Says, Pressing For Urgent Action

AdvaMed told Republican leaders of the House and Senate that they should rethink any plans to wait until next year to pass a retroactive suspension of the device tax, after the tax has already been reinstituted. The tax needs to be addressed by Dec. 31 to avoid a costly, bureaucratic nightmare, the industry group argues.

Policy Legislation

Device Week, Dec. 14, 2017 – MTI 100

On this week's podcast, we discuss our latest MTI 100 rankings, providing a view on top revenue-getters in the medtech space, and we look at issues that are driving up and down movements on the list.

Commercial Business Strategies

'Least Burdensome' Supersized? Draft Guidance Outlines An Expanded View Of The US FDA Concept

The US agency issued a draft guidance that brings the 20-year old concept of "least burdensome" in medical device regulation to all corners of the device center's activities.

Regulation Medical Device

US Approvals Analysis: Molecular Dx Innovations Make Waves In November

Four novel molecular diagnostics, including two next-generation sequencing platforms, gained FDA approval in November, almost half of the nine novel-device approvals last month. The agency was also active with PMA supplement approvals and 510(k) clearances during the period.

Approvals Research and Development Strategies

US FDA's Gottlieb Takes Digital Device Questions From Senators At Cures Hearing

The commissioner explained to senators he is trying to go beyond the 21st Century Cures Act to further encourage development of innovative digital devices.

Digital Health Policy & Regulation
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