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Q&A: Jeffrey Shapiro Talks Device Approval Strategy And More

 
• By Elizabeth Orr

The seasoned regulatory attorney, who recently moved to law firm King & Spalding, spoke to Medtech Insight about his priorities, what keeps him interested in device law, and the three things manufacturers should consider when seeking a device approval.

Keyboard, notebook, scales of justice and a gavel sit on a black background.
• Source: Shutterstock

Leading device attorney Jeffrey Shapiro has spent more than 25 years representing large, small and in-between manufacturers in their dealings with the US Food and Drug Administration. A graduate of Brown University and Harvard Law School, his areas of focus include regulatory strategy, postmarket compliance, and regulation of combination products. He’s also spoken and written on a wide range of topics from digital health to advertising.

Recently, Shapiro moved from law firm Hyman, Phelps & McNamara – where he had been a director since 2007 – to a new role as partner in the government matters practice at King & Spalding

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

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Califf Warns Progress May Be In Danger Due To ‘Decimated’ FDA Staff

 
• By Barnaby Pickering

In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.

Axoft Starts Commercializing Soft BCI-Enabling Materials For R&D Use, Aims To Rewrite BCI Playbook

 
• By Marion Webb

After publishing encouraging results from first-in-human trials of its brain-computer interface, Axoft announced plans to sell its BCI-enabling material Fleuron to researchers and private organizations for R&D use. The company sees this as a revenue stream and feedback loop to refine its BCI platform designed for safer, longer-lasting brain implants.

Roche To Localize CGM Manufacturing in US with $550M Indiana Site Investment

 
• By Shubham Singh

Roche’s Indianapolis site currently produces 5.2 billion Accu-Chek test strips annually and supports distribution to 53 countries. The new CGM line will add to an already diversified operational footprint, which includes R&D, laboratories, manufacturing, and IT services.