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Set Alert for Quoted

QUOTED. March 16, 2018. Steven Peikin.

Check out what US Securities and Exchange Commission official Steven Peikin had to say about the implications of the agency’s recent charges and settlement with embattled testing company Theranos.

Quoted Enforcement

QUOTED. March 15, 2018. Pamela Spence.

Check out what Ernst & Young’s Pamela Spence had to say about the business threat to health-care firms from the tech world and how companies must respond.

Quoted Digital Health

QUOTED. March 14, 2018. Jeff Shuren.

The head of US FDA's device center, Jeff Shuren, wants three manufacturers of duodenoscopes to fulfill their obligation to conduct post-market surveillance studies. Check out what he said about Olympus, Fujifilm and Pentax Medical here.

Quoted FDA

QUOTED. March 13, 2018. Carla Kriwet.

Philips has developed a contactless pulse oximetry monitoring technology that has shown promise in a small patient study. Check out what Philips Patient Care & Monitoring Solutions CEO Carla Kriwet said about it here.

Quoted Diagnostics

QUOTED. March 12, 2018. Tom McGuinness.

GE Healthcare's Tom McGuinness says precision health is motivating the company's strategy for growth. Check out what he said here.

Quoted Business Strategies

QUOTED. March 9, 2018. David Northfield.

Check out what London-based attorney David Northfield had to say about how device companies should approach disputes with notified bodies in the EU.

Europe Medical Device

QUOTED. March 8, 2018. Peter Mullenix.

Friedman Rubin attorney Peter Mullenix isn't happy with US FDA's plan to ask for more adverse event reports in a summary format, arguing that it could negatively affect public health. Check out what he wrote to the agency here.

Quoted FDA

QUOTED. March 7, 2018. Peter Ellingworth.

Check out what Association of British Healthcare Industries CEO Peter Ellingworth had to say about the risks of disrupting medtech supply chains with the UK’s pending exit from the EU.

Quoted Brexit

QUOTED. March 6, 2018. Mary Jensen.

Check out what US FDA Neurological Devices Panel Chair Mary Jensen had to say about the biggest point of debate at a recent panel meeting that focused on clinical trial requirements for intracranial aneurysm devices.


Advisory Committees Regulation

QUOTED. March 5, 2018. Jon Hoem.

Check out what Corflow Therapeutics CEO Jon Hoem had to say about the unaddressed problem of microvascular obstruction in heart-attack patients.

Market Intelligence Innovation

QUOTED. March 2, 2018. Doris-Ann Williams

Check out what top UK IVD industry advocate Doris-Ann Williams had to say about the challenges facing the industry in 2018.

United Kingdom Brexit

QUOTED. March 1, 2018. Joerg Kruetten.

Check out what Simon-Kucher & Partners consultant Joerg Kruetten had to say about the opportunities and pitfalls of new medtech business models based on his firm's "Medtech Barometer" survey.

Business Strategies Commercial

QUOTED. Feb. 28, 2018. Oliver Bisazza.

Check out what MedTech Europe's Oliver Bisazza had to say about where things stand with the notified body designation process in the EU and why it is so crucial for the successful implementation of the Medical Device and IVD Regulations.

Regulation Policy

QUOTED. Feb. 27, 2018. Irfan Lateef.

Check out what patent attorney Irfan Lateef had to say about the challenges digital-health start-ups are facing in the current patent environment based on recent court rulings that limit what is patentable.

Quoted Digital Health

QUOTED. Feb. 26, 2018. Yossi Gross.

Israeli serial entrepreneur Yossi Gross – founding partner of medtech incubator and investor group Rainbow Medical – routinely sees start-up companies make common mistakes. Check out what he said here.
Quoted Business Strategies
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