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Shawn M. Schmitt

Executive Editor

Miami, FL
Executive Editor Shawn M. Schmitt lives and works in Miami. For more than two decades he has written and edited for various high-profile media outlets, including The New Republic and London's Independent Television News (ITN). Since 2005 he has reported on medical device quality control, compliance and post-market issues. A spirited, creative journalist, Shawn reported from the White House Rose Garden for Counseling Today, met with medical device experts in Costa Rica for Medtech Insight, traveled the US to get the scoop on Medicare funding for DecisionHealth, and wrote about the proliferation of nuclear weapons for National Journal's Global Security Newswire. Shawn holds a Master of Arts in Communication: Journalism and Public Affairs from American University in Washington, D.C. (2004), and a Bachelor of Arts in Journalism and Communications from Point Park University in Pittsburgh (1997).

Latest From Shawn M. Schmitt

Medtech Monthly, Ep. 1: Quality Vs. Compliance

Medtech Monthly is here! Check out the first episode of Medtech Insight's new podcast series: It's a knock-down (not really), drag-out (not really), freewheelin' (very much so) conversation about quality versus compliance, with the US FDA's Cisco Vicenty in one corner, and former FDA compliance chief Steve Silverman in the other.

Medtech Monthly Quality

Compliance Corner: Review Risks When Making Product Or Process Changes, FDA Official Warns

The US FDA compliance officer says medtech manufacturers would be wise to evaluate changes to stay out of hot water with the agency.

Compliance Corner Risk Management

FDA, MDIC Eye Technology Clearinghouse For Advanced Manufacturing

The US FDA is teaming up with the Medical Device Innovation Consortium to establish the clearinghouse, which would nudge medtech companies to adopt novel approaches that could take their manufacturing operations to a higher level.

Manufacturing FDA

Q&A: Meet DHCOE Acting Chief Brendan O’Leary, FDA’s New Digital Health Guru

In this revealing interview, the new acting director of the US FDA’s Digital Health Center of Excellence talks about his new role at the DHCOE, the big shoes he’ll have to fill now that former center head Bakul Patel is gone, the need for new regulatory frameworks for digital health – and how he helped repair the Hubble Space Telescope.

Leadership FDA

FDA Mulls Master File Pilot For Makers Of PMA-Approved Devices Sterilized Using Radiation

The US FDA may launch a pilot program that would allow PMA-holders to submit updated master files to the agency if the manufacturers change sterilization methods.

FDA Safety

Baxter: If Your Lips Turn Blue, Stop Using Our Device

Baxter Healthcare says there’s a risk of decreased oxygen levels or lung over-expansion when using its Volara System “in line with a ventilator.” The firm launched a recall of the device on 1 June.

Recalls Safety
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