Fear (and paranoia?) over new FDA deputy Bill Maisel (Weekend Rounds)

Here are some of the top stories at MedCity News this week:

- Read the tea leaves and Dr. Jeffrey Shuren, the top Food and Drug Administration official on medical devices, has been saying that the FDA will most definitely tighten its 510(k) program. But in exchange, the agency will provide the device industry much more transparency and certainty. But what to make of Dr. Bill Maisel? Schuren quietly tapped Maisel as the agency’s first deputy director of science for the Center of Devices and Radiological Health. And that appointment will bring no comfort to medical device makers.

- St. Jude Medical is on the way to building a “highly interactive simulation” for the iPhone and iPad to teach doctors and radiologists about optical coherence tomography (OCT). MultiWeb Communications, a firm in suburban Cleveland, will create an app to show how to use the technology from LightLab Imaging, a Massachusetts company recently acquired by St. Jude.

- Good news: Minnesota’s Electromed announced more details on its IPO, continuing the steadier trickle of public offerings. Bad news: It now expects to raise about half of what it said it hoped to back in May.

- A WBB Securities analyst has moved Athersys from a “strong buy” to a “buy” soon after the company reported a $3.1 million loss in its second quarter. The biggest problem: few seem to understand the power of MultiStem, Athersys’ cardiac stem cell therapy.

- And we end with these parting words, courtesy of Buyers Health Care Action Group President and CEO Carolyn Pare: “I challenge the assertion that we necessarily need to move more money toward primary case. Maybe primary care has outlived its usefulness. That sounds awful to say. But I think we need to challenge ourselves to rethink the way care is delivered.”