Left to our Own Devices

Europeans are left to their own devices.

Slick and efficient or opaque and patchy—these are two of the views about the European medical device regulatory system expressed during a recent US Congress debate. But unlike the case with, say, consumer drug advertising, the devices industry argues that conditions are more favourable in Europe. “European regs are driven by one key goal: innovation,” one industry report suggests. And another ...

Ancestor to Call Our Own

Controversial new fossils could bring scientists closer than ever to the origin of humanity POITIERS, FRANCE—Michel Brunet removes the cracked, brown skull from its padlocked, foam-lined metal carrying case and carefully places it on the desk in front of me. It is about the size of a coconut, with a slight snout and a thick brow visoring its stony sockets. To my inexpert eye, the face is at onc...

Making Our Own Luck

QuickCheck-style property-based random testing [4] requires efficient generators for well-distributed random data satisfying complex logical predicates. Writing such generators by hand can be difficult and error prone. We propose a domain-specific language, Luck, in which generators are expressed by decorating predicates with lightweight annotations controlling both the distribution of generate...

Do we own our bodies?

Left to Their Own Devices: Breakdowns in United States Medical Device Premarket Review

Medical devices encompass nearly every medical product that does not achieve its intended purpose through chemical action, from the simple (tongue blades) to the complex (MRI machines), and from the safe (stethoscopes) to the risky (artificial hearts) [1,2]. Certain drug–device combinations, such as drug-eluting coronary stents, are also regulated as devices. The number and complexity of medica...