Ketryx raised $14 million in Series A funds. The startups sells a platform — designed around FDA regulations and quality standards — that automates much of the work required from medical device companies’ development and quality teams.
For those unfamiliar with the CPAP recall situation in question, imagine if one-third of all cars on the road were suddenly recalled for potentially life-threatening issues. Now imagine that in the aforementioned hypothetical automobile recall, the media dedicated its energy almost entirely to reporting on the worsening problem without making viewers aware of potential solutions.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The company received a warning letter on Wednesday related to inadequate quality requirements at the headquarters for its diabetes business. It comes after Medtronic expanded a recall of its MiniMed 600 series insulin pumps.
The company initiated the voluntary recall of textured Biocell breast implants and tissue expanders after it received a warning from the FDA that they were linked to some cases of a type of T-cell lymphoma.
More than 650 medical device recalls encompassing 180 million units were registered in the second half of 2016, some of the highest numbers seen this century. It's a poor departure point as a new era in product complexity begins.