FDAnews Device Daily Bulletin

Two months after the Supreme Court’s ruling in Mayo v. Prometheus, investment dollars are still flowing into biotech initiatives, but legal experts say the real ramifications of that decision could be years away.

The FDA has escalated a long-simmering dispute with Israeli-owned software developer NeuroTrax about the proper classification for its MindStreams cognitive health assessment tool, telling the company in a warning letter it must seek Class III status or halt marketing the product.

House Republicans are vowing to repeal a tax on makers of medical devices by supporting a bill from a GOP lawmaker, and they expect at least a few Democrats to join them in their latest effort to poke holes in President Barack Obama’s healthcare law.

MagForce, a leading medical device company in the field of nanomedicine with focus on oncology, and Tek Grup, a Turkish medical product distribution company, announced the signing of an exclusive distribution agreement.

An epidural catheter from medical device company Teleflex has received 510(k) clearance from the U.S. Food and Drug Administration.

ViewRay has announced it has received FDA 510(k) clearance for its MRI-guided radiation therapy system.

MRI Interventions, a company developing minimally invasive neurosurgery systems, launched an initial public offering with shares at $1.

The overfilling of Hospira’s Carpuject ready-to-use drug syringes previously reported for two injectable painkillers may also be seen in at least 13 other products, the FDA said.