Raising the cash sets Strata up to file for approval of a tumor molecular profiling assay while building out its platform.
The FDA issued a Class I recall for Abbott’s HeartMate 3 left ventricular assist device.
Progress has been made in pediatric drug development, but gaps still exist. What you should know about regulatory updates from an industry expert.
Cosmo sought approval of the colon lesion visualization aid on the basis of one statistically significant trial but has encountered resistance.
Tear Film Innovations raised $8.5 million in venture capital and plans to hire staff following the 510k of its iLux therapy for evaporative dry eye.
Grail has gone 3-for-3 in venture capital rounds topping $100 million—with a $300 million addition bringing its total up to $1.5 billion since 2016.
Beta Bionics received FDA approval for home-use studies of a bionic pancreas that uses AI to vary insulin doses in Type 1 diabetes.
Procept BioRobotics reports positive phase 3 study results for its water-based ablation technology to treat benign prostatic hyperplasia (BPH).
European VC fund Sofinnova Partners has hired Medtronic VP Martin Rothman, M.D., as a venture partner.
The plan is to “cross reference people’s genetics, habits and medical records" along with national data to spot cancer early.
Pierre Fabre and Roche are extending their collaborative effort on the development of an antibody drug conjugate candidate.