WASHINGTON – The U.S. FDA's 2018 final guidance for payer communications widely was seen as long overdue upon delivery. For his part, Paul Savidge, U.S. general counsel at Philadelphia-based Spark Therapeutics Inc., said his company's development of the required information for such communication was "a massive undertaking" that proved useful a second time when it came to promoting its product after FDA approval. Read More
Palo Alto, Calif.-based startup Doc.ai is training its sights on the $9.5 billion global epilepsy market, with the aim of using artificial intelligence to help patients find the best medication to control their seizures. To that end, the company is teaming up with the Stanford University School of Medicine and the Stanford Epilepsy Center on a digital health trial to develop a predictive treatment model that will identify the right treatment at the right time for individuals living with epilepsy. Read More
DUBLIN – Sofinnova Partners closed its ninth early stage venture capital fund, Sofinnova Capital IX, at €333 million (US$369 million) and is bringing the same playbook to bear on current investment opportunities that it has followed in the recent past. Read More
Magnetic resonance imaging (MRI) machines typically require a dedicated shielded room, as well as an additional room with electronics for analytics. That makes MRI, with a typical costly system that requires whole body immersion and elaborate facilities, not particularly feasible for many health care settings. Read More
TORONTO – Developed by Edmonton, Alberta-based Itraumacare Inc., the Itclamp has undergone multiple independent and peer-reviewed studies demonstrating its efficacy controlling blood flow from wounds to the head and neck during military combat in the Middle East. That's been enough for the U.S. Department of Defense's Committee on Tactical Combat Casualty Care to officially recommend its acquisition for use on battlefields. Read More