The FDA’s May 4 webinar on patient data generated over the course of the product life cycle covered a number of topics, including the use of social media as a source of real-world evidence (RWE). The FDA’s Anne Hammer said, however, that while social media engagement has exploded over the past couple of decades, issues such as data duplication and verifiability will have to be resolved before patient engagement via social media can be relied upon as a source of RWE for regulatory purposes.

Soulbrain Holdings Co. Ltd. ramped up its unusual diversification program with the acquisition of Pixcell Medical Technologies Ltd. as part of the semiconductor company's shift into health care and in vitro diagnostics. The acquisition of Pixcell follows Soulbrain’s acquisition of Ark Diagnostics Inc. in 2018 as the company looks to the bio-health care industry as its "engine for new growth."

The FDA’s May 4 webinar on patient data generated over the course of the product life cycle covered a number of topics, including the use of social media as a source of real-world evidence (RWE). The FDA’s Anne Hammer said, however, that while social media engagement has exploded over the past couple of decades, issues such as data duplication and verifiability will have to be resolved before patient engagement via social media can be relied upon as a source of RWE for regulatory purposes.

Ceribell Inc. amassed $53 million in a series C fundraising round to broaden the footprint for its noninvasive brain monitor in U.S. hospitals and expand indications for its Rapid Response EEG. Longitude Capital and The Rise Fund led the round.

TORONTO – Opsens Inc. has inked an agreement with Madrid, Spain’s Cathmedical Cardiovascular SA to integrate its coronary physiology algorithms with the Spanish firm’s next generation hemodynamic system, notably Opsens’ diastolic pressure ratio (DPR) for measuring diastolic heart pressure.