Houston-based startup Braincheck Inc. scooped up $8 million in series A funding in a round led by S3 Ventures and Tensility Venture Partners, along with True Wealth Ventures and Nueterra Capital. Braincheck launched its digital cognitive assessment tool in 2015 and a cognitive care planning solution in 2018, and now the company is looking to broaden its footprint with physician practices, hospitals and health systems. Proceeds from the financing will help to build the company's sales and marketing and clinical development teams in Houston, as well as production development staff in Austin.

The field of artificial intelligence (AI) in medical practice is in its infancy, but a group of medical societies has published a paper that proposes the development of a code of ethics for artificial intelligence (AI) in radiology. The paper underscores a number of concerns, including that some developers fail to fully appreciate the potential consequences of seemingly innocent slip-ups in the development and validation of that algorithm.

BOSTON – The shift to value-based care models and rise in digital technologies is causing medical device companies to rethink how and where they invest in innovation. There's less emphasis on core and adjacent product investments and more focus on transformational advances that don't just add new bells and whistles but expand access, improve outcomes and lower costs. Just what that looks like and how companies are adapting to this new innovation landscape was the focus of a session at the Medtech Conference this week.

HONG KONG – Dreamed Diabetes Ltd., of Petah Tikva, Israel, has received both FDA clearance and the CE mark for an insulin dosing decision support software based on artificial intelligence (AI).

In retrospect, it seems inevitable that an algorithm would be appointed to a board of directors. Hong Kong-based Deep Knowledge Ventures named Vital (an acronym for Validating Investment Tool for Advancing Life Sciences) to its board five years ago and credits it with making better decisions than its fellow members, humans all.

While regulatory science can lag behind technology advances, the FDA has for the past few years been exploring ways to harness the potential of artificial intelligence (AI) to streamline drug development and the approval process. A nexus for its efforts is the Information Exchange and Data Transformation (INFORMED) initiative anchored in the agency's Oncology Center of Excellence (OCE). At its inception in 2016, INFORMED was designed to tap into the power of big data and advanced analytics to improve disease outcomes.

BEIJING – With home-grown artificial intelligence (AI) medical devices under priority review, mainland China is quickly putting together a regulatory framework to more rapidly tap into the power of AI to develop devices and drugs.

PERTH, Australia – It's likely that Australia will not draft separate guidance or regulations for software applications that use artificial intelligence or machine learning (AI/ML) for drug development or medical devices. Instead, the Therapeutic Goods Administration (TGA) will classify AI and ML under software as a medical device (SaMD) when it is intended for diagnosis, prevention, monitoring or treatment or alleviation of disease.