Developers of artificial intelligence (AI) algorithms have their own nightmares to deal with, but the FDA is charged with employing a regulatory touch that steers clear of rocky shoals on one side and inescapable whirlpools on the other. The FDA’s Bakul Patel said during a Feb. 25 workshop that the FDA would quickly be swamped if the agency took a traditional regulatory approach to managing the super-iterative digital health space, but that the agency will keep a keen eye on the potential impact on patients as AI begins to move into clinical practice.
U.S.-based device makers have been grappling with FDA cybersecurity requirements for some time, but now the European Union (EU) is working on cybersecurity regulations as well. Throw in privacy requirements by the state of California and the EU’s General Data Protection Regulation (GDPR), and device makers are facing an increasingly complicated world of enforcement and litigation.
Redwood City, Calif.-based Q Bio Inc., which is offering a quantitative assessment of personal health, has come out of stealth mode, scooping up $40 million in a series B funding round led by Andreessen Horowitz. The funds are earmarked to improve its proprietary platform and technology to make its preventive health services faster, better and more affordable for all.
HYDERABAD, India – To continue expanding their footprint and capabilities beyond simple generics to biosimilars and new chemical entities, Indian pharmaceutical companies will have to improve their quality controls, compliance capabilities and, just as importantly, adopt more effective digital strategies.
Nantomics LLC, of Culver City, Calif., reported that research based on the company’s deep learning system has been published in a peer-reviewed journal, highlighting the algorithm’s ability to discern which mutation drives a patient’s breast cancer.
TORONTO – Kitchener, Ontario-based Nicoya Life Sciences Inc. has followed up CA$10 million (US$7.6 million) in series A funding raised in January with its launch of “the world’s first digital benchtop surface plasmon resonance (SPR) system” to boost development of drug therapies.
Nantomics LLC, of Culver City, Calif., reported that research based on the company’s deep learning system has been published in a peer-reviewed journal, highlighting the algorithm’s ability to discern which mutation drives a patient’s breast cancer. The company said their approach is a rapid and cost-effective way to establish the breast cancer subtype, thus giving clinician and patient alike a good understanding of which therapies would be ineffective for that cancer and maximizing the chances for a cure.
Ferrum Health Inc., of San Francisco, is looking to prevent medical errors with the help of artificial intelligence (AI). That caught the eye of Sutter Health, a not-for-profit health care network in Northern California. To that end, the two have unveiled the debut of Ferrum's AI-powered platform as the system to deliver more consistent care to patients.
Dublin-based Medtronic plc acquired privately held Digital Surgery, which is focused on surgical artificial intelligence (AI), data analytics, and digital education and training. The companies did not release the terms of the deal. Medtronic plans to integrate Digital Surgery’s AI technology into its robotic platform and across its portfolio.
LONDON – Consumer smartphone apps that use image processing algorithms to assess and monitor potentially cancerous skin lesions have not been properly tested in clinical trials and cannot be relied on to produce accurate results, according to a systematic review of published studies.
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