The U.S. FDA has granted breakthrough device designation to Laboratory for Advanced Medicine Inc. (LAM) for its liquid biopsy blood test for the detection of liver cancer. The test, which analyzes the DNA methylation pattern of cell-free DNA (cfDNA), is designed to detect the presence of hepatocellular cancer as early as stage 1, with both high specificity and sensitivity.

The FDA's September 2018 draft guidance for considerations of benefit-risk determinations for several device types, including PMAs, said that the agency "intends" to hold an advisory committee hearing if the FDA has any questions about the post-market data generated by the accompanying post-approval study. The final guidance pulls back on that language, but only slightly, stating that the agency "generally expects" to hold an advisory hearing in this circumstance, a difference in language that may or may not translate to a difference in function.

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.

NEW DELHI – Artificial intelligence (AI) is increasingly gaining a foothold in India's health care landscape, with investors pouring money into the new technology, companies developing products and regulators looking to come up with much-needed rules. India's Ministry of Health has reached out to the public for consultation on its national digital health blueprint that seeks to propel digital health care, including the use of AI in the biotech and medical technology sectors.

The FDA's regulation of artificial intelligence (AI) is divided by product center for reasons that are obvious, but precisely what that regulation will look like is anything but. As the FDA's Center for Devices and Radiological Health (CDRH) goes through the comment period for its discussion draft for AI, other nations are starting their own efforts in this space. The American agency's efforts may foreshadow the approaches employed in other nations.

The U.S. FDA has cleared the way for Physiq Inc., of Naperville, Ill., to market its continuous ambulatory respiratory rate algorithm, adding to the company's portfolio of cloud-based analytics for biopharma and health insurance companies. The 510(k) notification will allow Physiq to boost its higher-level artificial intelligence (AI) platform with validated vital signs inputs.

LONDON – France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) has published draft guidelines on the cybersecurity of medical devices, becoming the first national regulator in Europe to specify what manufacturers should do to protect devices against malicious attacks.

PERTH, Australia – The Therapeutic Goods Administration (TGA) has unveiled final guidance that details how the Australian regulator considers cybersecurity risks over the life of a medical device, including whose responsibility it is to assess and communicate risk, as well as the expectations for manufacturers under the Essential Principles. Industry had voiced concerns in reaction to the draft version of the guidance – released last December – that related to proposed changes to the Essential Principles and the use of standards. The TGA had proposed two separate guidances – one for device and in vitro diagnostic manufacturers and those that develop software for medical devices and another guidance for users.