The impact of MRI procedures on medical devices has been the subject of regulatory concern for better than a decade, but the FDA needed until 2019 to craft a guidance that deals with testing and labeling for such considerations. The final guidance offers several tweaks and adjustments to the 2019 draft, but ignores several requests made by industry, including a request that the final not rely on a clinically relevant worst-case scenario when evaluating the potential for device heating.

A check up by Khosla Ventures determined that Docbot Inc. was healthy enough for the prominent biotech investor to take the lead in a $4 million series A round. The new funds bring the artificial intelligence company to a total of $8.5 million in capital raised to date. Other participants included Bold Capital Partners, Collaborative Fund and Boutique Venture Partners.

PARIS – Biosynex SA signed a binding offer to acquire 100% of the stock in Avalun SAS, a company developing the Labpad in vitro diagnostic device that provides rapid biological test results from small sample volumes. In Europe, Avalun is currently marketing a follow-up test for patients on anticoagulation therapy using antivitamin K agents, and a test for automated antigen detection for COVID-19.

Veriskin Inc. has emerged from stealth mode with a noninvasive technology for skin cancer diagnosis and screening. The hand-held device, called Truscore, is designed to help nonexpert users quickly ascertain if a suspicious skin lesion is cancerous. Truscore works by detecting and interpreting force-induced hemodynamic differences between normal and malignant skin sores. It uses a proprietary artificial neural network-based artificial intelligence algorithm and protocols to differentiate skin cancers from other harmless skin conditions.

LONDON – Wise Srl has received CE marking for its cortical strip electrode, validating the underlying flexible electronics technology and opening the door to the development of implantable devices for long-term neurostimulation.

In seeming opposition to U.S. Trade Representative Katherine Tai’s support of a proposed compulsory World Trade Organization intellectual property (IP) waiver on COVID-19-related medical products, U.S. Vice President Kamala Harris signed onto the G20’s May 21 Rome Declaration that commits the member countries to work to defeat the pandemic within the current flexibilities of the TRIPS agreement by promoting voluntary IP licensing agreements, technology and knowledge transfers, and patent pooling on mutually agreed terms.