PARIS – Incepto Medical SAS, in partnership with Marie-Lannelongue Hospital, is developing an automated system to measure maximum aorta diameter. Called ARVA (Augmented Radiology for Vascular Aneurysm), it’s hosted in the cloud and is CE marked as a class I device. “Our tool uses the first algorithm to provide automatic measurement of external aortic diameter along the entire aorta, from ascending aorta to the iliac arteries,” Antoine Jomier, co-founder and CEO of Incepto, told BioWorld. This new tool for radiologists and surgeons will be used to diagnosis and monitor aneurysms.

Artificial intelligence (AI) is quite the buzzword for med tech and regulators alike, but that doesn’t mean rules for AI are just over the horizon. Pat Baird, director of global software standards at Koninklijke Philips NV, said during a recent webinar that problems such as long-standing definitional issues virtually guarantee that regulatory agencies will struggle to enact regulations, a predicament that leaves software developers with the kind of uncertainty that investors in the life science industries abhor.

Shares of cardiac diagnostics company Heartbeam Inc. (NASDAQ:BEAT) are trading lower than expected after it opened on the Nasdaq on Nov. 11. The digital health company priced its public offering of 2,750,000 units at $6, but as of midday, shares were trading at $4.56. It’s a disappointing start for the Santa Clara, Calif.-based company, which is developing an ECG telemedicine technology to diagnose cardiovascular patients for ambulatory settings.

The FDA’s device center has revisited the 2005 guidance for the content of premarket submissions for device software functions, a document that puts much more emphasis on risk compared to the legacy 2005 guidance.

TORONTO - Medtronic Canada ULC, a subsidiary of Dublin-based Medtronic plc, has launched what it calls the “the first dedicated robotic assisted spine surgery platform in Canada.” The Mazor integrates surgical planning, workflow and execution by combining navigation and robotic technologies.

Ultrasound companies, Caption Health Inc. and Ultromics Ltd. are linking up to jointly offer Caption’s AI software platform with Ultromics’ Echogo deep ultrasound analytics for cardiovascular disease detection.

Entities that lack experience in FDA regulation of medical devices may find the going both expensive and time consuming, but there are resources available to these players in the digital health space. Bakul Patel, director of the Digital Health Center of Excellence at the FDA’s device center, said that while he understands that reading through agency guidance is an unpleasant task, the companies that take the time to do so may find their interactions with the agency less iterative and more productive, thus speeding their path to market.

China's National Health Commission (NHC) has released a draft regulation to set entry requirements for the internet health care industry. The draft poses some strict requirements, such as a ban on online consultations for the initial diagnosis. It also prohibits the practice of linking doctors’ income to the sales of drugs and medical devices.