As artificial intelligence becomes more central to clinical radiology workflows, Deepc GmbH will use the €12 million (US$13 million) it recently raised in its series A round to develop additional features within its Deepcos radiology artificial intelligence (AI) platform to allow for faster and more accurate diagnoses.

Genialis Inc. reeled in $13 million in a series A financing co-led by Taiwania Capital and Debiopharm Innovation Fund. The funds will be used to build out the company’s store of clinically validated biomarker models for individualized cancer diagnosis.

Aural Analytics Inc. received a breakthrough device designation from the U.S. FDA for its Speech Vitals-ALS technology, a software application that collects and analyzes speech recordings to help monitor amyotrophic lateral sclerosis (ALS) in adults in clinic and home settings. The software could improve management of the devastating disease.

The U.S. FDA gave Bot Image Inc. a coveted threefer with 510(k) clearance for its Prostatid artificial intelligence (AI) software for detection, diagnosis and monitoring of prostate cancer using both standard MRI and a non-invasive bi-parametric MRI, which does not require a contrast agent.

Sofinnova Partners launched a new investment strategy focused on digital medicine in a sign that investment in European startups, especially those at the intersection of biology, data and computation is returning. “It cannot be stressed enough that there is a need in the market for this,” said Edward Kliphuis, partner in the Sofinnova Digital Medicine Strategy.

The Australian government will deliver $50 million to a new biomedical and med-tech incubator (BMTI) program for health discoveries spanning early-stage drug development through to cutting edge medical devices and evidence-based digital health technologies.

Huma Therapeutics Ltd. received the first EU Class IIb approval for a software as a medical device (SaMD) product, winning the certification for its system for collecting and analysing patient data across multiple disease indications, the company reported. The approval will open up the market for digital health apps, with customers now able to link into Huma’s underlying technical platform to develop their own digital health apps and companion diagnostics, avoiding the need to then get their own, separate EU medical device certification.

One way to strike fear into patients and cardiologists alike is to merely mention the abdominal aortic aneurysm (AAA), an event that claims more than 10,000 lives per year in the U.S. alone. That death count might fall substantially going forward thanks to the U.S. FDA’s award of a 510(k) for the AAA algorithm by Viz.ai Inc., a new algorithm which may help clinicians address imminent rupture quickly enough to save the lives of thousands of American patients each year.

Early-stage venture capital firm Karista SAS reported the third edition of its European digital health funds mapping report. This mapping included all funds with global headquarters in France, Germany, Spain, Italy, the U.K., Netherlands, Austria, Luxembourg, Belgium and the Nordics.