Renovia Inc. closed a $17 million C-1 equity funding round led by new investor Parian Global Management. Perceptive Life Sciences, Longwood Fund, Ascension Ventures and OSF Ventures added to their existing investments in the company, which develops prescription digital therapeutics for female pelvic floor disorders.

The FDA has finalized a 2018 draft rule that excludes several digital products from the definition of a medical device, a list that includes medical device data systems (MDDS) used in hospitals. The rule responds to requirements spelled out in the 21st Century Cures Act, which was signed into law in late 2016, making this a project of nearly five years’ duration on the FDA’s part.

Just six weeks after receiving FDA 510(k) clearance for its optical coherence tomography (OCT) imaging system (v2.1), Perimeter Medical Imaging AI Inc. received breakthrough device designation from the FDA for its next-gen product, the OCT imaging system with integrated artificial intelligence (AI).

HONG KONG – Beijing Stonewise Technology Co. Ltd., a med-tech firm that uses artificial intelligence (AI) to aid in the discovery of small molecule drugs, closed series B and B+ financing rounds that added $100 million to its pocket. The company intends to use the proceeds to upgrade its AI-enabled drug discovery platform.

Better Therapeutics Inc. has commenced a real-world evidence study with Steward Health Care to assess the long-term impact of its BT-001 digital therapeutic in the treatment of type 2 diabetes. The investigational prescription solution delivers cognitive behavioral therapy to patients with uncontrolled type 2 diabetes.

PERTH, Australia – In the aftermath of the COVID-19 pandemic, Australia is shoring up its national supply of medical products and making it a national priority to drive economic recovery and ensure future resilience. The objective of the government’s modern manufacturing strategy is to build scale and capture income in high-value areas of manufacturing where Australia either has established competitive strength or emerging priorities.

Microsoft Corp. will purchase Nuance Communications Inc. for $19.7 billion in cash in a move that demonstrates a massive commitment to building out the Microsoft Cloud for Healthcare reported in late 2020. The acquisition, which is expected to close by the end of 2021, doubles the Redmond, Wash.-based company’s total addressable market in the health care provider space, bringing it to nearly $500 billion. The size of the transaction is notable even for a company with the active acquisition history of Microsoft.

Cosmo Artificial Intelligence Ltd. received the FDA’s nod for its GI Genius intelligent endoscopy system. The device – the first of its kind, according to the agency – uses artificial intelligence (AI)-based on machine learning to improve the detection of lesions during colonoscopy. It will be rolled out in the U.S. by Medtronic plc, which has exclusive worldwide distribution rights.