Avicenna.AI has enjoyed a head-spinning series of regulatory nods for its artificial intelligence (AI)-based solutions for serious vascular conditions including stroke, pulmonary embolism (PE) and aortic dissection. The Marseille, France-based company gained CE mark for its tool that quantifies the severity of a stroke based on a CT scan of the brain and displays regions that have suffered infarcts in late May, followed by CE mark and FDA 510(k) clearance for its product that permits emergency triage of PE and aortic dissection from CT-scan imaging in early June.

The FDA and industry are deep into the negotiations over the next device user fee, with the usual array of concerns such as premarket program performance and the volume of user fees. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), has once again given voice to a perceived need for a significant boost in user fee volumes in an interview with a major trade association, suggesting that device makers can expect a significant uptick in fees for PMAs and 510(k)s in the years ahead.

Onconano Medicine Inc. raised around $50 million in series B financing to accelerate the momentum of its technology designed to diagnose and treat cancer with high specificity. The biotech company’s nanosensor works by reacting to low pH and illuminates cancer like a lightbulb, distinguishing cancerous tissue from healthy tissue.

Pear Therapeutics Inc. has joined a growing number of med-tech startups that are merging with special purpose acquisition companies (SPACs) as a backdoor pathway to an initial public offering (IPO). On Tuesday, Pear, a company developing digital therapeutics, reported plans to combine with Thimble Point Acquisition Corp., a blank check company affiliated with the Pritzker Vlock Family Office (PVFO), in a deal valued at approximately $1.6 billion. The $400 million in gross proceeds, including roughly $276 million in cash held in Thimble’s trust account and about $125 million, at $10 per share, from an oversubscribed PIPE (private investment in public equity), will be used to further commercialize Pear’s three FDA-authorized products, advance its pipeline and scale its end-to-end platform.

Medtronic plc won expanded FDA 510(k) approval for its Arctic Front family of cardiac cryoablation catheters for alternative treatment of recurrent symptomatic paroxysmal atrial fibrillation (AF) as an alternative to the current standard first-line treatment, antiarrhythmic drug (AAD) therapy. The Arctic Front family of catheters are the first catheter ablation devices in the U.S. approved to help physicians improve AF patient outcomes before drug failure. They have also been proven to shorten the time to diagnosis, according to Dublin-based Medtronic.

Cleerly Inc. snapped up $43 million in a series B fundraising round to develop artificial intelligence (AI)-enhanced imaging to better understand heart disease and more accurately project patient outcomes. Vensana Capital led the round with participation from the American College of Cardiology, Cigna Ventures, Dititx Partners, Lrvhealth (formerly Long River Ventures), New Leaf Venture Partners and returning investors.