Device makers are often cited in U.S. FDA warning letters for making claims not seen in the approved labeling, but the authors of a recent review of artificial intelligence (AI) products cleared by the FDA suggest that FDA documents and marketing materials should disclose the presence of AI in these products. The authors of an article in the Journal of the American Medical Association said that only about 80.6% of the products were represented with accurate statements about the presence of AI, although FDA regulation does not require that marketing materials make such disclosures.
Thirona BV has been awarded $2.73 million in funding from the European Innovation Council (EIC) to fast-track the development of its artificial intelligence (AI)-based lung platform to analyze chest CT imaging. In competition with 554 other submissions, Thirona was one of 51 innovative technology companies awarded the EIC accelerator program grant, the total budget for which is €261 million (US$286.28 million) in 2023.
South Korea is making progress towards incorporating digital medical devices into its health care system and facilitating reimbursements, but these efforts may require giving up some entrenched practices. “Digital medical devices” covers a broad range of products, including software and technologies used in therapeutic interventions. They are usually supported by technologies like the Internet of Things (IoT), artificial intelligence (AI), cloud computing, machine learning, sensors and wearables, data analytics and others that can facilitate the shift from traditional health care into the digital world.
Resmed Inc. has acquired Somnoware Inc., a privately held developer of respiratory care diagnostics software, for an undisclosed price. The deal is Resmed’s third software acquisition in the past year, having snapped up German software-as-a-service (SaaS) maker Medifox Dan GmbH for $1 billion in June 2022 and Mementor GmbH last August.
A group of international partners with expertise in therapeutics, technology, health data management and data science have joined forces to develop a range of digital tools that will predict and monitor dementia. The two-year pilot project launched in the U.K. will see the unique group focus their initial efforts on developing data and digital solutions to complement existing treatments as well as solving issues related to the prediction, prevention, management and treatment of dementia related disorders.
Luminopia Inc. reeled in $16 million in an oversubscribed series A financing led by U.S. Venture Partners. The funds will support full commercial launch of the company’s U.S. FDA-cleared digital therapeutic for the treatment of children ages 4-7 with amblyopia. “We are thrilled to announce the successful close of our oversubscribed series A round, which will allow us to advance our mission of pioneering a new class of treatments for the 15 million Americans who suffer from neuro-visual disorders,” said Scott Xiao, Luminopia’s co-founder and CEO.
Vesalius Biocapital Partners Sàrl has called a first close on its fourth fund at €95 million (US$103 million) and now is targeting a total of €150 million, with new investors to be accepted on a "rolling closing" basis until the final close in 2024.
Israeli venture capital fund, Shoni Health Ventures, launched a new fund focused on startups specializing in digital health and medical devices. Recognizing that innovative solutions with the potential to improve global health may go unrealized as health tech startups struggle to attract early-stage investors, the fund is focused on investing in companies at the pre-seed and seed-stage.
Conformis Inc. has inked a definitive agreement to be acquired by Restor3d Inc., in a move that could potentially create a formidable presence in the personalized orthopedics space. Under the agreement, Restor3d will acquire all outstanding shares of Conformis common stock (NYSE:CFMS) at $2.27 per share in cash. The purchase price represents a roughly 96% premium to Conformis’ closing price on June 22, 2023.
The U.K. government created a new £21 million ($US26.55 million) fund to accelerate the roll out of artificial intelligence (AI) diagnostics and treatment tools across the NHS. The AI Diagnostic Fund will enable hospitals to bid for funding to speed up the deployment of the most promising AI imaging and decision support tools to help patients with cancers, strokes and heart conditions.