Despite a slowdown in the fourth quarter (Q4), med-tech deals concluded the year with the highest deal-value total in BioWorld MedTech’s records. In 2023, a total of $10.63 billion was raised from deals, a 33% increase over the $7.99 billion deal total in 2022. Meanwhile, annual M&A value dropped 58%, from $153.09 billion in 2022 to $64.8 billion in 2023.
With the clock ticking down on 2023, the U.S. FDA seems to be scurrying to push final guidances out the door before the new year. This week, the agency has finalized several guidances, ranging from the use of digital health technology in clinical trials to the use of real-world data (RWD) in drug development.
Patent applications from Bellevue, Wash.-based Aiberry Inc. describe further aspects of its artificial intelligence (AI)-powered mental health screening platform that is designed to improve efficiency and save time for healthcare providers.
The U.S. FDA’s approach to bias covers a large swath of territory, including the potential for bias to creep invisibly into artificial intelligence (AI) products. Yarmela Pavlovic, vice president for global regulatory affairs at Medtronic plc, said at this year’s Artificial Intelligence Summit that regulators may be more wary of the potential hazards of bias in AI compared to non-AI software simply because of the difficulty in anticipating how bias might affect the function of these advanced algorithms.
Zig Therapeutics Inc. reported on new patented systems and methods for the remote diagnosis and treatment of a bacterial infection in individuals with chronic respiratory diseases experiencing acute respiratory exacerbations using automated color vision sputum analysis.
Recruitment underway for Toronto-based Vielight Inc. has commenced recruitment for a clinical trial in the U.S. to study how brain stimulation photobiomodulation (PBM) might mitigate long-term cognitive impairment from long Covid. The study intervention comes on the heels of Canadian approval of a device to treat the acute version of Covid, involving light emitting diodes (LEDs) placed inside the nasal cavity and on the chest to deliver near infrared (NIR) light to the body.
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.
Although digital health technologies are being developed at breakneck speed, policies to reimburse these new technologies are lacking and are desperately needed if Australia is to be competitive in the digital health space, said speakers during the Andhealth Digital Health Summit in Adelaide on May 23.
The €15 million (US$16.45 million) loan Smart Reporting GmbH recently received from the European Investment Bank (EIB) will take the company a “long way” as it looks to expand the use of its artificial intelligence (AI)-based medical documentation technology which “helps clinicians improve their workflow and patients to get better care,” co-CEO Peter Vanovertveld, told BioWorld.
Gilde Healthcare Partners BV raised €600 million (US$658 million) in capital commitments for a new investment fund which will be deployed into companies across Europe and the U.S active in digital healthcare, medical technology and therapeutics. The fund, ‘Venture&Growth VI’, will focus on investing in fast growing companies developing solutions for better care at lower cost.