Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Coherus, Cvrx, Sofwave Medical.
Two big pharma firms placed high offers on Dec. 26 to acquire companies focused on radiopharmaceuticals and cell therapies in what Evercore ISI analysts are calling a “good sign for the end of the year.”
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.
More bad news on the recall front for Royal Philips NV, as the U.S. FDA this week categorized the company’s voluntary recall of its Panorama 1.0T HFO open magnetic resonance (MR) system as a class I action. Class I recalls indicate the “use of the devices may cause serious injuries or death,” the FDA noted.
Over the past few years, the health care sector has been progressively leveraging artificial intelligence techniques for activities such as end-to-end drug discovery and development, diagnosing patients, improving communication and engagement between physician and participant, transcribing medical documents and remotely treating and monitoring patients.
Vectorious Medical Technologies Ltd. is seeking patent protection for a method for predicting the occurrence of a heart condition by receiving a multiple measurements of blood pressure acquired in a patient’s heart.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aegis Spine, Claritas, Intelligent Scopes, L&K Biomed, Life Spine, Neuropace.