The U.S. FDA posted notice of a recall of the system monitor for the Heartmate left ventricular assist device by Abbott Laboratories, an action necessitated by reports of a series of malfunctions that may lead to inadvertent operator error.
In a ruling delivered June 28, the U.S. Supreme Court brought an end to four decades of a practice of judicial deference to federal government agencies in litigation under the Chevron doctrine, a practice that some argue has enabled regulatory mischief.
Clarius Mobile Health Corp. received U.S. FDA clearance for the Clarius OB artificial intelligence biometric measurement tool, which is designed to improve access to accurate prenatal monitoring in low-resource regions. The system automatically estimates fetal age, weight and growth intervals critical to assessing fetal health and early identification of potential issues and multiple pregnancies.
Nexsen Biotech Pty Ltd. developed a rapid diagnostic test for Group B Streptococcus, a highly prevalent and potentially fatal bacteria that is the single largest maternal health problem faced by pregnant mothers.
Agilemd Inc. received U.S. FDA clearance for its Ecart clinical deterioration suite, an artificial intelligence-powered software as a medical device that uses a machine learning algorithm to continuously evaluate the risk of a hospitalized patient’s death or transfer to intensive care based on 97 real-time variables.
The U.S. FDA reissued a 2022 draft guidance for clinical trial diversity at the behest of legislation from Congress, ballooning the previous nine-page draft to 23 pages.
After spending years battling with Apple Inc. over the consumer heart monitoring market Alivecor Inc. is hoping to bring its technology to the professional health care market with its new device, which recently received clearance from the U.S. FDA.
Endogenex Inc. closed an oversubscribed $88 million series C financing round to support completion of its investigational device exemption trial for the Recet system. The Recet system uses non-thermal pulsed electric fields to remodel the duodenal tissue to treat adults with type 2 diabetes.
Even though the U.S. FTC recently claimed a court victory in its campaign to shut down the listing of device patents for drugs in the FDA’s Orange Book, 80% of the listings targeted in the commission’s first round of warning letters remain in place more than seven months later.
It appears that the expression no news is good news is especially applicable to intra-aortic balloon pumps (IABPs), thus the class I recall of Arrow International devices was bad news for patients.
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