A trio of regulators devised a series of good machine learning practices in 2021, a key point of consideration for many algorithms that will eventually be used in thousands of medical applications in the coming years.

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.

A new non-invasive device which enables women to test themselves at home for signs of the cancer-causing human papillomavirus strains in menstrual blood, has been developed with support from the Venture Builder Incubator at the University of Edinburgh.

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.

The device industry has been clamoring for legislation that would require Medicare coverage for FDA-designated breakthrough devices, a wish that is one step closer to fulfillment as of June 27.

Applaud Medical Inc. continues to file for protection for aspects of its BRIO Enhanced Lithotripsy System, an acoustic enhancer technology which aims to eliminate ureteral stones quickly, affordably, and without the need for general anesthesia or a fluoroscopy procedure that may be conducted in a physician’s office and other non-hospital setting.