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.

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.

In the first patenting to have been published in the name of Lo Biosciences Inc., the company’s co-founder and CEO Sasank Vemulapati seeks further protection for their development of a device and method that helps eliminate time, distance, and cost as barriers between patients and their next blood test, by allowing patients to collect laboratory quality blood samples at home without the assistance of any health care professionals.

Just seven months after in-licensing ocedurenone (KBP-5074) from KBP Biosciences Pte. Ltd. in a $1.3 billion deal, Novo Nordisk A/S halted its late-stage study after ocedurenone failed to significantly control hypertension in chronic kidney disease patients.

Two days before the PDUFA date, the U.S. FDA handed down a complete response letter (CRL) for Rocket Pharmaceuticals Inc.’s Kresladi (marnetegragene autotemcel), delaying potential approval of the lentiviral-based gene therapy as the first therapeutic option for leukocyte adhesion deficiency type I, a rare, inherited immune disorder. But the Cranbury, N.J.-based company has suggested that delay won’t be long, as the CRL requests only “limited” chemistry manufacturing and controls (CMC) information – additional CMC data were also cited as the reason for the three-month review extension earlier this year.

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.

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.

In a 5-4 decision June 27, the U.S. Supreme Court scuttled a Purdue Pharma LP’s bankruptcy plan that would have discharged any claims against the Sackler family, which owned and controlled the company that made billions of dollars from its sales of Oxycontin (oxycodone).

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.