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.

The U.S. FDA reissued a 2022 draft guidance for clinical trial diversity at the behest of legislation from Congress, ballooning the previous nine-page draft to 23 pages.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.

Researchers from the University of South Florida developed a novel ventricular assist device that is placed directly inside a failing ventricular cavity to help it pump blood correctly again. This device consists of a self-expanding stent that contains a sac and inlet/outlet ports that allow compression fluids to generate contractile forces that pump the blood out.

The U.S. FDA granted approval of Verona Pharma plc’s ensifentrine on its PDUFA date of June 26, giving the chronic obstructive pulmonary disease (COPD) community its first new mechanistic option in a decade. The drug, branded Ohtuvayre, is also the first inhaled nonsteroidal therapy to treat a respiratory disease that combines both a bronchodilator and anti-inflammatory mechanism into one molecule. It is indicated for the maintenance treatment of COPD, which Verona said allows for broad use.