The U.S. FDA's emphasis on device safety is well known. Now, the agency has published a draft guidance that aims to provide expedited reviews for device and diagnostic applications that are "reasonably expected to significantly improve" safety, which, in conjunction with the breakthrough devices program, suggests that many other applications will be in the queue for increasingly longer periods of time.

HONG KONG – Dreamed Diabetes Ltd., of Petah Tikva, Israel, has received both FDA clearance and the CE mark for an insulin dosing decision support software based on artificial intelligence (AI).

Chronic bronchitis affects more than 9 million people in the U.S., but current treatments fail to address the overproduction of mucus. Gala Therapeutics Inc., of Menlo Park, Calif., is looking to change that.

The FDA granted breakthrough device status to Prescient Metabiomics' Lifekit Prevent colorectal neoplasia test. Prescient Metabiomics is a subsidiary of Carlsbad, Calif.-based Prescient Medicine Holdings Inc.

Glaxosmithkline plc has won FDA approval to market Nucala (mepolizumab) for use in children as young as 6 with severe eosinophilic asthma (EA). The therapy already had FDA approval as an add-on maintenance treatment for kids with the same condition ages 12 and older. Approval of the sBLA, submitted last November, catches the U.S. market up to the EU, where Nucala has been approved as an add-on treatment for children ages 6 to 17 since August 2018.

It's been a busy September for Ardelyx Inc. so far. Less than two weeks after the Fremont, Calif-based company reported promising pivotal data for tenapanor in chronic kidney disease patients with hyperphosphatemia, the sodium hydrogen exchanger 2 (NHE3) inhibitor won FDA approval for use in irritable bowel syndrome with constipation (IBS-C).

The FDA has granted breakthrough device designation to Sonivie Ltd.'s Therapeutic Intra-Vascular Ultrasound (TIVUS) system for the treatment of pulmonary arterial hypertension (PAH). Early clinical studies suggest that the catheter-based system could stabilize or reduce pressure in the pulmonary vasculature of PAH patients, a population with an average survival rate of five years.

Irvine, Calif.-based Axonics Modulation Technologies Inc., which has developed an implantable rechargeable sacral neuromodulation (r-SNM) device for the treatment of urinary and bowel dysfunction, has won the FDA's nod for its system to help patients with fecal incontinence.

Santa Clara, Calif.-based Shockwave Medical Inc. is working to build its business around the use of intravascular lithotripsy (IVL) in multiple arterial indications. Lithotripsy has been used to destroy kidney stones for decades, but now Shockwave's system is applying that technology to indications including coronary artery disease (CAD), above-the-knee peripheral artery disease (PAD) and below-the-knee PAD that each require a specific catheter.