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 Now, the agency has published a draft guidance that aims to provide expedited reviews for device and diagnostic applications that are "reasonably expected to significantly improve" safety, which, in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.

Melbourne, Australia-based regenerative medicine company Avita Medical Ltd. has received good news from the FDA. The company, which also has a presence in Valencia, Calif., said the agency gave its thumbs up to an investigational device exemption application for a pivotal trial (NCT04091672) evaluating the safety and effectiveness of the Recell autologous cell harvesting device in combination with meshed autografting for the treatment of acute full-thickness skin defects, such as degloving, crush wounds, abrasions, lacerations and surgical wounds.

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.

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.

BEIJING – The ongoing trade war between the U.S. and China has helped put the biotechnology field on the U.S. foreign investment restriction list, causing a chilling effect on the market. With the amount of Chinese money entering the U.S. biotech sector dropping sharply, many believe it is the U.S. that is taking the hit.

The U.S. FDA has granted breakthrough device designation to Laboratory for Advanced Medicine Inc. (LAM) for its liquid biopsy blood test for the detection of liver cancer. The test, which analyzes the DNA methylation pattern of cell-free DNA (cfDNA), is designed to detect the presence of hepatocellular cancer as early as stage 1, with both high specificity and sensitivity.