PERTH, Australia – Australian digital health company Resapp Health Ltd. was down nearly 52% following news that the U.S. FDA rejected its de novo request for its smartphone application for the diagnosis and management of respiratory disease. The agency rejected the application, citing the need for additional information to demonstrate that the “clinical benefits of the device outweigh the risks,” CEO Tony Keating told analysts during a March 12 conference call on the news.

PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Aug. 25, 2020, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).

HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic kits to battle the pandemic in the country, which is home to one of the largest outbreaks in the world outside of China.

As companies scramble to develop diagnostic tests and vaccines for COVID-19, there is a need for effective treatments for patients suffering severe respiratory effects from the novel coronavirus. To that end, Beyond Air Inc., of Garden City, N.Y., and Rehovot, Israel, has applied to the U.S. FDA to conduct an IDE trial of its inhaled nitric oxide (NO) system, Lungfit Bro, in COVID-19 patients.

LONDON – Behold.ai Ltd. has secured U.S. FDA 510(k) approval for use of its Red Dot image recognition algorithm in the automatic diagnosis of life-threatening pneumothorax (collapsed lung). The product completes the analysis immediately, sending an alert to the radiologist as soon as an X-ray is taken. “It does in 30 seconds what would normally take up to 30 minutes,” said Simon Rasalingham, CEO of London-based Behold.ai.

Endologix Inc., of Irvine, Calif., has won approval from the U.S. FDA for its Alto abdominal stent graft system, the company’s next-generation Ovation system for polymer endovascular aneurysm repair (EVAR). The company plans to begin rolling out Alto initially to high-volume customers of its Ovation iX system, who are already skilled at using Ovation stent grafts.

The U.S. effort to deploy diagnostics for the novel coronavirus has been plagued by missteps by the CDC and the FDA from the outset, leading to delays and missed opportunities. The Trump administration declared a national emergency March 13, but concerns remain about how quickly the array of available tests can be conducted and whether there are enough testing supplies to handle the anticipated demand.