The FDA has granted Anchordx Medical Co. Ltd.’s Urifind, an early detection test for bladder cancer, a breakthrough device designation (BTD). This marks the first BTD given to a liquid biopsy test for bladder cancer detection in China, putting it in good stead as it gears up for an IPO.

Memic Innovative Surgery Ltd. agreed to combine with Medtech Acquisition Corp. in a transaction expected to close in the fourth quarter of 2021. The deal establishes an eye-popping $1 billion pro forma valuation for the company, which received FDA clearance for its first device just four months ago.

A change of presidential administrations often brings a significant change in regulatory policy, and the Granston memo did just that shortly after the Trump administration took office in 2017. However, the Department of Justice (DoJ) has dismissed fewer whistleblower (qui tam) lawsuits against the private sector recently, a trend that Jonathan Phillips of Gibson Dunn said was evident before the Biden administration took over.

Medcura Inc. has secured $7.4 million in series A equity financing to grow its line of hemostatic and wound treatment products. Part of the proceeds from the investment will go toward further developing the company’s lead surgical candidate, Lifegel, and advancing it to clinical trials.

TORONTO – Western New York Imaging Group, a one-hour drive across the U.S.-Canadian border, will soon be the site for a hard launch of Champ, a system developed by Voxneuro Inc. that evaluates suspected cognitive brain disorder or symptoms such as fatigue, memory loss or brain fog. This comes after Voxneuro won FDA registration of the cognitive platform as a class II exempt medical license, followed last month by Health Canada approval of the system for help diagnosing concussion, traumatic brain injury and dementia.