PARIS – April 2020 was a milestone month for the key players in interventional cardiology in France. The reimbursement system in France is finally opening its doors to the drug-eluting balloon (DEB), following years in the wilderness.

Bio-Rad Laboratories Inc. has launched its SARS-CoV-2 Total Ab test, which is a blood-based assay to identify all the antibodies that are developed by the human body in response to the novel coronavirus SARS-CoV-2. Companies have been racing to offer serological tests that work to detect the antibodies developed during a COVID-19 infection that remain present in the blood after the initial infection clears.

The COVID-19 pandemic has gripped the conversation regarding diagnostic and surveillance testing, but stakeholders nonetheless saw fit to populate the docket for the FDA’s proposal to down-classify tests for the human immunodeficiency virus (HIV) to class II. One of the themes of the feedback was that the proposal excludes a few key items, such as quantitative nucleic acid tests and testing for viral load monitoring, leaving the FDA with some difficult decisions to make.

TORONTO – Within a week of completing clinical trials the chest radiography AI tool developed by Vancouver, B.C.-based 1Qbit Inc. has been given the all-clear from Health Canada for deployment across the country. The XrAI was originally developed to better identify patients with respiratory illness including SARS, pneumonia and tuberculosis (TB), but then in February was tested on a publicly available data set of COVID-19 X-ray images.

Artificial intelligence-focused Chronolife SAS, of Paris, has secured class IIa medical certification from the EU for its smart T-shirt, which has the new brand name Keesense. The reusable, washable T-shirt is designed for comfortable, round-the-clock use. It works by transmitting data to a paired smartphone app via Bluetooth.

Carmell Therapeutics Corp., of Pittsburgh, received fast track designation from the U.S. FDA for its first product, CT-101, a bone healing accelerant. Carmell is gearing up for a phase III study of the plasma-based bioactive accelerant as part of its pursuit of a biologic license application.

The FDA’s 15-day deadline for responses to warning letters has long been a sore spot for device makers, who might argue that some of the more complex regulatory findings require more than 15 days to analyze and address. That same timeline was found in both the draft and final versions of the non-binding feedback guidance for device inspections despite industry’s pleas that such a tight deadline leads to rushed judgment and potentially inadequate responses by managers at the manufacturing site.