As Johnson & Johnson (J&J) made public the launch of a phase III trial with its COVID-19 vaccine, officials from the company and others at the virtual Biopharm America meeting discussed modes of innovation in the pandemic era.

Children with autism spectrum disorder (ASD) can face a lifetime of frustration because of challenges with communication, social behaviors and flexibility of thought. Early intervention can improve outcomes, but nailing a diagnosis of ASD often takes years. Cognoa Inc. wants to change that with its digital ASD Diagnostic and is on track to apply for U.S. FDA clearance before the end of the year.

Two studies seek to answer the most pressing question for physicians examining a patient with COVID-19: What's this person's risk of death? Mount Sinai researchers presented their clinical prediction model in The Lancet Digital Health and a team from Johns Hopkins published their risk calculator in the Annals of Internal Medicine.

HONG KONG – Seoul, South Korea-based Vuno Inc. reported that it plans to list on South Korea’s Kosdaq bourse either by the end of 2020 or early next year, CTO and cofounder Kyu-hwan Jung told the 2020 Bioplus Interphex Korea Conference. After receiving A ratings in the recent technology evaluations by assessment institutions NICE D&B and Korea Enterprise Data, Vuno submitted a preliminary examination application to the bourse on July 28 that is currently underway, the company said.

As Johnson & Johnson (J&J) made public the launch of a phase III trial with its COVID-19 vaccine, officials from the company and others at the virtual Biopharm America meeting discussed modes of innovation in the pandemic era.

Pear Therapeutics Inc. has seen its efforts in the prescription digital therapeutics (PDT) space come to fruition with two new deals reported this week. The Hartford Financial Services Group Inc. now covers two of the company's therapeutics – Reset, for substance use disorder, and Reset-O, for opioid use disorder – for its employees and their beneficiaries. Preferredone will also cover the two PDTs for all its members.

The field of artificial intelligence (AI) is stretching the boundaries of conventional med-tech regulation, and several regulatory agencies are working to cut that Gordian knot. Marc Lamoureaux, director of digital health at Health Canada’s (HC) medical device directorate, said on a Sept. 21 webinar that legislation passed in 2019 gives the agency a “regulatory sandbox” in which to experiment with AI regulation, a mechanism he said may bring these algorithms to market much more rapidly than would otherwise be the case.

The digital medicine company Physiq Inc. has received a contract from the NIH to develop an artificial intelligence (AI)-based index that can provide an early warning that a patient with COVID-19 is in decline and needs medical treatment. The index, called the COVID-19 Decompensation Index (CDI) Digital Biomarker, will run on Physiq’s existing Accelerateiq computing platform, analyzing physiological data from FDA-cleared wearable devices to create a personalized baseline for patients who have tested positive for COVID-19.