Trying to build out a new med-tech product category is a time-consuming and costly endeavor. Senseonics Holdings Inc. has long pursued the vision of extended-use, implantable continuous glucose monitoring. Since it was founded in 1996, the Germantown, Md.-based company has already spent roughly half a billion dollars to get there.

Before becoming the global head of Johnson & Johnson External Innovation, William Hait spent 30 years in academic medicine focused on oncology. Whenever he speaks to a group, the first question he asks is if there is anyone in the room that would like to get a disease.

Zurich-based startup Ava Science Inc. recently issued a public call for partners and funding to further research the potential usefulness of its fertility wearable, known as Ava Bracelet, during the COVID-19 pandemic.

With an eye toward helping those potentially suffering from COVID-19, Mountain View, Calif.-based Alivecor Inc. said its six-lead electrocardiogram (ECG), known as the Kardiamobile 6L, now is allowed for use in the measurement of a patient's QTc and detection of QT prolongation. The Kardiamobile 6L enables patients to take a six-lead ECG outside a doctor’s office.

With the number of COVID-19 cases continuing to rise and with people social distancing and quarantining, at-home diagnostics and telehealth offer the means for doctors and patients to get vital answers and care without meeting face to face. Now, Los Angeles-based Scanwell Health has gained exclusive rights to license and distribute a rapid serology test from Innovita Biological Technology Co. Ltd., of Hebei, China, for at-home testing of SARS-CoV-2, the coronavirus that causes COVID-19.

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.

Chronic disease patients are facing serious risks both from keeping away from necessary care settings, as well as from potential COVID-19 infection. One in five chronic disease patients was already starting to avoid seeking care in physician’s offices and hospitals, according to a survey that started early last week of a panel of 1,300 chronic disease patients across several indications.

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.

Pharma has not gotten terribly serious yet about integrating digital health tools into clinical trials, let alone into their product offerings, despite the potential benefits they could offer when it comes to patient adherence, compliance and experience. Still, oncology giant Bristol Myers Squibb Co. has made a small step in that direction by partnering with Paris-based digital therapeutics company Voluntis SA.