The U.S. FDA’s September 2022 guidance for clinical decision support (CDS) software was controversial the moment the agency posted the document, prompting the filing of a citizen’s petition five months later. The CDS Coalition has penned a June 8 letter to FDA commissioner Robert Califf in an effort to draw a reaction from the agency, but the letter was accompanied by a summary of an analysis of CDS software with a machine learning (ML) component that suggests that such products that are in development may have to be reconsidered.

The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.

There is a growing body of evidence showing prescription digital therapeutics (DTx) are effective, but slow progress in agreeing reimbursement and integrating them into care pathways is limiting access for patients and holding back commercial development in Europe.

China continues to ramp up efforts to digitize its health care system, as it moves closer toward a 2025 deadline that is part of a nationwide plan. Several of the country’s largest tech conglomerates now have digital health operations that are beginning to show profits and are expected to grow significantly over the next decade.

Researchers at Mount Sinai Hospital have demonstrated that a machine learning-based model enables medical institutions to predict mortality risk for individual cardiac surgery patients.

Biosency SA's Bora Care remote monitoring solution can predict acute chronic obstructive pulmonary disease (COPD) exacerbations on average three days prior to hospitalization, according to initial results from an ongoing study. The results show that the technology can help prevent hospital admission and reduce the severity of acute exacerbation of COPD (AECOPD) leading to a better quality of life for COPD patients.

A financial freefall left prescription digital therapeutic pioneer Pear Therapeutics Inc. cut into four pieces following a bankruptcy judge’s approval of the sale of its assets for a total of $6.05 million. Sleep-focused Nox Health Group took the biggest bite, acquiring the FDA-cleared Somryst PDT for $3.9 million. Other buyers included Harvest Bio LLC, Click Therapeutics Inc. and Welt Corp. Ltd. The total generated from the assets was woefully short of the company’s $32 million in debt.

The researchers who enabled patients with spinal cord injuries to walk independently after implanting programmable electrodes below their lesions have now taken things one step further, restoring direct communication from the brain to the spinal cord, enabling the brain rather than an external computer to direct leg movements.

The researchers who enabled patients with spinal cord injuries to walk independently after implanting programmable electrodes below their lesions have now taken things one step further, restoring direct communication from the brain to the spinal cord, enabling the brain rather than an external computer to direct leg movements.