FDA

Also: FDA pushes back on Nanox's "digital X-ray" 510(k) and clears B-Secur's ECG algorithms.

Also: Cleo names three new leadership positions. 

As the agency's workload swells with the weight of a public health emergency, digital health companies on a timeline should consider whether their products truly warrant a regulatory submission, writes Epstein Becker & Green's Bradley Merrill Thompson.

Alongside step-by-step instructions, the Ellume COVID-19 Home Test's accompanying app automatically reports users' results to the relevant public health authorities.

The new version will expand the classification range up to 150 beats per minute.

Mahana Therapeutics' Parallel is a three-month digital treatment that logs patients' symptoms to deliver relevant guidance and teach them condition-management skills.

Lucira's molecular testing kit allows individuals to collect their own nasal sample and insert it into a device that provides results in under 30 minutes. The company is aiming to sell the single-use tests for roughly $50.

NightWare's digital therapeutic monitors a wearer's heart rate and movement to detect disturbances during sleep, and delivers gentle vibrations to interrupt a nightmare without waking the user.

Quantib and Ezra's automated tools support diagnosis and measurement of the prostate and prostate lesions, while Aidoc's algorithm acts as an always-on catch net for unsuspected blockage of pulmonary arteries.

More expertise will be necessary if the regulator is to keep up with the constant evolution of real-world evidence, privacy and other data-driven challenges, Dr. Hahn said.