October 1, 2019
Sixth time's the charm? Roche’s Accu-Chek Connect Diabetes Management App has notched its sixth device recall from the FDA, this time due to meter-to-app data transfer issues for users with Android OS 8.0 and above. According to the agency’s posting, Roche notified partners, users and call centers of the issue and released and update addressing the problem before the end of that month.
January 2, 2019
Clearance expands BrainScope's use cases. Bethesda, Maryland-based BrainScope has received FDA clearance for new labeling for its BrainScope One system, a wearable mobile device that helps medical professionals assess traumatic brain injury. Specifically, the new labelling expands the product's indications for use to include “multi-modal, multi-parameter assessment” of “concussion” and “mild...
September 4, 2018
Top-line data from the latest trial of ResApp’s smartphone-based diagnostic algorithm for respiratory diseases suggest that the machine learning tool’s conclusions generally align with clinical diagnoses when employed for younger patients.
The double-blind, prospective Breathe-Easy pediatric study was conducted among a cohort of 585 Australian children whose ages ranged from 29 days to 12 years,...
Photo by Luke Sharrett, Getty Images
August 22, 2018
Brisbane, Australia-based ResApp has signed a deal to join in the development of mobile applications that will help determine the mission-readiness of American military personnel.
ResApp, which creates smartphone apps for the diagnosis and management of respiratory diseases, has announced a partnership with aerospace giant Lockheed Martin to join the US Government’s Warfighter Analytics using...
April 12, 2018
Brisbane, Australia-based ResApp Health, a digital health company that specializes in diagnosing respiratory diseases, is now conducting clinical proof-of-concept studies for its latest technology that uses a smartphone to detects sleep apnea by sound.
Preliminary results from a clinical trial released by ResApp found that the technology achieved an 86 percent sensitivity and 83 percent...
December 19, 2017
Brisbane, Australia-based ResApp is planning to re-do its big US trial soon, but in the meantime the smartphone respiratory diagnosis company is continuing to collect data in its native country.
The company released data yesterday from a clinical study of more than 1,300 adult patients at Joondalup Health Campus in Perth and Wesley Hospital in Brisbane. While the company’s previous studies have...
November 21, 2017
Brisbane, Australia-based ResApp intended to have its software, which uses a smartphone microphone to diagnose respiratory conditions based on coughs, well on its way through the FDA by now. But this past summer, the company’s big plans hit a major setback when the data came back from its landmark clinical trial, conducted at such austere institutions as Massachusetts General Hospital, Cleveland...
August 30, 2017
Outcome Health, which equips providers with screens displaying educational content, has added its first chief engineering officer to its ranks. Nandini Ramani, who most recently served as VP of Engineering at Twitter, will assume the post.
"Healthcare is an industry close to my heart and Outcome Health's impact on society is tangible and meaningful," Ramani said in a statement. "In addition to...
August 9, 2017
Brisbane, Australia-based digital health company ResApp has been talking up its Smartcough-C study — a multisite, double-blind study of the company’s smartphone-based respiratory analysis software — for a number of months. Conducted at Massachusetts General Hospital, Cleveland Clinic, and Texas Children’s Hospital, the trial was intended to support ResApp’s FDA submission for a number of...
May 12, 2017
Virtual medical assistant company Sensely is collaborating with the Mayo Clinic to ascertain how to leverage patient engagement and chronic disease monitoring technology. The partnership will blend the Mayo Clinic’s triage algorithms and clinical expertise with Sensely’s patient engagement platform in hopes of assessing and predicting which resources can be best used at the right time to help...