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BioWorld - Saturday, March 28, 2026
Home » Topics » Medical devices » Digital health

Digital health
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Novo Nordisk - Novopen Six

Novo Nordisk wins first smart insulin pen approval for diabetes in China

Sep. 28, 2022
By Doris Yu
Novo Nordisk A/S received marketing approval from China’s NMPA for its smart insulin pen Novopen Six that automatically collects and stores the date and time of injections and the number of units of insulin that users take.
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Telehealth illustration

Home monitoring leads to lower death, rehospitalization rates for French HF patients

Sep. 9, 2022
By Bernard Banga
The association of health care professionals in Normandy (APRIC) and the regional support group for the development of e-health in Normandy released new data on the importance of home telemonitoring in heart failure. Patients participating in the Suivi Clinique à Domicile (SCAD) heart failure home telemonitoring program experience less re-hospitalizations and lower death rates than patients with the same pathology but not on the program.
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FDA draft for digital tech in clinical trials languishes despite agency’s digital push

Sep. 2, 2022
By Mark McCarty
The U.S. FDA’s formation of the Digital Health Center of Excellence was heralded as a key enabler of digital health technologies, but the news hasn’t necessarily had the expected effect. The agency’s December 2021 draft guidance on the use of digital health technologies to assist in the conduct of clinical trials is still in regulatory drydock.
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Brain anomalies identified by the MELD AI algorithm

AI detects anomalies responsible for epilepsy seizures

Sep. 1, 2022
By Bernard Banga
International research project Multicentre Epilepsy Lesion Detection (MELD), led by University College London, has developed artificial intelligence software that can identify minute brain anomalies that lead to epilepsy seizures. These anomalies, known as focal cortical dysplasia, can often be treated with surgery but are difficult to visualize on an MRI.
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U.S. at night from space with circuit board overlay

FDA draft for digital tech in clinical trials languishes despite agency’s digital push

Sep. 1, 2022
By Mark McCarty
The U.S. FDA’s formation of the Digital Health Center of Excellence (DHCoE) was heralded as a key enabler of digital health technologies, but the news hasn’t necessarily had the expected effect. The agency’s December 2021 draft guidance on the use of digital health technologies to assist in the conduct of clinical trials is still in regulatory drydock.
Read More
NuraLogix blood biomarker

Nuralogix AI scans faces to predict glucose levels

Aug. 31, 2022
By Annette Boyle
Nuralogix Corp. has trained machine learning models to interpret blood flow patterns in facial scans to predict whether an individual has prediabetes. The model runs on a smartphone app, which could increase awareness of the risk of developing diabetes in a significant portion of the population.
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European Society of Cardiology 2022

Study boosts potential of smartphones to screen for atrial fibrillation

Aug. 30, 2022
By Mark McCarty
Medical science has been experimenting with smart devices for several years to determine whether these products can detect circulatory system diseases, and a study presented at the 2022 meeting of the European Society of Cardiology (ESC 2022) seems to strongly suggest that the answer is a resounding yes. The eBRAVE-AF study of more than 5,500 enrollees of middle age or older demonstrated the ability of a smartphone camera and a downloadable app to at beat conventional screening for atrial fibrillation (AF), a finding that could save lives and boost the prospects of device makers in the digital health space.
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Cue Care Antiviral

Cue Health Inc. offers test-to-treatment service for COVID-19

Aug. 29, 2022
By Annette Boyle
Cue Health Inc. rolled out a same-day, at-home, test-to-treatment program through its Cue Health app for any patient in the U.S. with a positive result from its COVID-19 test. The service includes a virtual, on-demand visit with a health care professional to discuss the test result; a prescription for medication to treat the virus, if appropriate; and home delivery of the medication, typically within hours of the visit. Medications may also be made available for pickup at a local pharmacy.
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Woman using smartphone

German doctors reluctant to prescribe health apps

Aug. 26, 2022
By Bernard Banga
German regulators have unveiled their initial report covering the prescription and deployment of reimbursable health apps. The survey was carried out by Hamburg-based health insurance fund Techniker Krankenkasse (TK) in conjunction with Bielefeld University in North Rhine-Westphalia and health care economics analysis research bureau Vandage GmbH, also based in Bielefeld.
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Cumulus study shows utility of home-based EEG

Aug. 24, 2022
By Nuala Moran
Cumulus Neuroscience Ltd. published a study demonstrating its home use electroencephalogram (EEG) can turn in more precise results than supervised laboratory-based assessments.
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