AliveCor is rolling out a new credit-card-size personal ECG called the KardiaMobile Card. The technology, which landed FDA clearance in November, is able to take a single-lead ECG in 30 seconds.
The Bluetooth-backed technology is able to pair with a smartphone and detect six types of arrhythmias including; AFIB, Bradycardia, Tachycardia, PVCs, Sinus Rhythm with SVE and Sinus Rhythm with Wide QRS...
Insulin pump-maker Insulet has scored FDA 510(k) clearance for its Omnipod 5 Automated Insulin Delivery System for people ages 6 and up with Type 1 diabetes. The pump integrates with the Dexcom G6 continuous glucose monitor to automatically adjust insulin levels depending on blood glucose. It can be worn for up to 72 hours.
Users can control their pump and share data from an app if they have a...
The digital health sector had a huge funding year in 2021, with Silicon Valley Bank reporting health tech companies scored nearly $40 billion, double 2020's total.
As more of these companies move out of the growth stages, how will healthcare providers get reimbursed for using their technologies? And what's the state of the reimbursement landscape right now?
"So I would typify it as better than...
Late last year, virtual reality therapeutic company AppliedVR scored FDA De Novo clearance for its EaseVRx system for treating chronic lower back pain.
The eight-week virtual reality program is designed to help people control and modulate their pain, AppliedVR cofounder and CEO Matthew Stoudt told MobiHealthNews. The system uses regulation and mindfulness skills, as well as techniques from...
Qure.ai scored FDA 510(k) clearance for its artificial intelligence algorithm that assists providers in placing breathing tubes.
The clearance, which officially came down in late December, is the company's third 510(k). The two previous FDA green lights were regarding its brain CT scan product.
Using chest x-rays, the qXR-BT algorithm can analyze the position of the breathing tube. It automates...
The German Federal Institute für Drugs and Medical Devices (BfArM) has added a new digital therapeutic to its digital health applications (DiGA) directory for public reimbursement.
Cara Care is the first DiGA that addresses gastroenterological issues and widespread digestive health problems such as Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), food and reflux intolerances.
The...
Consumer genetics company 23andMe scored FDA 510(k) clearance for a test to detect a hereditary marker for prostate cancer.
The risk report provides information on whether users have the G84E mutation in the HOXB13 gene, which studies have shown can increase a person’s risk of developing prostate cancer.
This FDA greenlight marks 23andMe’s third 510(k). It also has four De Novo clearances, one of...
A jury found former Theranos CEO Elizabeth Holmes guilty of fraud Monday, wrapping up the years-long and scandal-ridden saga of a young founder whose blood-testing technology couldn’t live up to its promises.
After seven days filled with 50 hours of deliberations, Holmes, 37, was convicted of conspiracy to defraud investors and three counts of wire fraud. The jury, made up of eight men and four...
A new harmonised regulation on health technology assessment has been adopted across the EU.
The European Commission welcomed the regulation, a deliverable of the EU Pharmaceutical Strategy, which will apply from January 2025.
Work to implement the new rules will start immediately, including the setting up of the necessary governance structure and preparatory documents to ensure effective...
Prescription digital therapeutic products can improve health for the underserved, especially in the area of mental health. Apart from addressing the severe shortage of mental health professionals by increasing access to care, recent science would suggest the digital therapeutic modality can be particularly effective at treating widespread conditions, including those made worse by the pandemic....
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 _0.jpeg?itok=AKSr2ePZ "Berlin startup addresses irritable bowel syndrome and other gastrointestinal problems with a digital therapy program.")
