Filtering by Category: POC

The Apple Watch’s ECG features are live

The Apple Watch has a new free software update that allows for wrist-based ECGs on-the-go. Each ECG recording is saved in an iPhone app and can be shared as a PDF with physicians. The watch will also track a person’s pulse in the background and send the wearer a notification if it detects a possible atrial fibrillation, the most common form of irregular heart rhythm.

Categories: diagnostics, POC

Published on by Winnie So. Source.

HPV Tests in Your Mailbox

Screening women for HPV, or human papillomavirus, is a promising way to help detect cervical cancer early, but many at-risk women go without screening for the virus and without Pap tests that look for abnormal cells on the cervix.

A new study from The Ohio State University found that mailing at-home HPV tests to hard-to-reach women may be a viable approach, one that could be especially helpful in regions such as Appalachia, where access to women’s health care can be limited.

The study, which appears in the journal Sexually Transmitted Diseases, found that almost 80 percent of women who received the kits used them and sent them back to the researchers for testing. About a quarter of them tested positive for a cancer-causing type of HPV.

Categories: diagnostics, POC
Tags: HPV, cervix, cancer

Published on by Winnie So. Source.

Eko AI study demonstrates accurate digital diagnoses of pediatric heart murmurs without a specialist

Eko’s handheld device, the Duo, combines a digital stethoscope and electrocardiogram and was cleared by the FDA in June 2017. Eko has now developed a machine-learning AI that can detect heart murmurs in pediatric patients as accurately as a cardiologist. After receiving regulatory approval, Eko plans to roll out this new AI feature on the Duo.

Categories: diagnostics, POC
Tags: cardiac

Published on by Winnie So. Source.

MedTech Butterfly Network nets $250M to start shipping ultrasound-on-chip

Butterfly Network has raised US$250 million in series D financing to fund the manufacturing and shipping of its hand-held ultrasound devices. Its Butterfly iQ device is a pocket-sized ultrasound transducer that is plugged into an iPhone, and it received FDA approval in October 2017 for 13 applications. The iQ system is priced at less than US$2,000, compared to traditional machines that range between US$25,000 to US$250,000.

Categories: diagnostics, POC, finance
Tags: ultrasound

Published on by Winnie So. Source.

Diassess to get up to $21.9M from the feds to develop its at-home flu diagnostic

Diassess formed a five-year partnership with the Biomedical Advanced Research and Development authority to accelerate its development of its professional flu diagnostic for the clinic as well as to develop an at-home flu diagnostic test. The consumer-focused test will include a smartphone app that will link users to treatment options.

Diassess aims to provide an accurate diagnosis quickly with a nasal swab. The small, battery-powered device would analyze the sample and detect the virus’ genetic information to determine a diagnosis of influenza A or B in under 20 minutes.

Diassess is also developing DNA-based diagnostics for sexually transmitted infections, dengue and Zika fever, and other respiratory illnesses.

Categories: diagnostics, POC

Published on by Winnie So. Source.

Abionic bags $21M to trial rapid test of sepsis risk

Abionic has raised US$21 million to trial a test designed to give physicians rapid insights into patients that are at risk of sepsis. The test builds on Abionic’s work to develop an immunoassay platform that delivers results faster than the traditional laboratory-based process.

“We have the capacity to run most of the immunoassays that are today realized in laboratories in between two and three hours … on our platform in less than five minutes from a drop of a blood, instead of several milliliters of blood,” founder Nicolas Durand said.

Abionic has run several clinical studies of the platform in its first chosen field, allergy test; and has yielded commercial tests.

Categories: diagnostics, POC
Tags: sepsis, allergy

Published on by Winnie So. Source.

Alere pays $33M to settle claim it knowingly sold unreliable devices

Alere is paying the U.S. $33.2 million to settle claims it knowingly sold unreliable point-of-care testing devices to emergency departments. The government alleges Alere continued to sell Triage devices in the years running up to a 2012 recall despite receiving reports of erroneous results.

The false negatives and positives may have led patients with suspected heart failure, drug overdose and other serious conditions to receive inappropriate clinical management. 

Alere sold its Triage line to Quidel last year to obtain antitrust approval for its takeover by Abbott.

Categories: diagnostics, POC, lawsuit
Tags: Alere, FDA, cardiac

Published on by Winnie So. Source.

Biosensorix pens pact to develop rapid dengue, stroke tests

Researchers at the Ben-Gurion University (BGU) developed an immunosensor by integrating screen-printed gold electrodes into a paper lateral flow strip. It is able to deliver qualitative and quantitative results within 15 minutes while keeping costs down.

Through BGN, which handles technology transfers for BGU, Biosensorix gained access to the technology and is now working to apply it to the detection of dengue NS1 protein. The second condition to be developed is for stroke - assessing the severity of stroke and detecting secondary stroke early.

Biosensorix expects the tests to cost $5 per test kit.

Categories: diagnostics, POC

Published on by Winnie So. Source.