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Connecticut-based Tangen has raised $9 million in a series A round to put the company’s TangenDx platform into the clinic in two trials focused on obtaining FDA clearances in diagnosing infectious diseases and commercialize in 2020. TangenDx is a DNA/PCR-based test system that is battery-powered and delivers results in less than one hour.
Abbott launched its new point-of-care diabetes blood test, the Afinion HbA1c Dx test. It can provide hemoglobin A1c results in 3 minutes, allowing clinicians to develop and start care plans within a patient’s single visit to the doctor’s office.
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.
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.
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.
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.
MeMed aims to reduce the misuse of antibiotics with its point-of-care immune system diagnostic that distinguishes between bacterial and viral infections. It will also allow measurement of multiple other proteins and signatures to diagnose and manage patients across a wide range of diseases.
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.
Orion is set to sell its diagnostic unit to private equity group Axcel Management for around US$200 million upfront. The deal will give Axcel control of a portfolio of in vitro diagnostics and point-of-care testing systems that generated sales of $66 million last year.
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.