Updated: 5 hours 51 min ago
Thermo Fisher Scientific is developing its own COVID-19 antibody test through an ongoing, three-way collaboration with WuXi Diagnostics and the Mayo Clinic, and plans to seek international authorizations for the test over the next few weeks.
To screen COVID-19 patients for heart problems, FDA clears several ultrasound, AI devices from Philips, Eko, Caption Health
To help detect and diagnose cardiac complications, the FDA authorized devices and algorithms from Philips, Eko and Caption Health this week—which are also, in part, designed to help limit healthcare providers’ exposure to COVID_19.
The U.S. clinical testing giants Quest Diagnostics and LabCorp are broadening the availability of their COVID-19 diagnostic tests, opening up their use nationwide.
Regeneron Pharmaceuticals launched a new initiative that plans to sequence the DNA of 450,000 patients and compare the results with their health records to support the company’s drug discovery and personalized medicine efforts.
The FDA has authorized its first COVID-19 antigen test, bringing a new category of diagnostic against the disease.
The FDA authorized its first COVID-19 diagnostic test that allows a person to collect a simple saliva sample themselves, without leaving their home.
The FDA published results from the first batch of COVID-19 antibody diagnostics to have their accuracy independently evaluated by federal laboratories—starting with the 12 blood tests the agency has already authorized for emergency use against the pandemic.
Grail has secured its fourth nine-digit-plus financing round, bringing its total funding to nearly $2 billion as it looks to complete the clinical testing of its cancer-seeking blood test.
AdvaMed launched an online platform to put ventilator manufacturers in touch with potential suppliers of much-needed components, as more companies pivot toward the coronavirus pandemic, including aerospace and defense companies.
Fitbit plans to cast a broad, digital net to catch the signs of irregular heart rhythms, using its myriad fitness trackers. The large-scale, virtual clinical study will form a key part of the company’s efforts aimed at detecting atrial fibrillation and reducing the risk of stroke, as it looks to compete with heartbeat-tracking and ECG-enabled consumer wearables such as the Apple Watch.
After allowing unreviewed antibody tests to pervade the U.S. market for weeks, the FDA is closing its open-door policy for coronavirus blood serology tests—bringing their oversight more in line with the molecular diagnostics used to confirm active cases of COVID-19.
Come on in, the water’s warm. After billions already raised by VC firms since the advent of the pandemic for life science companies, Oberland Capital has tossed more than $1 billion into the pot.
The Centers for Disease Control and Prevention launched a wide-ranging consortium—including dozens of state and federal labs, academic research centers, non-profit organizations and industry companies—to rapidly expand the use of whole genome sequencing against the novel coronavirus.
A new, artificial intelligence-powered diagnostic was able to detect the early signs of glaucoma on the cellular level in a clinical trial, a full year-and-a-half before current testing methods.
While NASA took enterprising steps last week toward returning astronauts to the moon by 2024, it also moved forward with a more terrestrial endeavor by receiving an FDA emergency authorization for a ventilator designed for the COVID-19 pandemic.
The FDA granted an emergency green light to Roche and its previously announced antibody blood test for gauging people’s exposure and immune response to the novel coronavirus.
The National Institutes of Health kicked off what it describes as a “Shark Tank”-like effort to select and fund new diagnostic tests for the novel coronavirus, and its offering a total of $1.5 billion to be divvied up among the winners.
The FDA granted a de novo clearance to a new device from Medtronic designed to continuously filter the blood of very small children and infants receiving intensive care for severe kidney injuries.
Synaptive Medical received an FDA clearance for its slightly miniaturized and more-manageable MRI system, the second such device to receive the agency’s green light in as many months.
Mojo Vision has raised an additional $51 million for its smart contact lens project—including the development of a tiny augmented reality display that would sit just above the pupil which could help people with impaired vision better navigate their surroundings.