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Updated: 5 hours 51 min ago

Thermo Fisher, WuXi and Mayo Clinic to develop open-platform COVID-19 antibody test

Wed, 05/13/2020 - 08:13
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

Wed, 05/13/2020 - 07:46
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.

LabCorp, Quest broaden availability of COVID-19 tests nationwide

Tue, 05/12/2020 - 09:19
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 links with Univ. of Colorado to sequence 450,000 patients for drug research

Mon, 05/11/2020 - 07:03
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.

FDA greenlights its first coronavirus antigen test for rapid point-of-care screening

Sat, 05/09/2020 - 16:16
The FDA has authorized its first COVID-19 antigen test, bringing a new category of diagnostic against the disease.

FDA authorizes saliva-based coronavirus test for at-home use

Fri, 05/08/2020 - 13:34
The FDA authorized its first COVID-19 diagnostic test that allows a person to collect a simple saliva sample themselves, without leaving their home.

FDA publishes first validation results of 12 COVID-19 antibody tests

Fri, 05/08/2020 - 08:15
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's 4th funding round nets $390M for its cancer-seeking blood test

Wed, 05/06/2020 - 14:20
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, defense contractors team up to supply ventilator parts

Wed, 05/06/2020 - 08:33
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 launches broad virtual AFib study using all its heart-tracking devices

Wed, 05/06/2020 - 07:00
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.

FDA increases oversight, requirements for COVID-19 antibody tests

Tue, 05/05/2020 - 08:00
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.

Oberland Capital nabs $1.05B raise for late-stage plays, handing out cash for royalties

Tue, 05/05/2020 - 03:29
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.

CDC launches nationwide public-private effort to coordinate coronavirus sequencing

Mon, 05/04/2020 - 08:00
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.

Using AI and dyes, a new eye test spots glaucoma 18 months early in a clinical study

Mon, 05/04/2020 - 07:12
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.

FDA authorizes NASA-designed ventilator for COVID-19

Sun, 05/03/2020 - 13:46
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.

Roche's COVID-19 antibody test nets FDA emergency authorization

Sun, 05/03/2020 - 13:05
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.

NIH begins taking pitches for its $1.5B COVID-19 diagnostics competition

Fri, 05/01/2020 - 07:04
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.

Medtronic's blood filtering machine cleared for the smallest children

Thu, 04/30/2020 - 14:58
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.

FDA clears Synaptive’s smaller, point-of-care MRI scanner

Thu, 04/30/2020 - 07:53
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 sees $51M round for its smart, vision-improving contact lens

Wed, 04/29/2020 - 08:33
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.