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Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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U.S. Capitol building

U.S. HHS projects national daily COVID-19 testing needs at 300,000, but Democrats unimpressed

May 26, 2020
By Mark McCarty
The U.S. Department of Health and Human Services (HHS) has posted a national COVID-19 testing strategy in response to legislation passed in April, and the plan suggests that 300,000 tests per day should suffice to corral the pandemic. That calculation drew immediate fire from House and Senate Democrats, who characterized the plan as an attempt “to paint a rosy picture about testing,” but they also pushed the Senate to pass House legislation that would provide another $75 billion in funding for testing and contact tracing.
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Phase I/II trial evaluates LS-301 uptake in breast cancer patients

May 25, 2020

Fidget spinner allows point-of-care diagnosis of UTIs

May 25, 2020
U.S. FDA headquarters

FDA says 28 serology tests withdrawn or pulled from availability in the U.S.

May 22, 2020
By Mark McCarty
The U.S. FDA reported that 28 serology tests for antibodies for the SARS-CoV-2 virus either have been withdrawn from the market by the sponsor or delisted by the agency for failure to comply with its notification process for emergency use authorization (EUA). The agency said the list of unavailable tests will be updated over time. For his part, Commissioner Stephen Hahn said the move was undertaken “to ensure that Americans have access to trustworthy tests.”
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Person holding knee, joint pain

Plan with the golden arm deals Navidea phase II imaging win in RA

May 22, 2020
By Randy Osborne
Navidea Biopharmaceuticals Inc. CEO Jed Latkin said positive findings from the second interim analysis of the phase IIb study called NAV3-31 “were certainly better than what we were looking for” and will “make our partnering discussions a lot more interesting.”
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Drug capsules, broken chain over world map

Pandemic leaves no room for weak link in the supply chain

May 22, 2020
By Mari Serebrov
Scaling up to manufacture a massive volume of a COVID-19 vaccine, drug or innovative device that’s still in early stage development is easier said than done, especially in a global pandemic that has the supply chain stretched beyond capacity.
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3D illustration of virus with RNA inside

Mammoth Biosciences, GSK team up on CRISPR-based COVID-19 test

May 22, 2020
By Meg Bryant
Mammoth Biosciences Inc., of South San Francisco, and London-based Glaxosmithkline plc (GSK) have joined forces to develop a point-of-care test to detect active COVID-19 infections using Mammoth’s CRISPR-based DETECTR platform. The two companies hope to submit an application to the U.S. FDA for emergency use of the test before the end of the year.
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Navidea reports second interim analysis from phase IIb study of Tc99m tilmanocept imaging in RA

May 22, 2020
3D illustration of virus with RNA inside

Mammoth Biosciences, GSK team up on CRISPR-based COVID-19 test

May 21, 2020
By Meg Bryant
Mammoth Biosciences Inc., of South San Francisco, and London-based Glaxosmithkline plc (GSK) have joined forces to develop a point-of-care test to detect active COVID-19 infections using Mammoth’s CRISPR-based DETECTR platform. The two companies hope to submit an application to the U.S. FDA for emergency use of the test before the end of the year.
Read More
Early cavity detection (ECD) system product image

Ortek fills cavity in dental care with early caries detection system

May 21, 2020
By Annette Boyle
Ortek Therapeutics Inc., of Roslyn Heights, N.Y., has officially launched its electronic early cavity detection system, the Ortek-ECD. The U.S. FDA-cleared device can detect dental lesions before they show up on X-rays, enabling less invasive treatment and preventing greater damage to the tooth structure. Ortek holds the exclusive license for the device which was developed at Stony Brook University School of Dental Medicine.
Read More
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