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BioWorld - Tuesday, December 30, 2025
Home » Topics » U.S., BioWorld MedTech

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Physician using an Ipad

Nanthealth looks to help cancer patients during pandemic

May 13, 2020
By Liz Hollis
How is the COVID-19 pandemic affecting cancer treatment plans? Oncologists are weighing switching treatment plans, and they have many questions. That’s where Nanthealth Inc., of El Segundo, Calif., is looking to help.
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Digital illustration of U.S., coronavirus
World Medical Innovation Forum

U.S. COVID-19 Dx: Lack of centralization meets flourishing innovation, as disorder prevails

May 13, 2020
By Stacy Lawrence
The U.S. does not have a universal health care system, which means that it fails to provide a consistent level of minimum care across its population. That means that basic and preventative care often falls through the cracks, even as the U.S. continues to excel at medical innovation and offer the most highly regarded health care in the world to those who can afford it.
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HD-X system

Quanterix says COVID-19 antibody test with Simoa platform has 1,000x greater sensitivity than current tests

May 12, 2020
By Meg Bryant
Quanterix Corp., of Billerica, Mass., reported that researchers have developed a COVID-19 antibody test with 1,000 times the sensitivity of current tests using its Simoa bead-based immunoassay platform.
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Propel implant devices

COVID-19 hits Intersect ENT after good start to year

May 12, 2020
By Liz Hollis
Intersect ENT Inc., of Menlo Park, Calif., saw its revenue for the first quarter of 2020 fall to $19.8 million. That figure compares with $26.7 million for the same period last year, with the COVID-19 pandemic having a significant impact on procedures.
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NIAID Director Anthony Fauci speaking at a White House briefing

Fauci ‘cautiously optimistic’ regarding COVID-19 vaccine; Giroir projects 50M tests per month by September

May 12, 2020
By Mark McCarty
The May 12 Senate hearing regarding the COVID-19 pandemic included the usual conversations about contact tracing, but Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is “cautiously optimistic” that one of the vaccines currently in trial in the U.S. will work, but that it is unlikely a vaccine will be ready by September 2020. In contrast, Assistant Secretary for Health Brett Giroir said testing capacity may reach 50 million tests per month by that time, thanks in part to the fact that antigen testing is now part of the FDA’s emergency use authorization mechanism.
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Digital illustration of U.S., coronavirus

FTC active in litigation over advertising, promotional claims during pandemic

May 8, 2020
By Mark McCarty
The U.S. FDA’s enforcement regarding products related to the COVID-19 pandemic has picked up steam recently, but the U.S. Federal trade commission (FTC) is also involved in this enforcement arena. Leonard Gordon, a partner at Venable LLP’s New York office, told BioWorld that while the FTC and FDA missions seem to overlap, the FTC primarily targets unsupportable advertising claims rather than product labeling, a particularly relevant area in the COVID-19 pandemic.
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Emblem S-ICD product image
HRS Scientific Sessions

Data bolsters case for Boston Scientific’s Emblem S-ICD and Watchman Flx devices

May 8, 2020
By Meg Bryant
Boston Scientific Corp. reported positive results for its Emblem subcutaneous implantable defibrillator (S-ICD) system and next-generation Watchman Flx left atrial appendage closure (LAAC) device at the Heart Rhythm Society scientific sessions, which were online only this year due to the COVID-19 pandemic.
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Syringe and vial

Shortage of needles, syringes looms in race to develop COVID-19 vaccine

May 8, 2020
By Mari Serebrov
In the rush to develop a COVID-19 vaccine, integral parts of the equation are being overlooked in the U.S., according to a whistleblower complaint filed this week by Rick Bright over his removal as director of the Biomedical Advanced Research and Development Authority (BARDA). Even if millions of doses of vaccine are ready to go by January, as the NIH’s Anthony Fauci a few weeks ago said could happen, there may not be enough needles and syringes to deliver those doses.
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Dollar arrows pointing upward

Diagnostic companies see positive quarterly results in wake of COVID-19

May 7, 2020
By Liz Hollis
Several companies have reported quarterly results over the past couple of days, and those offering testing for COVID-19 have seen impressive numbers. Standing out was San Diego-based Quidel Corp., whose numbers caught the attention of William Blair’s Brian Weinstein. Indeed, its $174.7 million in revenue far exceeded his organization’s estimate of $160 million, driven by influenza.
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NIH’s Collins says need for supplies will be factored into Shark Tank grants for COVID-19 tests

May 7, 2020
By Mark McCarty
The U.S. National Institutes of Health recently announced a competitive grant opportunity for testing for the SARS-CoV-2 virus, which has been characterized as a “Shark Tank-like” program, and NIH director Francis Collins said in a May 7 Senate hearing that one of the criteria for awards is whether supplies can be made readily available for that test, the lack of which has been a significant impediment to testing in the U.S.
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