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BioWorld - Friday, July 3, 2026
Home » Topics » U.S., Medical technology

U.S., Medical technology
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Antibodies fighting coronavirus

Advamed’s Van Meter says COVID-19 antigen testing ramp-up on the short horizon

April 22, 2020
By Mark McCarty
The role of diagnostic and surveillance testing in the COVID-19 pandemic is unquestionably critical, but the volume and type of tests needed to bring the economy back online is complex. Susan Van Meter, director of Advamed Dx, said on an April 22 press briefing that while molecular and serological tests will continue to play a vital role, “we’re going to see millions of antigen tests available in the coming weeks,” a development that will prove crucial in efforts to restore normal economic activity.
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U.S. FDA headquarters

FDA gives Labcorp the nod for Pixel home collection swab, but access limited for now

April 21, 2020
By Mark McCarty
The U.S. FDA reported that it has expanded the emergency use authorization for the Labcorp polymerase chain reaction (PCR) test for SARS-CoV-2 to include the company’s Pixel self-collection kit, a development that may presage a wider testing paradigm that is needed to restore the U.S. economy to normalcy.
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Coronavirus vs U.S. wrecking balls

Administration’s outpatient-first policy should aid cardiovascular, orthopedic implants

April 21, 2020
By Mark McCarty
The Trump administration has proposed a policy to gradually reopen the U.S. for business, part of which is to allow a resumption of elective procedures and treatments in outpatient settings. While patients with urgent medical needs presumably are being treated already, the policy would seem to promise a boost in volumes for certain devices, such as coronary artery stents, knee implants and transcatheter aortic valve replacement (TAVR) devices, all of which enjoy at least limited Medicare coverage for outpatient use.
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Patent law book and gavel

Federal Circuit overturns, remands district court decision in Cardionet infringement case

April 20, 2020
By Mark McCarty
In a decision that seems to have yet again roiled the patent subject matter eligibility question, the U.S. Court of Appeals for the Federal Circuit determined that a district court had erred in determining the 7,941,207 patent held by Cardionet LLC, of Conshohocken, Pa., is not eligible for patent protection.
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Keith Ligon, chief of neuropathology, Brigham and Women's Hospital

For gliomas, hypermutated does not mean sensitive to checkpoint blockade

April 17, 2020
By Anette Breindl
The largest study to date on hypermutated gliomas has delivered new insights into their origin, as well as their response to several different treatments. Specifically, even though they are hypermutated, such tumors are unlikely to respond to PD-1 blockers.
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4-17-intuitive-da-vinci.png

Intuitive climbs on earnings, but cautious on growth in procedures, hospital sales

April 17, 2020
By Stacy Lawrence
Robotic-assisted surgical procedures have fallen off steeply as the ongoing global pandemic has unfolded, but the real impact on Intuitive Surgical Inc. will come as its hospital customers may have to limit orders for expensive equipment upgrades as they struggle to manage unprecedented financial burdens. The U.S. accounts for about 70% of its robotic surgery procedures, but by the last few weeks in March, that activity had been curtailed by roughly two-thirds.
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Digital illustration of U.S., coronavirus

Policymakers seek big data’s help with COVID-19, but mobile device collection raises concerns

April 16, 2020
By Mark McCarty
A recent Senate hearing raised the question of whether privacy and confidentiality are at risk when software is installed in smart devices for disease surveillance purposes, but there may be no absolute guarantee of confidentiality, jeopardizing the goodwill of citizens who are wary of big government.
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Abbott-ID-now.png

Abbott beats revised expectations for quarter, sees launch of COVID-19 tests

April 16, 2020
By Liz Hollis
Despite challenges associated with the ongoing COVID-19 pandemic, Abbott Laboratories saw its first-quarter revenue beating expectations, coming in at $7.73 billion vs. an expected $7.44 billion. Cowen’s Josh Jennings highlighted this result, adding in a note that while there are challenges for nondiabetes medical devices and core diagnostics, areas including diabetes, nutrition, the established pharmaceuticals division and COVID-19 testing shined.
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U.S. Securities and Exchange Commission

SEC clamping down on companies’ COVID-19 claims

April 16, 2020
By Mari Serebrov
Public drug and device companies may want to think twice before eagerly jumping on the COVID-19 bandwagon with announcements overselling their efforts to develop or repurpose products to treat patients infected with the coronavirus.
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WHO headquarters, Geneva

EU leaders pan Trump’s move to halt U.S. funding as WHO updates COVID-19 response plan

April 15, 2020
By Nuala Moran
LONDON - The director general of the World Health Organization has given a dignified and measured response to President Donald Trump’s decision to halt U.S. funding of WHO, pending a review of its handling of the coronavirus pandemic.
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