Abbott Archives - Page 28 of 34 - Medical Design Sourcing

Abbott COVID-19 serology test gains EUA

Abbott (NYSE:ABT) this week received FDA emergency use authorization (EUA) for its AdviseDx SARS-CoV-2 IgG II diagnostic.

The serology test from Abbott Park, Ill.-based Abbott is indicated for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 — the virus causing COVID-19 — in human serum and plasma

An FDA letter notifying Abbott of the EUA said the indication includes collections using a serum separator tube for the human serum samples and acid citrate dextrose, sodium citrate, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin in a separator tube, and sodium heparin for the plasma samples.

Abbott’s test is intended for identifying an adaptive immune response to SARS-CoV-2 to indicate recent or prior infection and samples should only be tested from individuals who are 15 days or more post symptom onset. Use of the test is limited to authorized laboratories.

Samples for the test must be analyze…

Abbott researchers help discover a clue to an HIV cure

Scanning electron micrograph of HIV-1 (in green) budding from cultured lymphocyte. [Image courtesy of CDC]Abbott announced today that a team including its scientists has uncovered a rare group of Democratic Republic of Congo residents who are HIV positive but have almost nonexistent viral loads without using antiretroviral treatments.

This group of “HIV elite controllers” opens up a new area for researchers to discover biological trends that could inform the creation of better HIV treatments and potential vaccines.

The researchers from Abbott, Johns Hopkins University, the National Institute of Allergy and Infectious Diseases, the University of Missouri-Kansas City and the Université Protestante au Congo found that the prevalence of HIV elite controllers was 2.7–4.3% in the DRC, versus 0.1–2% worldwide.

Get the full story on our sister site Drug Discovery & Development.

Abbott researchers help discover a clue to an HIV cure

Scanning electron micrograph of HIV-1 (in green) budding from cultured lymphocyte. [Image courtesy of CDC]

Abbott announced today that a team including its scientists has uncovered a rare group of Democratic Republic of Congo residents who are HIV positive but have almost nonexistent viral loads without using antiretroviral treatments.

This group of “HIV elite controllers” opens up a new area for researchers to discover biological trends that could inform the creation of better HIV treatments and potential vaccines.

The researchers from Abbott, Johns Hopkins University, the National Institute of Allergy and Infectious Diseases, the University of Missouri-Kansas City and the Université Protestante au Congo found that the prevalence of HIV elite controllers was 2.7–4.3% in the DRC, versus 0.1–2% worldwide.

The group published their findings today in EBioMedicine (part of The Lancet). Read more

Quidel wins FDA nod for at-home antigen test

The FDA issued an emergency use authorization today for the Quidel Corp. (NSDW:QDEL) QuickVue At-Home COVID-19 test, another antigen test to rapidly collect and test samples at home, without needing to send a sample to a laboratory for analysis.

The QuickVue At-Home COVID-19 test is authorized for prescription home use with self-collected anterior nasal swabs from people ages 14 and older or children ages 8 and older with swabs collected by an adult. The test is authorized for those suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.

“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a news release. “The QuickVue At-Home COVID-19 test is another example of the FDA working with test developers to bring important diagnostics to the public.”

In February…

Looking back at two decades of CGM advances

The Freestyle Libre 2 from Abbott

Continuous glucose monitors (CGMs) have transformed how many people with diabetes manage blood sugar, but attempts to monitor blood glucose have a long history.

Attempts to manage glucose kicked off in earnest when researchers began measuring glucose in urine in the mid-1800s. Scientists’ ability to do so steadily improved over the years, but urine glucose testing wasn’t commercialized until 1908, establishing a foundation for diabetes care.

Elkhart, Ind.-based Ames Company refined the process in 1945 with the introduction of Clinitest reagent tablets, which are still commercially available, albeit from Bayer (ETR:BAYN). The company would introduce the first blood glucose test strip in 1965. The Dextrostix-branded strips were intended for use in doctors’ offices.

Get the full story on our sister site, Drug Delivery Business News.

Looking back at two decades of CGM advances

FreeStyle Libre 2 from Abbott

Continuous glucose monitors (CGMs) have transformed how many people with diabetes manage blood sugar, but attempts to monitor blood glucose have a long history.

Attempts to manage glucose kicked off in earnest when researchers began measuring glucose in urine in the mid-1800s. Scientists’ ability to do so steadily improved over the years, but urine glucose testing wasn’t commercialized until 1908, establishing a foundation for diabetes care.

Elkhart, Ind.-based Ames Company refined the process in 1945 with the introduction of Clinitest reagent tablets, which are still commercially available, albeit from Bayer (ETR: BAYN). The company would introduce the first blood glucose test strip in 1965. The Dextrostix-branded strips were intended for use in doctors’ offices.

In the 1970s, Ames developed a device known as the Ames Reflectance Meter to measure reflected light from a Dextrostix strip. It was the first blood glucose mete…

DTW Podcast: Zimmer Biomet slims, Corza Medical grows in pursuit of grabbing market share

In this week’s DeviceTalks Weekly Podcast, Rich Newitter, managing director at SVB Leerink, says Zimmer Biomet’s decision to spin out its spinal and dental business will accelerate its already impressive market share grab in its core orthopedics industry.

Dewitter says CEO Bryan Hanson brings a tried-and-true diversification model used by companies like his former employer, Covidien. The spinout of the spinal and dental businesses into a NewCo will allows the company to focus more resources on selling knee and hip implants as well as building out an impressive robotics franchise and a potentially sector-leading line of digital tools and sensors.

“Zimmer has effectively gone from a share loser for almost a decade leading up to when Bryan Hanson took over to a share-taking position,” he said in an interview with Chris Newmarker, executive editor of life sciences. “This most recent quarter, their share gains have widened quite dramatically.”

In …

DTW Podcast: Zimmer Biomet slims, Corza Medical grows in pursuit of grabbing market share

In this week’s DeviceTalks Weekly Podcast, Rich Newitter, managing director at SVB Leerink, says Zimmer Biomet’s decision to spin out its spinal and dental business will accelerate its already impressive market share grab in its core orthopedics industry.

Dewitter says CEO Bryan Hanson brings a tried-and-true diversification model used by companies like his former employer, Covidien. The spinout of the spinal and dental businesses into a NewCo will allows the company to focus more resources on selling knee and hip implants as well as building out an impressive robotics franchise and a potentially sector-leading line of digital tools and sensors.

“Zimmer has effectively gone from a share loser for almost a decade leading up to when Bryan Hanson took over to a share-taking position,” he said in an interview with Chris Newmarker, executive editor of life sciences. “This most recent quarter, their share gains have widened quite dramatically.”

In …

MedTech 100 roundup: Index rebounds from dip with another all-time high

The end of January saw the first major dip for the medtech industry but the beginning of February brought yet another peak.

MassDevice‘s MedTech 100 index ended the week (Feb. 5) at 108.23 points, marking a 4% rise from the 104.05-point mark set at the end of the previous week (Jan. 29).

The final mark for the week sets an all-time best for the index, which had previously reached 106.81 points on Jan. 8, then 107.4 points on Jan. 20. The rise has been remarkable, considering the index had never reached even the 100-point mark before November 2020.

Medtech’s latest rise means the index has risen 17.2% from the pre-COVID-19 pandemic high of 92.32, set on Feb. 19, 2020. Additionally, the industry has very much rebounded from its lowest place, a 62.13-point mark at the start of the pandemic on March 23, 2020. Since that point, the industry has jumped 74.2%.

Here are some of the best-performing medtech stocks from 2020.

Medtech’s performanc…

3M, Abbott in top 50 of Fortune’s most admired companies list

[Photo by Guillermo Latorre on Unsplash]Medtech giants 3M (NYSE:MMM) and Abbott (NYSE:ABT) made it into the top 50 of Fortune‘s 2021 World’s Most Admired Companies list.

3M — a manufacturing conglomerate that also has one of the largest medical device businesses in the world — came in at No. 24, up from No. 29 in the 2020 list. Abbott meanwhile was No. 42, up from No. 52.

Both companies have been playing important roles in efforts to manage the COVID-19 pandemic.

3M is an important supplier of N95 masks and other protective gear for healthcare and other essential workers.

Abbott in early 2020 developed three molecular diagnostic tests for the SARS-CoV-2 virus within a 30-day time span. By the late summer, it won an FDA emergency use authorization in the late summer for its speedy BinaxNow COVID-19 Ag Card antigen test.

Other medical device companies making it into the Fortune most admired companies list include Boston Scientific (…

MedTech 100 roundup: January ends with a dip

After spending several weeks on the ascent, medtech stocks leveled out a bit to end January, ending a run of several new highs in 2021.

MassDevice‘s MedTech 100 index ended the week (Jan. 29) at 104.05 points, marking a -2.2% drop from the 106.4-point mark set at the end of the previous week (Jan. 22).

The index had previously reached 107.4 points on Jan. 20, topping the all-time best of 106.81 points set on Jan. 8. That mark represents a 16% jump from the pre-pandemic high of 92.32 set on Feb. 19, 2020, and a 72.9% overall leap from the lowest point of 62.13 set on March 23, 2020.

However, the drop from that high point to medtech’s current position is approximately -3.1%, although the industry still remains well above its pre-pandemic high (12.7%) and its mid-pandemic low point (67.5%).

Here are some of the best-performing medtech stocks from 2020.

While medtech saw a slight decline from the previous week, both of the overall markets fared …

Diagnostics sales boost Abbott in Street-beating Q4

Abbott (NYSE:ABT) shares ticked up this morning on fourth-quarter results that bested the consensus forecast.

The Abbott Park, Ill.-based company posted profits of $2.2 billion, or $1.20 per share, on sales of $10.7 billion for the three months ended Dec. 31, 2020, for a more than doubled bottom line on sales growth of 28.7%.

Adjusted to exclude one-time items, earnings per share were $1.45, 10¢ ahead of Wall Street, where analysts were looking for sales of $9.94 billion.

Three of Abbott’s four major businesses (nutrition, diagnostics and medical devices) saw growth in the quarter, while the company’s established pharmaceuticals arm dipped by -2.3%.

Diagnostics, in particular, saw a large leap year-over-year, with COVID-19 testing boosting the segment to more than $4.3 billion in sales, marking 111.1% growth from 2019. The medical devices segment fared well, bringing in $3.3 billion for 1.7% growth, although U.S. sales dipped by -2.5%.…