Abbott Archives - Page 34 of 34 - Medical Design Sourcing

Bigfoot Biomedical raises $55m in Series C

Diabetes treatment tech company Bigfoot Biomedical announced today that it raised $55 million to close its Series C financing round.

Abbott (NYSE:ABT) led the funding round with participation from new investor Smile Group and existing investors Quadrant Capital Advisors, Senvest Capital, Janus Henderson and Cormorant Asset Management.

Milpitas, Calif.-based Bigfoot said in a news release that the proceeds will support product development and the regulatory pathway for its Bigfoot Unity system as a part of the Bigfoot Unity Diabetes Management Program.

The program is a real-time, dose-decision support system for people with insulin-requiring diabetes that rely on multiple daily injection therapy, which is the most common therapy for people with Type 1 and Type 2 diabetes. The Unity system features smart pen caps for basal and meal-time insulin dosing recommendations through integration with Abbott’s FreeStyle Libre system.

Plans for Bigfoot U…

FDA adds reference panel to study COVID-19 diagnostics

The FDA has released a new reference panel to evaluate diagnostic tests for COVID-19.

Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration and monitoring of assay performance, according to the agency.

Nucleic acid tests identify infection by confirming the presence of a virus’ genetic material (RNA), and the FDA said its new reference panel provides developers access to this material.

The agency described it as an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes. It is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process.

“The FDA has taken many steps during this pandemic to ensure that Americans have access to trustworthy diagnostic tests,” said Jeffrey Shuren, director of the FDA’s Center for Devi…

15 heart devices that could boost their manufacturers’ sales

(Image from Cardiovalve)

Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices.

Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures.

Now hospitals are looking at ways to safely return to business-as-usual — they and the medical device industry as a whole hope to improve their balance sheets. For example, Medtronic (NYSE:MDT) CEO Geoff Martha and CFO Karen Parkhill expressed optimism in an analyst call today that their company’s businesses already are showing signs of a rebound in the month of May.

Get the full story on our sister site, Medical Design & Outsourcing.

Abbott: ID NOW COVID-19 results more accurate with earlier testing

Abbott’s ID Now test machine (Image from Abbott)

Abbott (NYSE:ABT) said today that its ID NOW COVID-19 test works better on specimens collected soon after patients begin showing symptoms.

The test’s performance has drawn fire from federal officials in recent weeks, including a recent FDA warning that the ID NOW test may return false-negative results. The agency granted the test an emergency use authorization (EUA) on March 27 and said it is now investigating whether false-negative results could be due to the types of swabs used or the type of viral transport media.

Abbott began advising customers in mid-April that ID NOW is a rapid test that was not designed for use with viral transport media. The company also recommended using dry nasal swabs to collect samples.

Today, the company announced an interim analysis of an ongoing clinical study at five urgent care clinics in New Jerse…

Abbott to supply millions of its COVID-19 antibody tests to U.K. government

Abbott (NYSE:ABT) will supply millions of its laboratory-based COVID-19 antibody tests to the U.K.’s National Health Service over the coming months under a contract announced today.

The company has already shipped 800,000 of the IgG antibody test to NHS laboratories this week. The news comes on the same day that Abbott said that Health Canada has granted interim authorization for the IgG serology test, which last month received an FDA emergency use authorization in the U.S. and CE Mark in the EU.

The IgG test runs on Abbott’s Architect i1000SR and i2000SR and Alinity i laboratory instruments. Widely used in laboratories around the world, the Architect system is able to run 100–200 tests per hour.

“Abbott is proud to support the NHS’ COVID-19 antibody testing strategy announced today, with agreement to supply antibody tests to NHS laboratories across the U.K.,” said Mike Clayton, Abbott’s managing director of Northern …

Health Canada authorizes Abbott COVID-19 antibody test

Abbott (NYSE:ABT) announced today that Health Canada has granted interim authorization for its Architect SARS-CoV-2 IgG serology test for COVID-19.

The Abbott Park, Ill.-based company won an FDA emergency use authorization and the CE Mark for the same antibody test for use on its Architect system in April. The test is designed to detect the IgG antibody, a protein that the body produces in the late stages of infection and may remain up to months after a person has recovered from the novel coronavirus.

A recent study published in the Journal of Clinical Microbiology found that Abbott’s SARS-CoV-2 IgG antibody test had 99.9% specificity and 100% sensitivity for detecting the IgG antibody in patients 17 days or more after symptoms began. Abbott has come under scrutiny for the accuracy of one of its COVID-19 molecular diagnostic tests.

The company said it expects to begin shipping antibody tests to Canada this week and intends to distribute 30 million …

What medtech’s top CEOs are saying about COVID-19

The COVID-19 pandemic is drying up sales for many large medical device companies, but there’s hope for a recovery later this year.

That’s the big message from medtech’s top CEOs as they issue financial predictions and engage in earnings calls with analysts.

Governments around the world are calling on medical device companies to make the supplies that health providers need to manage the virus: respirator masks, ventilators, infusion pumps, virus and antibody tests, and more.

At the same time, the same companies are taking a hit related to the devices and products used in elective procedures — and even procedures that people actually need — as hospitals focus on saving people with COVID-19.

It’s little wonder then that MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — remains down about 10% from its pre-pandemic Feb. 19 high point. (It’s still in better shape than the Dow Jones Industrial Averag…

FDA warns on accuracy of Abbott rapid COVID-19 test

Abbott’s ID Now test machine (Image from Abbott)

After weeks of concerns about the accuracy of an Abbott (NYSE:ABT) rapid COVID-19 diagnostic test, the FDA last night issued a warning that the ID NOW test may return false-negative results.

Citing “early data,” the agency said it is “sharing early information … about potential inaccurate results in the spirit of transparency.”

A preliminary study released this week by researchers at New York University found that the test missed up to 48% of positive results. Researchers at the Cleveland Clinic reported in April that the ID NOW had a false-negative rate of 14.8%, according to a report by National Public Radio.

One issue is the treatment of specimens before they are placed in the ID NOW machine. Abbott advised customers on April 15 that placing specimens in liquid viral transport media before processing — stan…