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COVID-19 diagnostics sales boost Abbott’s Q2 results

Abbott (NYSE:ABT) beat the consensus forecast on Wall Street today — with sales of molecular diagnostics including COVID-19 tests more than tripling.

The Abbott Park, Ill.-based healthcare giant reported profits of $537 million or 57¢ per share, on sales of $7.33 billion for the three months ended June 30, 2020, for a bottom-line plunge of –47% on sales that dropped -8.2.% compared with Q2 2019.

After suspending its year-end forecast in April due to uncertainty related to the pandemic, Abbott projected EPS of $3.25 for the full year 2020, which compares with analysts’ projection of $2.87 per share.

Medical device sales were down more than -21% worldwide to $2.423 billion for the quarter, with diabetes care sales the only category in the black, with a 27.2% increase. Notably, the company received FDA clearance in mid-June for its FreeStyle Libre 2 continuous glucose monitoring system for adults and children ages four and older with diabetes.

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BREAKING: Abbott, Edwards settle heart device patent spats

Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) said this afternoon that they have agreed to settle all outstanding patent disputes related to transcatheter mitral and tricuspid repair products, and Edwards has made an one-time payment of $368 million to Abbott, according to an SEC filing.

The agreement will result in the dismissal of all pending cases or appeals in courts and patent offices worldwide, and includes a provision that the parties will not litigate patent disputes with each other in the field of transcatheter mitral and tricuspid repair and replacement products for the next 10 years. Any injunctions currently in place will be lifted.

A judge in England issued an injunction in April barring Edwards from selling its Pascal transcatheter mitral valve repair (TMVR) device in the U.K. Judge Colin Birss of the High Court of England and Wales also ruled that two patents held by Abbott unit Evalve for its MitraClip TMVR device were valid and that Edwa…

What kinds of COVID-19 tests are out there?

(Image from Mayo Clinic)

Months into the pandemic, the FDA continues to grant emergency use approval (EUA) to new tests to detect the virus that causes COVID-19 and the antibodies that indicate a person has had it.

To date, the FDA has granted EUAs for 171 tests —142 molecular tests, 27 antibody tests, and 2 antigen tests. Given the ever-changing landscape of tests for COVID-19 and the rapid rise of coronavirus cases in the parts of the country, we thought an overview of these tests might be helpful.

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

Abbott wins FDA approval for Bluetooth heart rhythm devices

Abbott (NYSE:ABT) announced today that it received FDA clearance for its next-generation Gallant implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices.

The next-generation devices offer a patient-preferred design with Bluetooth technology and a new patient smartphone app while sidestepping any compromise of battery longevity and MRI compatibility, according to a news release.

Gallant, which received CE Mark approval in February, pairs with Abbott’s myMerlinPulse mobile smartphone app designed to streamline communication between doctors and patients to enhance remote monitoring and enable physicians to identify asymptomatic episodes of cardiac arrhythmias or abnormal heart rhythms, leading to earlier intervention.

In a news release, Mills, N.J.-based Deborah Heart & Lung Center director of electrophysiology and pacing Dr. Raffaele Corbisiero said the capabilities offered by Gallant could…

MedTech 100 roundup: Stocks tick back up to open July

After a solid start to July, the medtech industry continues to experience a stock market roller coaster amid the COVID-19 pandemic.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 84.25 points at the end of last week (July 3). That total represents a 2.9% increase from the 81.88-point total at the same time a week prior (June 26), resulting in another significant direction change, following a -3.7% dip just one week before.

Meanwhile, the S&P 500 Index saw a 4% bump from June 26 to July 2 (market close before a holiday), and the Dow Jones Index fared similarly well, posting a 3.2% increase over the same period of time. Both indexes mirrored the medtech industry’s changes, having each posted decreases the week prior.

Medtech’s lowest point during the COVID-19 pandemic remains at 62.13 on March 23. Since then, the industry’s stocks have experienced 35.6% growth in total. Stocks in the indu…

Abbott, Tandem seal deal to combine CGM, insulin delivery tech

Abbott (NYSE:ABT) and Tandem Diabetes Care (NSDQ:TNDM) announced today that they have completed their agreement to combine the former’s glucose-sensing technology with the latter’s insulin delivery systems.

The deal, announced in October, will combine Abbott’s Freestyle Libre CGM with Tandem’s t:slim X2 pump to monitor glucose without fingersticks. The agreement covers the technical development of device integration and associated commercial support activities.

“We’re excited to integrate our insulin delivery systems with Abbott’s glucose-sensing technology, and we look forward to expanding options for our customers so that they can combine devices that best suit their personal needs,” said Tandem president & CEO John Sheridan in a news release. “We are proud to have an insulin pump capable of remote software updates that can make access to future integrations possible for in-warranty t:slim X2 users at the time of release without requiring a new pump.”

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Abbott, Tandem seal deal to combine CGM, insulin delivery tech

Abbott (NYSE:ABT) and Tandem Diabetes Care (NSDQ:TNDM) announced today that they have completed their agreement to combine the former’s glucose-sensing technology with the latter’s insulin delivery systems.

The deal, announced in October, will combine Abbott’s Freestyle Libre CGM with Tandem’s t:slim X2 pump to monitor glucose without fingersticks. The agreement covers the technical development of device integration and associated commercial support activities.

“We’re excited to integrate our insulin delivery systems with Abbott’s glucose-sensing technology, and we look forward to expanding options for our customers so that they can combine devices that best suit their personal needs,” said Tandem president & CEO John Sheridan in a news release. “We are proud to have an insulin pump capable of remote software updates that can make access to future integrations possible for in-warranty t:slim X2 users at the time of …

Abbott touts new data for its minimally invasive structural heart therapies

Abbott (NYSE:ABT) today announced late-breaking data on some of its structural heart disease products.

The data listed findings on the MitraClip system for transcatheter mitral valve repair, the TriClip system for transcatheter tricuspid valve repair and the Tendyne transcatheter mitral valve implantation system for mitral valve replacement.

Clinical and real-world data showed that transcatheter devices can dramatically change treatment approaches for complex cardiac conditions. The data also showed continuous positive outcomes for less invasive transcatheter therapies, further emphasizing the company’s commitment to advancing new treatment options for mitral regurgitation and tricuspid regurgitation.

MitraClip was shown to have leading safety and effectiveness. With real-world outcomes from four separate analyses, the device showed significant mitral regurgitation and reduction was achieved with the MitraClip NTR/XTR Systems in patients with prima…

Report: FDA lists 106 adverse events for Abbott’s rapid COVID-19 test; none for other rapid tests

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

Users of the Abbott (NYSE:ABT) ID Now point-of-care diagnostic test for COVID-19 have reported 106 false-negative or otherwise incorrect or inadequate results to the FDA since April — and none for other companies’ rapid diagnostics for the novel coronavirus, according to a report by Kaiser Health News.

That’s up from the 15 adverse event reports the agency reported it had received by May 14, when it issued a warning about the test’s accuracy. The FDA granted the ID Now test an emergency use authorization (EUA) on March 27, and by mid-May said it was investigating whether the false-negative results could be due to the types of swabs used or the type of viral transport media. A preliminary study released in May by researchers at New York University found that the test missed up to 48% of positive results. Researchers at the Cleveland Cli…

Abbott, Medtronic go head-to-head at ADA conference

Major medtech companies vied for the biggest news splash at this year’s annual meeting of the American Diabetes Association, announcing promising results from studies of patients who used their latest diabetes technology.

The virtual 80th Annual American Diabetes Association Virtual Scientific Sessions, which runs through Tuesday, so far has featured news out of Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) and several smaller companies as well as studies showing how diabetes tech is helping diverse patient populations. More than 800 sessions have been planned.

Here are some of the highlights of this year’s conference, which began June 12.

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Moody’s lowers its medical device industry earnings forecast

Medical device industry earnings will remain flat over the next 12 to 18 months as people hold off on medical procedures amid the COVID-19 pandemic and resulting recession, according to a new report from Moody’s.

Moody’s had previously projected of 2–4% annual growth.

“While underlying positive trends remain, including ongoing innovation and favorable longterm demographics, we expect some consumers will be slow to return to the healthcare system,” the Moody’s analysts said in the report, out June 11.

“While many procedures are already being rescheduled in certain regions, some consumers will be unable to pay for their procedures due to the economic downturn, as well as their unwillingness to engage with the healthcare system while the coronavirus outbreak persists.”

The predictions from Moody’s come at the same time that medtech industry stocks are taking a hit, along with the overall markets, amid i…

Abbott FreeStyle Libre 2 iCGM FDA cleared for use in adults and children

Abbott (NYSE:ABT) announced today that it received FDA clearance for its FreeStyle Libre 2 system for adults and children ages four and older with diabetes.

The Abbott Park, Ill.-based company touts its FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system as the only such system with optional real-time alarms that measure glucose levels every minute over a 14-day wear time, making it long-lasting and eliminating the need for fingersticks.

FreeStyle Libre 2 uses Bluetooth to automatically alert users when glucose is high or low, removing the need to scan the sensor. Users can also turn off the customizable alarms, should they choose to. The system digitally connects and communicates with other compatible devices to allow for diabetes management to be specifically tailored to a person’s needs.

The sensor for the FreeSytle Libre 2 is worn on the back of the upper arm for 14 days and includes one-second scan capabilities with a hand…