Abbott Archives - Page 33 of 34 - Medical Design Sourcing

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…

MedTech 100 roundup: Markets skid after strong stretch

Following a strong performance over the last couple of weeks, the medtech market experienced one of its most significant drop-offs in recent months amid investor worries over a rise in COVID-19 cases in some states.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 82.12 points at the end of last week (June 12). That total represents a -6% decrease from the 87.37-point total at the same time a week prior (June 5), highlighting a significant drop from one of the strongest stretches the medtech market had seen since the COVID-19 pandemic hit.

Meanwhile, the S&P 500 Index experienced a -4.8% decrease from June 5 to June 12, and the Dow Jones Index fared even worse with a -5.6% increase over the same period of time. The drop-off is stark compared to this time a week ago, when both indexes saw sizeable growth — rising 3.14% and 6.81%, respectively.

The earlier market surge came on the back of t…

Abbott declares 386th consecutive quarterly dividend

Abbott (NYSE:ABT) announced today that it has declared a quarterly common dividend of 36¢ per share.

The Abbott Park, Ill.-based company said in a news release that the declaration marks the 386th consecutive quarterly dividend paid by the company since 1924. The dividend is payable on Aug. 17, 2020, to shareholders of record at the close of business on July 15, 2020.

Abbott said it has increased its dividend payout for 48 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, tracking companies that have increased dividends every year for at least 25 consecutive years.

Shares of ABT were up 0.8% at $88.44 per share in mid-afternoon trading today.

Surmodics wins CE Mark for drug-coated balloon

Surmodics (NSDQ:SRDX) announced today that it received CE Mark approval in Europe for its SurVeil drug-coated balloon (DCB).

SurVeil is a next-generation DCB designed for treating peripheral artery disease (PAD) with a proprietary drug-excipient formulation for a durable balloon coating. Pre-clinical data shows a more evenly distributed and durable drug effect and lower incidence of downstream drug particles compared to control DCBs, according to a news release.

In February 2018, Abbott (NYSE:ABT) paid $25 million up front for the global commercialization rights to the SurVeil device. The deal put another $67 million in milestones on the table, the first of which was triggered when Surmodics closed enrollment for its Transcend pivotal trial in August 2019.

Obtaining CE Mark approval clinches another milestone payment in the agreement, as Surmodics is now set to receive $10.8 million. The company said it will recognize approximately $6.5 million as revenu…

MedTech 100 roundup: Stocks stand pat in June’s first week

While the markets experienced some growth over the past week, stocks in the medtech industry remained practically unchanged over seven days.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 87.15 points at the end of last week (June 5). That total represents just a -0.02-point decrease from the 87.17-point total at the same time a week prior (May 29), which represented the industry’s highest point since before the COVID-19 pandemic took hold of the markets.

Meanwhile, the S&P 500 Index experienced a 3.14% increase from May 29 to June 5 and the Dow Jones Index fared even better with a 6.81% increase over the same period of time. The market surge came on the back of the White House announcement that 2.5 million jobs were added in May and unemployment rose to 13.3% when a surge to nearly 20% was expected, according to Yahoo Finance.

The lowest point for medtech during the COVID-19 pand…

Abbott shares take hit after Goldman Sachs lowers rating

Abbott (NYSE:ABT) shares took a hit this week after Goldman Sachs reduced its rating on the stock to sell, from neutral.

The dip also comes on the back of an urgent field safety notice warning on issues with the TactiCath quartz contact force ablation catheter.

According to The Street, Goldman Sachs advised investors on June 1 to sell Abbott stock, claiming it “lost its early lead in coronavirus tests to competitors.” The report also mentioned that while the company has delivered on heightened expectations for testing, there had been concern over testing accuracy.

The safety notice, dated on May 28 and issued in Germany, warns of complaints regarding a loss of contact force information while using the TactiCath product. This issue could cause ineffective ablation that could lead to atrial fibrillation (AF) recurrence or need for the procedure to be repeated.

On May 29, a day after the notice was issued, Abbott shares were trading at $9…

Abbott issues urgent field safety notice over ablation catheter

Abbott (NYSE:ABT) has issued an urgent field safety notice to notify users of complaints about the TactiCath quartz contact force ablation catheter.

The notice out of Germany, dated May 28, warns on complaints regarding a loss of contact force information while using the TactiCath product. This issue could cause ineffective ablation that could lead to atrial fibrillation (AF) recurrence or need for the procedure to be repeated.

Other risks include those associated with the insertion of a replacement catheter or catheter exchanges, the potential for cardiac perforation and associated harms and clinically significant or minor delays in the procedure.

Abbott said in the notice that, over a 26-month period, more than 3,600 of 84,104 (4.3%) catheters distributed had loss of contact force information reported.

In total, there were 2,985 cases in which a single catheter was exchanged due to the issue and 381 cases in which three, four or five catheters w…

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.

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