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