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Nancy Crotti

Study: Medtronic’s drug-coated balloon reduces dialysis interruptions

August 26, 2020 By Nancy Crotti

Medtronic (NYSE:MDT) recently announced the results of a study showing that some kidney disease patients who had a drug-coated balloon (DCB) implanted to treat arteriovenous (AV) failure experienced fewer interruptions of dialysis treatment. Many end-stage renal disease (ESRD) patients require AV fistulae in order to receive continuous dialysis. Blood vessels that feed the access site can […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured Tagged With: Medtronic, New England Journal of Medicine

Report: Will Dr. Hahn crack under political pressure?

August 10, 2020 By Nancy Crotti

Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of defending science while working for the Trump administration. Hahn has been squeezed between expressing his professional […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: Centers for Disease Control & Prevention, coronavirus, COVID-19, Donald Trump, FDA, U.S. Department of Health & Human Services

Tandem Diabetes posts $27m Q2 loss, reinstates earlier guidance

July 30, 2020 By Nancy Crotti

Tandem Diabetes Care

Tandem Diabetes Care (NSDQ:TNDM) posted Street-beating second-quarter sales and missed badly on earnings, but reinstated its earlier full-year 2020 guidance. The San Diego-based company — maker of insulin pumps and other diabetes management devices — reported a loss of -$27.1 million or -0.45¢ per share, on sales of $109.2 million for the three months ended June […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Wall Street Beat Tagged With: Tandem Diabetes Care

Smiths Medical lands major vaccine-related contract

July 15, 2020 By Nancy Crotti

Smiths Medical announced today that it has landed a federal contract to produce more than 78 million syringe-and-needle units and $20 million in federal funding to expand its Keene, N.H. plant to produce them. The Plymouth, Minn.-based company said it received an order for 78.6 million syringe-and-needle units and that BARDA and the Joint Program […]

Filed Under: Business/Financial News, Contract Services, Featured, Funding Roundup Tagged With: BARDA, coronavirus, COVID-19

Teva launches connected inhaler for asthma, COPD

July 13, 2020 By Nancy Crotti

Teva Pharmaceutical logo - updated

Teva (NYSE:TEVA) announced today that it has launched a Bluetooth-enabled version of its ProAir albuterol sulfate rescue inhaler. The ProAir Digihaler’s sensors connect to a companion mobile app to provide inhaler-use information to healthcare providers. The new inhaler is available by prescription to U.S. patients age 4 and older, according to the Tel Aviv, Israel-based company. […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: Teva Pharmaceuticals

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

June 29, 2020 By Nancy Crotti

Abbott logo updated

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 […]

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Featured, Uncategorized, Wall Street Beat Tagged With: abbott, Tandem Diabetes Care

Pandemic forces Proteus into bankruptcy

June 16, 2020 By Nancy Crotti

Proteus Digital Health updated logo

Proteus Digital Health has filed for Chapter 11 bankruptcy protection, noting that its efforts to raise money or sell the company fell victim to the COVID-19 pandemic. The Redwood City, Calif.-based company missed a $100 million funding target in December. Once valued at $1.5 billion, Proteus previously raised $420 million from investors including Novartis Venture Fund […]

Filed Under: Business/Financial News, Cardiovascular, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: Otsuka Pharmaceutical, Proteus Digital Health, Robert Bosch North America, Romaco North America, Xcelience

Medtech manufacturers must add warning label to drug-eluting PAD devices

June 16, 2020 By Nancy Crotti

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Regulatory/Compliance, Vascular Tagged With: B. Braun Medical, Biosensors International, Biotronik, Boston Scientific, cook medical, FDA, Lutonix, LVD Biotech, Medtronic, Spectranetics, UK Medicines and Healthcare products Regulatory Agency

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

June 15, 2020 By Nancy Crotti

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 […]

Filed Under: Auto-injectors, Big Data, Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Research & Development Tagged With: abbott, American Diabetes Association, Centers for Medicare and Medicaid Services (CMS), dariohealth, Medtronic, One Drop, Tandem Diabetes Care

Medtronic touts results of latest MiniMed studies at ADA

June 12, 2020 By Nancy Crotti

Medtronic logo updated

The latest generation of the Medtronic (NYSE:MDT) MiniMed insulin pump met both safety and glycemic endpoints in a study presented today at the American Diabetes Association’s virtual annual conference. The MiniMed 780G closed-loop system is indicated for treating Type 1 diabetes in people aged 7 to 80 years old. It is designed to automate the delivery of […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured Tagged With: American Diabetes Association, Medtronic

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