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Drug-Device Combinations

Surmodics’ DCB shown non-inferior to Medtronic’s In.Pact Admiral

January 26, 2021 By Sean Whooley Leave a Comment

Surmodics (NSDQ:SRDX) announced data showing that its SurVeil drug-coated balloon is non-inferior to Medtronic’s In.Pact Admiral. Eden Prairie, Minn.-based Surmodics’ 12-month data from the Transcend clinical trial, presented at the Leipzig Interventional Course 2021 virtual event, revealed primary results that found the SurVeil DCB is non-inferior to In.Pact Admiral in both safety and efficacy while delivering […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Vascular Tagged With: Medtronic, SurModics Inc.

How continuous glucose monitors have transformed the diabetes landscape

January 25, 2021 By Brian Buntz Leave a Comment

Continuous glucose monitors (CGMs) are among the most potent diabetes management tools to emerge in recent decades. FDA approved the first professional CGM in 1999, and the technology has evolved swiftly since then. Current models beam data via Bluetooth to smartphones (plus the Apple Watch) and the cloud, enabling patients to explore their blood glucose […]

Filed Under: Blog, Diabetes, Digital Health, Drug Pumps, Drug-Device Combinations, Featured Tagged With: A1C, blood glucose, blood glucose monitoring, CDC, CGM, continuous glucose monitor, diabetes, fingerstick, hypoglycemia, smartphone

Johnson & Johnson vaccine trial results expected soon

January 22, 2021 By Sean Whooley Leave a Comment

Trial results for the COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) are reportedly expected to be released soon. The Hill reported last week that former FDA Commissioner Scott Gottlieb said the single-dose vaccine from J&J appears to have a “good profile for a vaccine,” indicating the potential for a third authorized candidate, following those […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceutical Tagged With: coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, Johnson & Johnson

Biden’s COVID-19 response will make manufacturers busy

January 21, 2021 By Nancy Crotti Leave a Comment

Manufacturers of vaccine supplies and personal protective equipment can expect more work as the new Biden administration rolls out its plans to combat the COVID-19 pandemic. In one of his first official acts as president, Joe Biden announced a plan to “fully use” the Defense Production Act to ramp up production of testing supplies, masks, […]

Filed Under: Business/Financial News, Diagnostics, Distribution, Drug-Device Combinations, Featured, Medical Device Manufacturers Assn. (MDMA) Tagged With: 3m, AdvaMed, BD, becton dickinson, International Safety Equipment Association, Medical Device Manufacturers Association, Medline Industries Inc., PPE

Mylan must face EpiPen racketeering lawsuit

January 21, 2021 By Nancy Crotti Leave a Comment

A federal judge in Minnesota has decided that Mylan must face a lawsuit accusing it of paying bribes and kickbacks to pharmacy benefit managers and of conspiring to fix prices on its EpiPen device. Drug wholesalers Rochester Drug CoOperative and Dakota Drug filed separate but similar lawsuits in March 2020 and June 2020, respectively, claiming that Mylan […]

Filed Under: Drug-Device Combinations, Featured, Legal News Tagged With: Mylan

EmblemHealth to provide coverage for Senseonics’ Eversense CGM

January 20, 2021 By Sean Whooley Leave a Comment

Senseonics (NYSE:SENS) announced that EmblemHealth is now providing coverage for its Eversense continuous glucose monitoring system. Germantown, Md.-based Senseonics said in a news release that the immediately effective decision adds to the number of payers writing the Eversense system into their CGM coverage policies and paying for the healthcare provider’s time for the in-office sensor placement. […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Patient Monitoring Tagged With: Senseonics

Senseonics announces $50M from stock offering

January 19, 2021 By Sean Whooley Leave a Comment

Senseonics (NYSE:SENS) announced that it entered into securities purchase agreements worth gross proceeds of approximately $50 million. Germantown, Md.-based Senseonics’ purchase agreements are with several healthcare-focused investors, as well as other institutional investors, according to a news release. Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Funding Roundup, Patient Monitoring Tagged With: Senseonics

These medtech stocks performed the best in 2020

January 15, 2021 By Sean Whooley Leave a Comment

While 2020 did not go as planned for anyone, with the twists and turns came opportunities for medtech companies to power forward. Innovations came both as a result of the COVID-19 pandemic and perhaps in spite of the challenges brought on by the virus, highlighted by the increased efforts to produce vaccines and testing while […]

Filed Under: 510(k), Big Data, Business/Financial News, Cardiac Implants, Cardiovascular, Diabetes, Diagnostics, Drug-Device Combinations, Electronic Medical Records (EMR), Featured, Food & Drug Administration (FDA), Funding Roundup, Genomics/Molecular Diagnostics, Health Technology, MassDevice Earnings Roundup, Mergers & Acquisitions, Orthopedics, Regulatory/Compliance, Replacement Heart Valves, Research & Development, Respiratory, Robotics, Software / IT, Structural Heart, Surgical, Wall Street Beat Tagged With: Abbott, Abiomed, coronavirus, COVID-19, Dexcom, Edwards Lifesciences, Hologic, Intuitive Surgical, iRhythm Technologies Inc., Masimo, ResMed, ResMed Inc., Stryker

MedTech 100 roundup: Industry peaks again after new vaccine authorization

December 21, 2020 By Sean Whooley

Recent news in the industry continues to drive its stocks forward, with COVID-19 vaccine developments driving further medtech growth last week. The FDA granted Moderna emergency use authorization for its vaccine candidate on Friday and its rollout to the U.S. is beginning today. Moderna’s vaccine joins the one made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), which […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Mergers & Acquisitions, Pharmaceutical, Research & Development, Wall Street Beat Tagged With: AstraZeneca plc, becton dickinson, Boston Scientific, coronavirus, COVID-19, COVID-19 vaccine, Federal Trade Commission (FTC), Johnson and Johnson, MedTech 100 Index, Philips, Stryker, Wright Medical

BREAKING: BD orders for COVID-19 vaccine injection devices surpass 1 billion

December 16, 2020 By Chris Newmarker

Becton Dickinson (NYSE:BDX) announced today that orders have surpassed 1 billion for syringes and needles needed to deliver COVID-19 vaccines. The Franklin Lakes, N.J.–based medtech giant now has commitments from governments in countries including the United States, Australia, Belgium, Canada, Germany, Netherlands, Saudi Arabia, Spain and the United Kingdom. Get the full story on our sister […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured Tagged With: BD, coronavirus, COVID-19, syringes

BD is playing a crucial role delivering COVID-19 vaccines: Here’s how

December 15, 2020 By Chris Newmarker

Hundreds of millions of vaccine doses will require hundreds of millions of syringes from companies such as BD. As much-hoped-for COVID-19 vaccines roll out to the public, Becton Dickinson (NYSE:BDX) faces an arguably impressive challenge: The Franklin Lakes, N.J.–based medtech giant already has commitments to provide more than 800 million needles and syringes to deliver future COVID-19 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured Tagged With: BD, becton dickinson, coronavirus, COVID-19, syringes

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