Abbott device growth returns as Wall Street queries staying power of COVID-19 test boom

The Latest

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  Future of COVID-19 products, device shortages, CDS top CDRH 2021 to-do list

  Regulators aim to publish final guidance on five topics and draft documents on another dozen priority areas in the coming year. A few of the goals are carryovers as priorities shifted during the public health emergency.

  Medical Devices

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  Philips Q3 connected care sales up 42%, but ventilators to decline next year

  The company expects the COVID-19 tailwinds, including double-digit growth in patient monitors and ventilators, to extend through the fourth quarter but fall away in 2021.

  Medical Devices

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  FDA, medtechs envision new era for clinical trials amid COVID-19 shake-up

  Medtronic, for example, has faced "very significant delays" in getting products approved as a result of research disruptions, the company's VP of global clinical affairs said during a discussion at TCT.

  UPDATED: Oct. 20, 2020 at 2:50 p.m.

  Medical Devices

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  Boston Scientific faces TAVR setback vs. Medtronic, 3-year delay to US launch of redesigned valve

  The medtech's stock fell 4% on news that its Acurate neo valve did not achieve noninferiority against Medtronic's CoreValve Evolut, and subsequently that the FDA needs more data for a product submission to be successful.

  Medical Devices

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  CMS to cut COVID-19 test pay by 25% for delayed results, labs cry foul

  The American Clinical Laboratory Association, which includes LabCorp and Quest, argued the new policy fails to address the root of delays: fluctuating demand and supply chain disruptions.

  Policy & Regulation

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  Intuitive sees partial Q3 recovery but warns COVID-strained hospital finances continue

  Between customers tightening their belts and having first-time competition on the horizon, the longtime robotic surgery leader is rethinking approaches to pricing and M&A.

  Medical Devices

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  Stryker reaches agreement with Colfax for Wright Medical deal divestitures

  The medtech disclosed Thursday the orthopaedics competitor's DJO Global subsidiary agreed to acquire its ankle and finger joint replacement businesses to shore up U.S. and U.K. antitrust concerns.

  UPDATED: Oct. 16, 2020 at 11:47 a.m.

  Medical Devices

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  Medtronic CEO pitches strategy revamp, but Wall Street takes wait-and-see approach

  Geoff Martha laid out a new operating model to investors, acknowledging the medtech giant has too often grown "below its markets" and that its market share is "not commensurate with our technology leadership."

  Medical Devices

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  Roche diagnostics Q3 sales spiked 18% as COVID-19 offset routine test drop

  Execs contend the momentum is sustainable even with arrival of a vaccine, citing government demand for high-throughput machinery and a shift in importance to antibody testing.

  Diagnostics

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  CMS expands Medicare emergency telehealth coverage with 11 new services

  For the first time in five months, the agency made new virtual care additions including electronic analysis of an implanted neurostimulator pulse generator and intensive cardiac rehab with or without continuous EKG monitoring.

  Policy & Regulation

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  Medtronic pits TAVR device against Edwards Sapien 3, eyes challenge to Abbott's MitraClip

  The company appears to be doubling down on structural heart competition with a series of investments in the transcatheter aortic valve replacement and mitral valve repair markets.

  Medical Devices

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  FDA finalizes guidance on nitinol devices, posts biocompatibility draft

  The agency has been looking at the alloy, commonly used in stents and heart valves, as part of a broader look at metals that can cause inflammatory or other types of reactions once inside the body.

  Medical Devices

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  J&J-backed Cue gets $481M to onshore production of rapid COVID-19 test kit

  The startup will use the government funding to scale production to 100,000 COVID-19 test kits a day at its San Diego facilities.

  Diagnostics

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  With rivals delayed, Intuitive Surgical extends use of robotic instruments

  The program could help expand the da Vinci robot's place in gallbladder removal and hernia repair, as Medtronic and J&J face pandemic-related delays to launching their systems. 

  Medical Devices

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  J&J US device unit returns to growth, potential bellwether for medtech Q3 earnings

  A double-digit rise in interventional sales was offset by ongoing headwinds in parts of the orthopaedic and surgery franchises.

  Medical Devices

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  Old market, new growth: Medtronic and Axonics competition ups sacral neuromodulation's reach

  In a challenging year for elective procedures, Medtronic estimates a key pelvic health market that's grown in the mid-single digits for the last 25 years increased 20% this past quarter.

  Medical Devices

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  Qiagen beats sales forecast on COVID-19 growth, but leaves room for skeptics

  Non-coronavirus revenue saw a mid-single-digit drop and sales of a key TB test fell 20%. While those metrics improved from earlier in the year, Cowen analysts said the slump gives ammunition to doubters.

  Diagnostics

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  TCT 2020: Abbott devices, TAVR systems headline late breaker lineup

  The five-day Transcatheter Cardiovascular Therapeutics event kicked off Wednesday.

  Medical Devices

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  Elective surgeries seen driving Q3 medtech comeback, but can it last?

  A robust recovery in medical device procedures is forecast for the third quarter as patients rescheduled, but some analysts are now seeing a leveling off in hospital activity. The flu season also poses a risk going into the winter.

  Medical Devices

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  De Novo-winning devices often lack effectiveness data, analysis shows

  A JAMA Internal Medicine analysis of 63 devices reviewed via FDA's premarket pathway for novel technologies found one-fifth weren't evaluated in pivotal studies.

  Medical Devices

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  Cancer testing drives 2020 medtech IPO surge after slow start

  A flurry of activity began in June, including from China-based Burning Rock and Genetron and U.S.-based Progenity.

  Medical Devices

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  5 key exec insights from 2020's MedTech Conference

  Top leaders from Abbott, BD, Medtronic, Stryker and Zimmer Biomet shared the latest on the industry's recovery during the pandemic and thoughts on where it goes from here.

  Medical Devices

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  Roche, Abbott, LDTs are most used COVID-19 tests as supply chain constraints force labs to diversify

  Shortages of test kits and other supplies persist, according to the labs polled by the Association for Molecular Pathology.

  Diagnostics

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  FDA takes hands off EUA review for COVID-19 lab developed tests

  The move follows the administration in August no longer requiring premarket review for LDTs, letting labs voluntarily seek emergency use nods. A lab trade group said the latest decision creates "unnecessary confusion."

  Policy & Regulation

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  Fresenius sees COVID-19 driving dialysis device growth, eyes home care strategy

  Execs at the company, which upped production of machines by 230% in response to the crisis, laid out plans at an investor day Thursday.

  Medical Devices

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