Fitbit, NASA get latest FDA emergency authorizations for ventilators

The Latest

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  Tracking the impact of coronavirus on the medtech industry

  Among the latest: Quest Diagnostics updated investors Wednesday it's continued to experience a "material decline" in testing volumes since reporting Q1 results, but it's also recovered faster than anticipated in certain regions.

  UPDATED: June 3, 2020 at 11:15 a.m.

  Medical Devices

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  Tests to detect cancer, guide treatment heat up with barrage of data at ASCO

  Exact Sciences, Guardant Health and Oncocyte were among the companies to share data on products targeting breast and lung cancers.

  Diagnostics

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  At-home COVID-19 test kits set to climb as Quest, LetsGetChecked get FDA nods

  Direct-to-consumer startup LetsGetChecked currently has capacity for 300,000 of the self-collection products per week. Quest hasn't yet launched its offering but said more than 500,000 of its sampling kits will be available by end of June.

  Diagnostics

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  Four deaths trigger Class I recall for parts of Medtronic's HeartWare system

  The FDA issued the safety alert Thursday, its second in quick succession. The ventricular assist device has been the subject of more than a dozen such high-risk recall notices since 2014.

  Medical Devices

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  Deep Dive

  How tariffs ravaged the COVID-19 medical supply chain

  Months into the pandemic, the U.S. faces an ongoing shortage of PPE, with some of those products still subject to tariffs.

  Manufacturing

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  Widespread shortages for COVID-19 test materials persist, poll says

  The survey by the Association for Molecular Pathology also found Abbott and Roche make the first-choice assays in 16% and 17% of centers, respectively — the most popular after in-house diagnostics with EUAs.

  Diagnostics

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  FDA offers reference panel to validate coronavirus tests amid false negatives

  The aim is to aid commercial and lab developers in ensuring diagnostic testing quality with independent performance validation. Recent studies flagged double-digit rates of false negatives among such tests.

  Policy & Regulation

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  Spine, cancer doc leaders among top recipients of device, drug industry funds, analysis finds

  Officials at 10 influential medical associations in the U.S. have extensive financial ties to industry, according to a study published in BMJ.

  Medical Devices

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  Emergency authorization granted to COVID-19 ICU prediction software

  The FDA nod for CLEW Medical's system is among a series of regulatory OKs for products designed to inform care for infected patients.

  Medical Devices

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  Health systems, ASCs see restart of elective care taking months despite steps to ease patient fears

  The biggest worry among providers is the possibility of an outbreak or second wave, followed by low patient demand and inadequate supplies, according to a new survey from consulting firm Deloitte.

  Medical Devices

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  EU group sets path for pre-MDR notified body renewal, coronavirus-era surveillance

  A new guidance applies to designating authorities and medical device sector notified bodies whose designations would have expired between this week and the Medical Device Regulation's delayed go-live date next May.

  Medical Devices

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  Fujifilm announces delay to $1.63B buyout of Hitachi's diagnostic imaging arm

  Citing COVID-19's impacts as a source of slowdown, Fujifilm said the deal is no longer expected to close in July.

  UPDATED: May 28, 2020 at 9:03 a.m.

  M&A

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  CDC seeks to limit false positives with COVID-19 antibody testing, as immunity question lingers

  The interim guidelines promote using high-specificity assays and conducting confirmatory tests when appropriate. However, the agency won't yet use serologic test results to sway public health recommendations.

  Policy & Regulation

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  FDA Breakthrough Devices Program nears 300 designations

  The agency has tapped 50 devices so far this year, with recent nods to Orteq, Thermedical, ArcherDX, Helius, PhotoPharmics and Terumo.

  Medical Devices

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  Analysts saw 30% drop in TAVR growth in April, but Q2 may be better than feared

  The Jefferies tracker suggests volume expectations for players in the transcatheter aortic valve replacement market, such as Edwards Lifesciences and Medtronic, may prove a bit conservative.

  Medical Devices

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  Medtechs eye key role of ASCs in return of elective care

  Elective procedures were increasingly moving from hospitals to lower-cost ambulatory surgery centers prior to COVID-19. Now, ASCs may have a new advantage as a setting where patients feel safer returning to care.

  Medical Devices

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  ResMed, Medtronic embrace remote tech amid COVID-19, say it's here to stay

  The crisis has sped adoption of digital health technologies to help hospitals create safe physical distances between healthcare workers and patients. Execs say some could become permanent products.

  Medical Devices

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  Inari Medical launches IPO, shares take off

  The maker of mechanical thrombectomy devices sees a $3.6 billion annual U.S. market opportunity. It had the best first-day performance of 74 initial public offerings launched so far this year, Bloomberg calculated.

  Medical Devices

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  Martha plots M&A, Hugo robot sees delay: Takeaways from Medtronic's Q4

  Despite the negative impacts of COVID-19 on revenue in the latest quarter, the medtech giant has its strongest balance sheet in years and is looking for acquisition opportunities in the pandemic landscape.

  Medical Devices

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  Abbott, Roche ink deals with UK for 10M coronavirus antibody tests

  The notice from the government, which bought $20 million in unreliable antibody tests early in the crisis, came as FDA removed 28 products from a list of the tests that can be used without emergency use authorizations.

  Policy & Regulation

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  FDA eases rules on changes to PMA, HDE devices to avoid coronavirus supply disruptions

  Companies that market medical devices under premarket approvals or humanitarian device exemptions can make limited modifications to design and production without giving prior notice, according to special guidance.

  Medical Devices

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  Medtronic's revenue dropped 26% in Q4 as coronavirus hit broadly

  New CEO Geoff Martha told investors Thursday nearly all sides of the business were negatively impacted by the pandemic's effects. 

  Medical Devices

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  Hospitals push FEMA to form broad supply pact with medtech

  The agency on Thursday is set to discuss a proposed five-year voluntary agreement with industry to better distribute medical products, which health systems hope will go beyond personal protective equipment.

  UPDATED: May 26, 2020 at 7:20 a.m.

  Medical Devices

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  April was dismal for US hospitals, with long road ahead, surveys find

  Operating margins plummeted 174% last month compared to April 2019 and were down 118% from March of this year as surgeries, ER visits and outpatient appointments declined drastically during the COVID-19 pandemic.

  Medical Devices

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  AdvaMed, health systems set ground rules for return of sales reps

  Hospitals, nurses and the medtech industry issued guidance to pave the way for device company representatives to re-enter healthcare facilities.

  Medical Devices

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