4 takeaways from Medtronic's latest earnings report

The Latest

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  Latest breakthrough device designations go to brain-computer interface, exo-suit

  Regulatory privileges were awarded to Blackrock Neurotech's brain-computer interface, designed to assist immobile patients with performing activities, and ReWalk Robotics' exo-suit, which is intended to help stroke patients walk. 

  Medical Devices

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  FDA shakes up hepatitis C testing market by opening up 510(k) pathway

  Lowering the barrier to the market could increase competition in spaces targeted by companies such as Abbott Laboratories and Roche. 

  Policy & Regulation

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  CMS proposes smokers begin lung cancer screening at age 50 instead of 55

  The agency is revisiting its national coverage determination to catch the disease at an earlier stage. Needham analysts say a larger pool of patients will drive demand for test makers Veracyte, Oncocyte and NeoGenomics.

  Policy & Regulation

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  Stryker dismisses robotics threat from J&J, Zimmer with bullish forecast

  CEO Kevin Lobo said during Thursday's analyst day that the company is "poised and ready to pounce" if valuations fall as Stryker looks to leverage M&A in long-term growth plans.

  Medical Devices

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  Medtronic leadless pacemaker flagged by FDA for safety risks

  The agency said in a letter to healthcare providers that cardiac perforations associated with Medtronic's Micra device are more likely than traditional pacemakers to be associated with serious complications, such as death.

  Medical Devices

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  Q&A

  New iRhythm CEO talks Medicare pricing, larger medtech competitors, international markets

  "I think the near-term noise is something that we'll work through, but the underlying technology has never been questioned," Quentin Blackford told MedTech Dive.

  Medical Devices

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  TAVR uptake in US cities tied to race, ethnicity and income: JAMA study

  ZIP codes with higher proportions of Black, Hispanic and socioeconomically disadvantaged patients have lower rates of transcatheter aortic valve replacement procedures, according to an analysis of Medicare claims data.

  Medical Devices

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  FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

  The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country. 

  Policy & Regulation

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  Siemens Healthineers projects revenue jump fueled by Varian double-digit sales growth

  The medtech expects its $16.4 billion Varian acquisition to post annual sales growth from 2023 to 2025, leading it to forecast accelerating revenue rises.

  Medical Devices

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  MCIT breakthrough device payment pathway included in Cures 2.0 bill

  Lawmakers on Tuesday introduced a revised MCIT proposal in the next version of the 21st Century Cures Act, following last week's repeal of the final rule by CMS. Industry groups AdvaMed and MDMA both back the legislation.  

  Medical Devices

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  What does J&J's split mean for the medical device business?

  Analysts agree that shedding the consumer health group will help boost pharma and medical device growth. The healthcare giant's move follows two key medtech breakups announced in 2021: GE and Zimmer.

  Medical Devices

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  30% of hospital healthcare workers remained unvaccinated as of September

  Healthcare workers in children's hospitals had the highest vaccination rates, along with those working in metropolitan counties, according to the analysis of Centers for Disease Control and Prevention data.

  Policy & Regulation

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  FDA to regulate lab developed tests in policy reversal

  HHS is withdrawing a Trump-era policy that exempted LDTs from premarket review. The American Clinical Laboratory Association warned continually shifting policies "undermines patient access to lifesaving diagnostics."

  Policy & Regulation

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  Globus in takeover talks with NuVasive to boost spine portfolio: reports

  Truist Securities and Piper Sandler analysts said the deal is unlikely. J.P. Morgan cautioned that earlier orthopaedic takeovers struggled to generate returns.

  Medical Devices

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  BD's $2B annual M&A war chest, connected care devices at heart of growth plan

  Evercore ISI analysts said the targets and messaging were consistent with expectations, while J.P. Morgan questioned why it is taking BD longer than its peers to return margins to pre-pandemic levels.

  Medical Devices

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  FDA questions safety of Philips replacement foam for recalled devices

  The agency has asked Philips Respironics to conduct more safety testing on the sound abatement foam at the center of the sleep apnea and ventilator device recall, but did not recommend that patients stop using the machines.

  Medical Devices

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  Biden nominates Robert Califf to return as FDA head

  If confirmed, the cardiologist would return to lead an agency taxed by a heavy COVID-19 workload and a backlog of initiatives back-burnered amid the pandemic.

  Updated Nov. 12, 2021

  Medical Devices

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  J&J splitting medical device, pharma units from consumer health brands

  The industry giant and mainstay of corporate America will separate its consumer health business from its drug and medical device units, which will retain the J&J brand. 

  Updated Nov. 12, 2021

  Medical Devices

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  CMS repeals MCIT breakthrough device final rule, leaves open other coverage pathways

  The agency on Friday officially rescinded the Medicare Coverage for Innovative Technologies rule due to safety concerns following strong opposition from some healthcare groups, despite strong support for the rule in the medtech industry.

  Updated Nov. 12, 2021

  Medical Devices

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  FDA panel finds need for surveillance of devices from Endologix, Medtronic and others

  Experts convened earlier this month by FDA warned the risks of routine use of Endologix's current endovascular graft device outweigh the benefits.

  Medical Devices

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  After another successful quarter, diabetes tech players look ahead to key product launches

  Dexcom's new G7 CGM system is expected to gain CE mark clearance in Q4, and Insulet's Omnipod 5 insulin pump is on track for FDA clearance and a limited launch by the end of the year.

  Medical Devices

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  Siemens software vulnerabilities potentially put millions of medical devices at risk

  A U.S. cybersecurity agency issued an alert about the vulnerabilities which could allow hackers to disrupt the operation of anesthesia machines and bedside monitors from multiple manufacturers.

  Medical Devices

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  GE unveils plan to spin off healthcare business

  The independent company, expected to be separated by early 2023, is being positioned as having more flexibility to pursue acquisitions as it sharpens its focus on precision health and struggles with supply chain shortages.

  Medical Devices

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  Medtech sounds alarm on semiconductor shortages, asks feds to prioritize chips for medical use

  AdvaMed and several device companies, including BD, Medtronic and Philips, have reiterated to the Biden administration how supply chain constraints are causing an "unsustainable" disruption to the industry.

  Medical Devices

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  FDA labels Ellume's recent COVID-19 Home Test recall Class I event

  The agency said there have been 35 reports of false positive results but no deaths reported. More than 2.2 million devices are being recalled in the U.S.

  Updated Nov. 10, 2021

  Policy & Regulation

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