FDA policy in response to COVID-19 offers blueprint for regulation of LDTs: study

The Latest

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  Zimmer latest medtech to warn of delta wave drag in Q3

  The company cautioned that delta variant pressures could extend into the fourth quarter. Despite the warning of the impact on the business, Zimmer's stock price was up nearly 5% Tuesday.

  Medical Devices

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  Patent board issues split decision on key neuromod IP in Medtronic-Axonics dispute

  The PTAB upheld some claims while dismissing others resulting in both the medtech giant and the neuromodulation specialist expressing some satisfaction with the outcome.

  Medical Devices

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  Deep Dive

  Medtechs are boosting DTC investment, but industry still years behind pharma

  Companies are spending hundreds of millions of dollars every year on direct-to-consumer advertising as the industry focuses on marketing more to patients.

  Medical Devices

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  Delta patients clog hospitals, spur more procedure delays

  Intermountain is the latest system to announce it's postponing elective procedures starting Wednesday at 13 of its hospitals, and expects the pause to last several weeks, CEO Marc Harrison said Friday.

  Medical Devices

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  CMS moves to scrap MCIT rule due to clinical evidence concerns

  AdvaMed said the repeal of the Medicare Coverage of Innovative Technology rule is the wrong decision for patients. Analysts wrote the breakthrough device pathway could be resurrected in Cures 2.0 legislation. 

  Medical Devices

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  NuVasive warns of delta hit in Q3 as hospitals once again limit electives

  The company's update offers another early indicator that medtechs will likely be hit in the third quarter due to delta variant surges.

  Medical Devices

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  Jefferies lowers medtech outlooks as hospitals project delta pressure into Q4

  The investment bank lowered its third quarter outlook for medical device companies with revenues heavily based on surgical volumes, including Boston Scientific, Medtronic and Stryker.

  Medical Devices

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  iRhythm announces new CEO, the second since December, amid tumultuous 2021

  Quentin Blackford, who is leaving the position of chief operating officer for Dexcom, will officially take over the role on Oct. 4. iRhythm's stock price shot up by over 34% Monday morning following the announcement.

  Medical Devices

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  MedTech Europe calls for urgent clarification of EU artificial intelligence proposal

  The trade group worries "unnecessary overlaps" between the proposed AI Act and medical device regulations, such as MDR and IVDR, could affect access to products as well as lead to legal uncertainty.

  Medical Devices

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  Abbott, Quest, Quidel likely to benefit from Biden's COVID-19 testing push

  Using the Defense Production Act, the White House will push for expanded test production, with $2 billion earmarked to buy nearly 300 million rapid antigen tests for schools, health centers and food banks.  

  Policy & Regulation

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  FDA ends summer with fresh batch of breakthrough device designations

  Novocure and CellMax Life are among the latest to get regulatory privileges for experimental devices used to treat and detect cancers.

  Medical Devices

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  ResMed touts CPAP survival benefits for sleep apnea after HHS doubts therapy efficacy

  The ResMed-funded analysis of a French database comes on the heels of a government review finding the evidence does not back a link between continuous positive airway pressure therapy and clinically important outcomes.

  Medical Devices

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  Jennifer Doudna-founded CRISPR biotech raises cash to move beyond diagnostics

  Mammoth gained recognition earlier this year by developing a test for COVID-19 based on CRISPR science.

  Diagnostics

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  Spine devices, recalls and endovascular stents on FDA's fall meeting lineup

  Other topics include Integra's bid for approval of a device used as soft tissue support in post-mastectomy breast reconstruction and a workshop on artificial intelligence and machine learning. 

  Medical Devices

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  Humana reports dip in non-COVID-19 Medicare Advantage admissions amid delta surge

  The payer also expects outpatient visits to contract, a trend seen in prior waves of the pandemic.

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  TransMedics wins FDA nod for donor heart preservation system

  Approval for the device comes two months after an FDA advisory panel backed the company's liver preservation system and follows the go-ahead for its donor lung technology in 2019.

  Medical Devices

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  Hospital telehealth leveling off at one-fifth of medical appointments, research finds

  And of the facilities reporting higher virtual volumes, many said they expected telehealth use to decline over the long term, according to the survey from KLAS Research and the Center for Connected Medicine.

  Research

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  Q&A

  Bill Gates-backed Vicarious Surgical targets Intuitive, J&J, Medtronic in abdominal robotic surgery

  The robotics startup, with investors including BD, wants to grow sales to $1 billion by 2027. CEO and co-founder Adam Sachs told MedTech Dive legacy robot platforms have fallen short in terms of cost and efficiency.    

  Medical Devices

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  EU expert panel starts accepting applications to review high-risk IVDs

  The incoming IVD regulation, set to go into effect next May, requires certain diagnostics be reviewed by the committee and/or tested by a reference lab.

  Policy & Regulation

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  Q&A

  ECRI CEO: FDA, industry must revisit COVID-19 medical device EUAs as shortages ebb

  Marcus Schabacker spoke to MedTech Dive about patient safety, cyberattacks in healthcare and risks from the rise of at-home care.

  Medical Devices

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  Feds sue UPMC heart surgeon for billing multiple surgeries at same time

  The False Claims Act litigation also accuses the health system of ignoring or minimizing complaints by employees and staff.

  Policy & Regulation

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  Abbott, Quest, Quidel scramble to add test capacity as delta variant surges

  Quest Diagnostics is adding testing platforms in areas of the U.S. with high demand while manufacturers of at-home coronavirus tests such as Abbott and Quidel are ramping up capacity again after the early summer slump.

  Manufacturing

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  Baxter to buy Hillrom for $10.5B in bid to expand connected care portfolio

  Wall Street analysts and investors had previously questioned the price and strategic fit of a deal, which was rumored for weeks.

  Medical Devices

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  Medicare insolvency still expected by 2026, unchanged by COVID-19, trustees say

  The forecast is a bit of a bright spot for the otherwise grim financial prospects of the program, as experts worried COVID-19 would result in the fund that finances Medicare Part A running out of money faster than previously expected.

  Policy & Regulation

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  Philips cleared by FDA to start repairing recalled sleep apnea devices

  The company expects repair and replacement programs to be completed in the next 12 months. CEO Frans van Houten said in a Wednesday statement that Philips has increased service capacity and patient outreach.

  UPDATED: Sept. 1, 2021 at 10:59 a.m.

  Medical Devices

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