BD's FDA filing to update recalled Alaris pumps delayed by 6 months

The Latest

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  Tracking the impact of coronavirus on the medtech industry

  Among the latest: Abiomed gets its second emergency use authorization, this time for use of its Impella heart pump as an ECMO left ventricular unloading therapy to include patients with pulmonary edema or myocarditis.

  UPDATED: Aug. 4, 2020 at 11:07 a.m.

  Medical Devices

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  House panel asks IG to investigate Trump admin bungling of Philips ventilator deal

  The Subcommittee on Economic and Consumer Policy on Thursday sent a letter to the acting inspector general requesting a probe into findings that HHS overpaid by $500 million in a contract negotiated with the Dutch medtech. 

  UPDATED: Aug. 7, 2020 at 11:06 a.m.

  Medical Devices

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  Guardant growth slows in Q2 but still beats expectations

  The precision oncology company reported a 23% increase in sales, yet refrained from reinstating full-year guidance amid ongoing uncertainty about the impact of COVID-19. 

  Diagnostics

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  BD sales slide below expectations, as COVID-19 antigen test gains momentum

  In the month since the launch of its antigen test, CEO Tom Polen said BD shipped more Veritor readers than in a typical year. Still, the medtech's stock fell 9% Thursday amid pressure on other business lines.

  Medical Devices

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  ResMed beats Street with ventilators driving revenue up 9%, but tailwinds ebbing

  "While we are still working on current and future contracts with hospitals, as well as city and national health authorities for these ventilators, the volumes will be significantly lower in the September quarter," said CEO Mick Farrell.

  Medical Devices

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  Nevro blasts past analyst consensus on rebound in pain procedures

  The spinal cord stimulation device maker contends it picked up market share from rivals such as Abbott, Boston Scientific and Medtronic amid the pandemic.

  Medical Devices

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  7 states ally to buy COVID-19 antigen tests, BD and Quidel to get initial orders

  Frustrated by testing shortages and a lack of federal help, a bipartisan group of governors will ramp up use of the rapid point-of-care diagnostics. But antigen test capacity is "stretched beyond its limits," analysts say.

  Policy & Regulation

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  Livongo scooped up by Teladoc in $18.5B deal

  An explosion in the use of virtual care during the pandemic may have sped up the timeline for the merger. Both companies' share prices are down on the news.

  UPDATED: Aug. 5, 2020 at 11:10 a.m.

  M&A

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  NuVasive's spine robot sees delay, again

  Amid COVID-19 constraints, the Pulse application may not be used in humans until 2022 in a spinal robotics market some analysts call significantly untapped.

  Medical Devices

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  CMS proposes eliminating inpatient-only list, in potential boon for ASCs

  The agency would begin by removing about 300 musculoskeletal-related services, which could further accelerate ambulatory surgery centers' important role as medtech customers.

  Medical Devices

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  iRhythm stock leaps 33% after CMS pitches new reimbursement codes

  Permanent codes validate the digital health company's wearable heart monitoring technology and could drive more widespread adoption for detection of atrial fibrillation and other abnormal rhythms, CEO Kevin King said.

  Digital Health

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  Americas drag on Qiagen as Thermo Fisher deal goes down to the wire

  A hedge fund that owns 8% of Qiagen "fully" expects the Thermo Fisher offer to fail, calling it “wholly inadequate.”

  M&A

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  Zimmer sees COVID-19 backlog worth up to $800M, aims to double Rosa robot volume by year's end

  Like rival Stryker, new placements of the company's robot-assisted knee replacement systems had traction during a second quarter when deferral of elective procedures took away over a third of its typical total revenue.

  Medical Devices

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  Medtech and COVID-19: 6 months into the public health emergency

  MedTech Dive examines where the industry stands with testing and the future of those emergency use-authorized diagnostics, as well as how it's adapting to a rebound in elective surgeries and various supply chain challenges.

  Medical Devices

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  CMS pitches key telehealth changes following Trump executive order

  In its 2021 physician fee schedule, the agency is proposing making permanent almost two dozen new telehealth codes and clarified certain provisions around remote patient monitoring.

  Policy & Regulation

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  Medtronic, in catch-up to Axonics, wins nod for rechargeable bladder and bowel control device

  After leading the sacral neuromodulation market for two decades, Medtronic is defending its turf with FDA approval of a product it contends is 80% smaller than its current device and 50% smaller than Axonics' rechargeable system.

  Medical Devices

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  Device maker Q2 reports show optimism on COVID-19 recovery, but flare-ups keep guidance at bay

  Since March and April lows, business volume has improved sequentially. Still, many medtechs are tightlipped on what that may mean for financial performance for the rest of the year.

  Medical Devices

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  Varian sold to Siemens Healthineers in $16.4B all-cash deal

  Breaking with a trend of smaller medtech deal values in 2020, the pact will see radiation oncology equipment and software maker Varian Medical Systems operate as an independent company under Siemens Healthineers.

  UPDATED: Aug. 3, 2020 at 9:54 a.m.

  Medical Devices

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  Quidel says COVID-19 antigen test buoys 270% rise in rapid diagnostics unit, demand 'more than we can satisfy'

  The company late Thursday reported second quarter total sales of $201.8 million, an 86% increase over the prior year, with strong demand for its PCR and antigen tests for the coronavirus.

  UPDATED: July 31, 2020 at 1:28 p.m.

  Manufacturing

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  Stryker sales slump 24% on elective surgery hits, but Mako robot demand a 'pleasant surprise'

  Looking to the third quarter, "we expect the recovery to continue, but do not expect it to be linear, while local governments deal with varying degrees of resurgences," CEO Kevin Lobo said on an earnings call Thursday. 

  Medical Devices

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  Exact Sciences bets pandemic will accelerate adoption of Cologuard

  The cancer diagnostics company is spending to drive a lasting move from colonoscopies to its at-home screening test, including running a $70 million TV advertising campaign.

  Diagnostics

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  Deep Dive

  Medtechs reboot with patients, providers after elective surgeries bottom out

  Recovery of procedures critical to device companies came quicker than many in the industry expected. Now, device makers are adapting as business volumes normalize and COVID-19 continues to spread.

  Medical Devices

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  J&J gets FDA breakthrough status for robot-assisted ablation device

  The designation gives the product, which combines technologies Johnson & Johnson acquired via takeovers of NeuWave Medical and Auris Health, more regulatory support and potentially speedier review.

  Medical Devices

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  Deep Dive

  Coronavirus testing hits a wall: Where do we go from here?

  As LabCorp and Quest are backlogged in delivering molecular test results, some public health officials are calling for a shift in testing approach from slow and accurate to fast and good enough to meet demand.

  Policy & Regulation

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  Hologic blows away earnings expectations on COVID-19 testing surge

  The manufacturer said it has ramped production capacity to at least 1.5 million coronavirus tests a week, estimating it provided a quarter to a third of the test results delivered in the U.S. during the recent quarter.

  Diagnostics

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