FDA shares plan for restarting facility inspections, warns backlog will persist into 2022

The Latest

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  NeoGenomics inks $390M Inivata buyout to enter liquid biopsy space

  William Blair analysts wrote that NeoGenomics got a good price by setting the buyout fee last year.

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  AI expected to supplant telehealth as top investment priority in next few years, survey finds

  Philips' Future Health Index surveying almost 3,000 health leaders worldwide also found a surprising focus on delivering environmentally sustainable healthcare by 2024.

  Digital Health

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  AI, digital health feature in latest batch of FDA breakthrough device designations

  The agency granted regulatory privileges to artificial intelligence products, including software designed to enable the early detection of cancer and technology to help surgeons tell if cancer is still present after surgical excision.

  Medical Devices

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  Newer TAVR devices linked to lower rate of permanent pacemaker use: study

  The 1,987-subject study found patients receiving older transcatheter heart valves, such as Edwards Lifesciences' Sapien and Medtronic's CoreValve, required permanent pacemakers at a higher rate than newer-generation THVs.

  Medical Devices

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  Zimmer sees Q1 sales growth after CEO warned of down quarter

  Bryan Hanson cautioned in February the quarter would be more challenging than the fourth due to COVID-19 pressures. The turnaround led the company to issue full-year 2021 guidance, but investors weren't impressed.

  Medical Devices

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  Telehealth use dropped in February for first time since September

  The data suggests a potential slowdown in demand for virtual care services that spiked last year in the early months of COVID-19, according to Fair Health's monthly tracker.

  Digital Health

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  Qiagen braces for COVID-19 testing volatility as sales hold steady in Q1

  Coronavirus-related revenues were flat sequentially, helping the company to grow above its outlook. However, the consistency masks changes in where tests are in demand with region-to-region variability expected to continue.

  Diagnostics

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  Orthopaedic companies project 'return to normalcy' as electives recover in Q1

  J&J, Smith & Nephew and Stryker reported seeing a light at the end of the tunnel during the first quarter as nonessential care rebounded, with a backlog of hip procedures pointing the way forward.

  Medical Devices

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  LabCorp inks $150M takeover of Myriad Genetics autoimmune testing unit

  The diagnostics giant discussed its interest in M&A last week, outlining plans to use up to $2 billion in free cash flow to strengthen its businesses through acquisitions.

  M&A

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  Siemens raises outlook as COVID-19 antigen tests blast past original sales target

  The company's bullish prospect for its rapid antigen test business comes as rivals like Abbott Laboratories and Quidel, which are more exposed to the U.S. market, fell short of expectations in the first quarter.

  Diagnostics

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  Q&A

  Radiology Partners, Aidoc talk AI adoption, handling bias, FDA actions

  While AI and machine learning technologies have gained popularity in the medtech and healthcare industries, the companies intend to further grow usage in radiology with their recent partnership.

  Medical Devices

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  Illumina sues European Commission to block competition probe into Grail buyout

  The EU probe is the latest glitch in the takeover bid, which was panned by Wall Street and also faces scrutiny from the FTC. Analysts have said Exact Sciences could benefit from delays.

  Legal

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  CMS finalizes joint replacement pricing extension with input from medtech industry

  Cowen analysts say the agency's initiative could evolve in ways that put pressure on the prices of orthopaedic devices. However, they contend companies can mitigate that threat by selling more products to customers.

  Medical Devices

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  Hologic, Thermo Fisher cautious on COVID-19 test demand as vaccines roll out

  Hologic CEO Stephen MacMillan told investors late Wednesday demand has fallen significantly since January amid vaccinations. Both companies expect recent M&A to be a crucial part of post-pandemic strategies.

  Diagnostics

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  Roundup: Medtech earnings show early signs of electives return, lingering testing uncertainty

  The industry is reporting an elective care rebound in March after volumes dropped in the winter, while COVID-19 test demand appears to be softening as vaccination numbers grow.

  Medical Devices

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  Smith & Nephew returns to growth as US hip sales surge

  First quarter orthopaedic results saw divergent performance in the knees and hip franchises. CEO Roland Diggelmann noted hip injuries are typically more acute but acknowledged a gap in its U.S. knee portfolio.

  Medical Devices

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  Boston Scientific sees Q1 electives rebound, hints at further 2021 M&A

  With two acquisitions already in 2021, CFO Daniel Brennan said, "We have the appetite, and we have the balance sheet in place to continue to" spend later this year.

  Medical Devices

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  Stryker's Wright costs spur Q1 miss, but robotics orders pick up

  The medtech also raised its full-year earnings outlook, which CFO Glenn Boehnlein said is based on an assumption that the second quarter "has a return to normalcy by the time we get to the end."

  Medical Devices

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  CMS pitches extra year of add-on payments for Boston Scientific, Stryker, other devices

  Boston Scientific's Eluvia drug-eluting stent, Cook Medical's Hemospray and Stryker's SpineJack system are among those that would get the extension under the proposed fiscal 2022 inpatient hospital rule.

  Medical Devices

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  Abbott, Quest look to post-pandemic home testing beyond COVID-19

  With development of at-home coronavirus tests, the companies see opportunities for over-the-counter and direct-to-consumer diagnostics for other diseases and conditions, from respiratory ailments to cancer.

  Policy & Regulation

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  GE Healthcare grows sales as routine screening, elective procedures return

  The results provide further evidence that the resumption of elective procedures has driven up demand for imaging and other healthcare products and services. GE saw volumes return for cardiac, oncology and neurology screening.

  Medical Devices

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  Hospital margins remain narrow in March as COVID-19 financial strain lingers

  Pandemic-related costs continue to depress health system finances, though performance recuperated as outpatient activity increased, Kaufman Hall found.

  Policy & Regulation

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  Philips raises guidance as elective procedures exceed pre-pandemic levels

  The Dutch conglomerate's results follow encouraging rebounds in non-emergency care from Edwards, Intuitive Surgical and J&J. Still, Philips posted a loss from continuing operations. 

  Medical Devices

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  BD files new 510(k) submission for troubled Alaris infusion pump

  The announcement comes after a spate of software and hardware recalls regarding the Alaris system throughout 2020 and 2021.

  UPDATED: April 26, 2021 at 11:23 a.m.

  Medical Devices

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  FDA greenlights device to retrain muscles in stroke patients

  The noninvasive brain-computer interface technology uses data from the uninjured side of a patient's brain to recover motor function in the affected arm and hand.

  Medical Devices

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