Patient deaths called 'injury,' 'other' in FDA medical device database: study

The Latest

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  As Stryker boosted by electives comeback, CEO downplays delta variant risk to procedures

  Kevin Lobo said the uncertainty is "baked in" to the company's forecast, though some analysts noted coronavirus variants cloud the outlook for the rest of the year.

  Medical Devices

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  Boston Scientific tops pre-pandemic results in Q2, expects similar trends in H2

  The company joins a handful of other medtechs seeming to move past the crisis, fueled by the return of elective care. CEO Michael Mahoney expects a "manageable level of COVID impact in the second half of the year."

  Medical Devices

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  GE Healthcare's COVID-19 recovery continues with double-digit growth in imaging, ultrasound

  Second-quarter results reflect the return of elective procedures to pre-pandemic levels. A standout was its pharmaceutical diagnostics business which saw orders grow nearly 50% organically year over year.   

  Diagnostics

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  COVID-19 impact on US healthcare system will stretch for decades, Fitch says

  Over the long term, hospitals will face increased pressure from tight labor and wage markets, especially for experienced staff, as well as rising pharmaceutical and supply chain costs, the ratings agency warned.

  Policy & Regulation

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  Mayo Clinic named U.S. News top hospital for sixth straight year

  The list, which already examines specialty areas like knee replacements, added seven new measures including care for spinal fusion and hip fracture.

  Medical Devices

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  PerkinElmer inks $5.3B takeover of antibody provider BioLegend

  Flush with revenue from COVID-19 testing, the medtech is betting the company can sustain a high growth rate amid competition from BD and Thermo Fisher.

  Research

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  Quidel to transfer heart failure assay to Beckman Coulter to end litigation

  While analysts at Craig-Hallum and William Blair said that they thought Quidel had a solid legal case, the agreement eliminates the remaining risk.

  Legal

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  Boston Scientific, Zimmer Q2 expectations lifted by Abbott, J&J, Intuitive results

  Second-quarter results from Abbott Laboratories, J&J and Intuitive Surgical offer encouragement for the rest of the medtech reporting season, according to BofA Securities analysts. They also expect a "small beat" for Dexcom. 

  Medical Devices

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  Growing cyberattacks on hospitals may soon hit bottom lines, patient care: Fitch

  The increased use of smart monitoring devices, telehealth and other virtual care capabilities are putting patient data at risk, the report said. CT scanners and MRI machines were not necessarily designed with "cyber risk in mind."

  Medical Devices

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  Philips Q2 hit from sleep apnea, ventilator recall overshadows pandemic recovery

  CEO Frans van Houten downplayed the potential of a significant impact on Philips' business. But, Baird analysts contend the company could lose about $800 million in the 12-month repair/replace cycle, with ResMed benefiting.

  Medical Devices

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  Illumina-Grail merger subject of in-depth EU antitrust probe

  European officials opened a three-month investigation of the deal, valued up to $8 billion, due to concerns it may reduce competition in the emerging liquid biopsy market. Illumina vowed to press on.

  Policy & Regulation

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  FDA labels Philips sleep apnea, ventilator recall Class I, ResMed eyes advantage

  The agency notices come about one month after Philips announced the recall and began pulling machines from the market. Rival ResMed said there has been a "considerable increase in demand" for its products since the recall.

  UPDATED: July 23, 2021 at 11:39 a.m.

  Medical Devices

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  CDRH still digging out of backlog caused by COVID-19: Shuren

  "We think it's more important to focus on the submissions we already have in house than to talk about products yet to come before us," the device center chief said. "Hopefully, sometime in 2022 we'll get back on track."

  Medical Devices

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  Abbott latest to report pandemic recovery in Q2 as procedures return, COVID-19 tests drag diagnostics

  While growth was positive across the four major businesses, coronavirus test sales came in at $1.3 billion, far below the $2.2 billion reported in the previous quarter, though ahead of lowered expectations.

  Medical Devices

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  FDA seeks funds, powers to fix 'great weaknesses' in medical device supply chain

  Acting FDA Commissioner Janet Woodcock wants Congress to give the agency "expanded authority to obtain supply disruption notifications for critical devices any time there is the potential for a shortage."

  Medical Devices

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  Intuitive's Q2 robot placements accelerate amid procedure recovery

  While the robotic surgery leader is eyeing the delta variant for potential to curb demand, the company raised its forecast for procedure growth this year. However, the outlook does not reflect significant disruptions.

  Medical Devices

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  J&J medical device sales return to pre-pandemic levels in Q2 as COVID-19 impact wanes

  The company's return to growth, fueled by the recovery of elective volumes, could signal where procedure-dependent medtechs stand as the industry recovers from the effects of the coronavirus.

  Medical Devices

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  Radiation therapy 'under attack' from CMS cuts, professional body warns

  Equipment manufacturers including Varian, ViewRay, Hitachi, Siemens and Elekta are among those that could also be affected by the reimbursement changes.

  Medical Devices

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  PacBio inks $800M Omniome buyout to expand into short-read sequencing

  The acquisition will give Pacific Biosciences access to early-stage cancer screening and recurrence monitoring markets. The bid comes 18 months after Illumina scrapped plans to acquire PacBio amid regulatory pushback.

  M&A

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  Deep Dive

  Medtech M&A expected to be robust in second half after 2021 began with a flurry

  Even after deals already eclipsed last year's numbers, analysts predict robust activity in particular among diagnostics companies flush with cash from 2020's COVID-19 test sales.

  Medical Devices

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  CMS pitches stiffening price transparency fines, halting end of inpatient-only list

  The proposed rule moves hundreds of procedures back to hospitals and reverses a Trump-era regulation that attempted to phase out the inpatient-only list. An ASC representative called the regulatory back-and-forth "jarring."

  Medical Devices

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  Medtech funding surges with early-stage deals

  Robot company CMR Surgical, portable dialysis system maker Quanta Dialysis Technologies and diabetes technology developers were among the biggest recipients of private financing in the second quarter.

  Medical Devices

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  Nevro gets FDA nod for diabetic neuropathy treatment but misses Q2 sales target

  The agency's OK for the spinal cord stimulation device potentially opens a market worth billions of dollars. For now, though, preliminary quarterly revenue came in below its prior forecast.

  Medical Devices

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  Abbott, Intuitive and J&J kick off medtech earnings as COVID-19 bellwethers

  Intuitive and J&J are set to report results this week that will shed light on the recovery of elective procedures, while Abbott will provide insights into the drop in coronavirus test demand.

  Medical Devices

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  Health tracking tech revenue to reach $13B this year amid sustained consumer demand

  Devices like blood glucose trackers, smart thermometers and pulse oximeters are a small but growing slice of the larger consumer tech market, according to the Consumer Technology Association.

  Digital Health

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