Friday Q&A: Francine Kaufman, Senseonics’ CMO, talks growing users, a 365-day CGM, doctor recruitment

The Latest

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  Medtronic issues Class I recall of implantable cardioverter defibrillators in U.S.

  The devices may deliver a reduced shock during high-voltage therapy, about 79% of the programmed energy.

  Medical Devices

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  As monkeypox cases increase, disease experts lament lack of testing access

  “It’s the same problem that happened with COVID-19. This is exactly identical,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security in Baltimore.

  Diagnostics

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  Roundup: Medical device industry confident it can ride out recession, wary of slowing capital sales

  While companies may weather a recession, they still face challenges like hospital staffing shortages, supply chain disruption and inflation, RBC Capital Markets analysts wrote.

  Updated Aug. 10, 2022

  Medical Devices

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  Boston Scientific says it’s investigating allegations of anti-bribery law violations

  The company says the issue is centered on its operations in Vietnam.

  Medical Devices

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  Eargo’s Q2 revenue slides amid decline in hearing-aid shipments

  The company’s gross system shipments fell by more than 8,000 when compared to the year-earlier period.

  Medical Devices

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  BD begins tender offers for up to $500M in debt to advance repayment strategy

  The spinoff of the diabetes business to form Embecta has provided proceeds that BD plans to use to pay down $1 billion in debt, according to Fitch Ratings. 

  Medical Devices

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  FDA’s hearing-aid guidance clears regulatory review amid push by lawmakers for OTC sales

  The move comes after the agency proposed the creation of a new category of over-the-counter hearing aids in October.

  Medical Devices

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  FDA’s breakthrough device designations poised for another record year

  At the midpoint of the year, the FDA had granted 129 designations, suggesting it will break the previous full-year record of 206.

  Medical Devices

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  Senate passes $740B bill to lower healthcare costs after months of wrangling

  While Republicans successfully challenged a planned $35 insulin price ceiling for patients on private insurance, the law still has implications for makers of diabetes devices.

  Medical Devices

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  Q&A

  Friday Q&A: FDA’s former medical device cybersecurity director says more investment needed in staffing

  The FDA and medtech companies will need more cybersecurity staff to stay ahead of hackers, says Kevin Fu, who is now focused on building that workforce for the government, private sector and academia.

  Medical Devices

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  iRhythm raises 2022 revenue forecast after record number of registrations in Q2

  The cardiac monitor maker increased the low end of its forecast by $5 million, although executives expect a flat third quarter compared to the second quarter due to macroeconomic pressures.

  Medical Devices

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  QuidelOrtho reports 37.5% sales growth in first quarter since $6B merger

  The testing firm is increasing sales after Quidel merged with Ortho, opening opportunities to cut costs and increase point-of-care and molecular diagnostics revenue.

  COVID-19

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  EPA names BD, Edwards and Medtronic on list of higher-risk sterilization facilities

  AdvaMed said ethylene oxide is vital for prevention of serious infections and shutting facilities could disrupt the supply of medical devices.

  Updated Aug. 5, 2022

  Medical Devices

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  Biden administration declares monkeypox a public health emergency

  Federal health officials said Thursday that U.S. monkeypox testing capacity is at about 80,000 tests per week, although only 10% of capacity is currently being used.

  Policy & Regulation

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  SEC accuses surgical implant business of pulling forward sales to hit targets

  According to the SEC, Surgalign, known at the time as RTI Surgical, shipped future orders ahead of schedule to pull forward revenues and mask disappointing sales figures.

  Medical Devices

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  BD’s base business growth in Q3 offset by drop in COVID-19 testing

  The company reported a year-over-year drop of about $224 million in COVID-19 testing revenue compared to 2021, with the testing slowdown expected to continue. 

  Medical Devices

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  ResMed buys Mementor for prescription digital health app, continuing German expansion

  ResMed will integrate the startup into its German operation as a separate business segment and use it as a platform for further digital health development.

  M&A

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  6 questions for the medtech industry if Congress doesn’t reauthorize FDA user fees on time

  If Congress doesn’t pass the legislation before Sept. 30, furloughs and delays lie ahead for the agency.

  Policy & Regulation

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  Hospitals have low level of accountability for connected device breaches

  Of the 43% of organizations that reported a data breach in the past two years, 88% said at least one connected device was a contributing factor to the breach, according to a new report.

  Medical Devices

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  Siemens Healthineers stumbles as lockdowns, falling COVID-19 sales and rising costs hit business

  Lockdowns in China caused a steep decline in equipment orders and a big setback to the firm’s core diagnostic business, even as the company expects to meet full year revenue targets.

  Policy & Regulation

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  Virtual Incision opens new frontier for robotic surgery with space station mission

  Using a grant from NASA, the company will perform a mission on the International Space Station to show its platform’s suitability for long-duration space travel.

  Medical Devices

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  Illumina vows to fight EU efforts to block $8B Grail merger

  Illumina acquired the liquid biopsy company in 2021, despite pending anti-competitiveness investigations on both sides of the Atlantic.

  Updated Aug. 2, 2022

  Policy & Regulation

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  Zimmer Biomet raises revenue forecast on faster-than-expected COVID recovery

  The company saw sales across knee and hip procedures increase, though it still faces foreign currency and supply chain challenges.

  Medical Devices

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  Boston Scientific pays $85M to settle long-running patent dispute with Nevro

  J.P. Morgan analysts said the settlement over spinal cord stimulation devices is “a dollar win for Nevro, but a longer-term competitive loss.”

  Medical Devices

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  North American Diagnostics latest to recall COVID-19 tests, gets Class I label from FDA

  The recall adds to a list of medtech firms that have been forced to withdraw illegally distributed COVID-19 tests, amid concerns they could yield false results.

  Policy & Regulation

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