The Latest

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  BD names ex-3M exec Ronald Silverman as chief medical officer

  Silverman left 3M three months after the company installed a new leader at its health business.

  Medical Devices

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  FDA weighs in on SoClean’s field correction for CPAP cleaning machines

  SoClean announced a voluntary field action last week to address user complaints related to improper set-up and unauthorized modifications.

  Medical Devices

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  Q&A

  Embecta CEO Dev Kurdikar talks about growth expectations, GLP-1s

  The CEO said the company’s growth expectations have not changed in the near term, even with the rise of weight loss drugs.

  Diabetes

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  Medtronic CEO downplays the impact of obesity drugs on bariatric surgeries, diabetes unit

  The company is the latest medtech to address concerns about how weight loss drugs may impact growth.

  Medical Devices

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  FDA concerned Cardinal Health failed to mitigate risk of incompatible syringes

  Days after posting the Class 1 recall notice, the FDA said changes made to certain syringes could lead to overdose, underdose, or delays in therapy or alarms.

  Medical Devices

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  AstraZeneca creates digital health unit, with big-name partnerships already in place

  Called Evinova, the unit will operate as a separate business within AstraZeneca, which sees digital health solutions as a market primed for growth.

  Clinical Trials

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  Medtronic receives FDA approval for renal denervation device

  The company received approval for the hypertension treatment despite a mixed vote from an FDA advisory panel.

  Medical Devices

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  B. Braun infusion pump safety correction linked to 51 complaints, one death

  While no devices need to be removed, the FDA labeled the correction a Class I recall due to the risk of injury or death for patients.

  Medical Devices

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  Q3 recap: Medtech firms grapple with layoffs, GLP-1s and China slowdown

  Despite these challenges, companies also flagged improvements in supply chain dynamics and pricing that could boost their earnings.

  Updated Nov. 21, 2023

  Medical Devices

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  FDA acts on industry call for clarity about scope of device shortage reporting rules

  The agency posted a final guidance and draft guidance on medical device shortage reporting requirements, addressing industry concerns.

  Medical Devices

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  Q&A

  Abbott Diabetes Care CMO Mahmood Kazemi on expanding CGM access

  Kazemi hopes anyone with diabetes will be able to access the technology, even people who don’t take insulin.

  Policy & Regulation

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  FDA seeks feedback on racial bias of pulse oximeters, convenes advisory committee

  The agency published a paper on improving the evaluation of pulse oximeters to take skin pigmentation into account.

  Medical Devices

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  Top FDA official Woodcock to retire early next year

  The 37-year veteran helmed the agency’s pandemic response, and was a key decision-maker in controversial calls on opioids, an Alzheimer's therapy and muscular dystrophy drugs.

  Policy & Regulation

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  Congress delays Medicare lab payment cuts for one year

  The American Clinical Laboratory Association said it remains focused on getting legislation passed that would mitigate pending Medicare payment reductions.

  Policy & Regulation

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  LetsGetChecked secures first FDA authorization for at-home chlamydia and gonorrhea test

  Jeff Shuren, director of the Center for Devices and Radiological Health, said the test will give patients “more information about their health from the privacy of their own home.”

  Medical Devices

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  FDA-ordered report tackles how to manage cybersecurity risks of legacy devices

  The report from MITRE proposes multiple actions for protecting older medical devices, including research into more modular devices and collecting data on cyber risks.

  Medical Devices

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  Stolen Medtronic laryngoscopes deemed Class 1 recall

  Some of the defective devices turned up on Facebook Marketplace before the posting was taken down, the FDA said in the recall notice.

  Medical Devices

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  Vicarious delays surgical robot as integration challenges, R&D cuts slow development

  Analysts at BTIG warned the company is “walking a very tight rope” and downgraded the stock.

  Updated Nov. 15, 2023

  Medical Devices

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  Cardinal’s changes to disposable syringes trigger FDA Class I recall notice

  The problem is linked to 15 reports of delayed therapy and 13 reports of inaccurate dispensing.

  Medical Devices

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  Abbott study links aspirin-free regimen to better outcomes in heart pump patients

  An accompanying editorial said the “data provide an opportunity to immediately improve the outcomes of patients implanted with contemporary LVADs.”

  Clinical Trials

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  Biden initiative aims to accelerate women’s health research

  AdvaMed endorsed the White House effort, stressing the need for equitable development and funding of new technologies.

  Clinical Trials

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  Olympus receives Class I recall label for another bronchoscope safety issue

  The company's latest corrective action follows four reports of “endobronchial combustion” during procedures with its bronchoscopes.

  Medical Devices

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  Large registry study upholds safety findings for Boston Scientific’s Farapulse device

  The results, presented at the American Heart Association Scientific Sessions, showed a low rate of adverse events for the pulsed-field ablation treatment.

  Clinical Trials

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  Wegovy study details revive debate over GLP-1 impact on devices

  The data confirmed a cardiovascular benefit for heart patients and showed the drug could help pre-diabetic patients control their blood sugar.

  Clinical Trials

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  Henry Schein says customer data breached in cyber incident

  The company lowered its 2023 sales and earnings forecasts in response to the incident, which took some of its distribution systems offline.

  Medical Devices

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