Medtronic quarterly revenue misses forecast amid 'catastrophic explosion' in supply chain

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  Appeals court sides with Intuitive over J&J in surgical device patent disputes

  A successful appeal by Ethicon would have affected imports of Intuitive Surgical’s SureForm staplers and associated reload cartridges.

  Medical Devices

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  Medtech companies keep supply, staffing challenges in check even as recession risks loom: analysts

  Companies are coping with factors such as supply disruptions, staffing shortages, inflation and foreign-exchange hurdles, according to William Blair analysts.

  Medical Devices

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  Senate seeks to reform diagnostic oversight via user-fee bill, sparking mixed response

  The revised bill from the Senate features a modified version of the Verifying Accurate Leading-edge IVCT Development Act that split the diagnostic industry when lawmakers previously tried to pass it.

  Policy & Regulation

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  FDA gets over 21,000 medical device reports, including 124 deaths, linked to Philips foam breakdown

  The medical device reports were made between April 2021 and April 2022. Both Philips and the FDA contend that the reporting system has limitations, including the underreporting of events and inaccuracies of reports.

  Medical Devices

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  Edwards posts 97% success rate with tricuspid device in 30-day test as it prepares for Abbott rival

  Edwards' device posted a 97% implant success rate, while Abbott's had a 98% success rate. Both are part of a growing market for transcatheter valve repair devices. 

  Medical Devices

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  Google hires former FDA digital health officer to global strategy post

  In his new role, Bakul Patel will help Google build a unified digital health and regulatory strategy.

  Policy & Regulation

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  Study shows that Abbott's Amulet, Boston Scientific's Watchman devices are riskier for women

  The analysis builds on previous studies showing that left atrial appendage occlusion devices are riskier for women. However, Abbott's recent study shows comparable outcomes for men and women at 18 months.

  Medical Devices

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  FDA user-fee bill goes to House; Senate committee draft revamps diagnostic regulations

  The House Energy and Commerce Committee unanimously passed a bill to reauthorize the FDA’s user-fee amendments for the next five years. A Senate committee draft of the bill would add substantive changes.

  Medical Devices

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  Roundup: As procedures rebound, supply chain, staffing challenges set to continue for medtechs

  Procedure-driven companies saw sales recover at the end of the first quarter, while diagnostics businesses reported increased sales of COVID-19 tests due to the omicron surge in January.

  Updated May 19, 2022

  Medical Devices

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  Medtronic links renal denervation to increased time below blood-pressure threshold

  Results from two studies come after the medtech company had a setback in renal denervation in October. Medtronic is expected to report results from its pivotal trial this year.

  Medical Devices

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  LabCorp becomes first company to get EUA for direct-to-consumer test for flu, RSV, COVID-19

  The kit allows individuals to self-collect nasal swab samples at home to send to LabCorp, which will test for the presence of influenza A and B, respiratory syncytial virus and SARS-CoV-2.

  Policy & Regulation

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  MDUFA V inches closer to approval

  After the FDA was delayed in getting a draft to Congress, committees in the House and the Senate are working on bills to reauthorize the Medical Device User Fee Amendments for another five years.

  Updated May 18, 2022

  Medical Devices

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  Avanos Medical recall gets Class I label from FDA following patient injury, death reports

  The company reported in a recall notice that there have been 60 injuries and 23 patient deaths associated with the Avanos Medical Cortrak 2 Enteral Access System since 2015, according to the FDA.

  Medical Devices

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  Pear more than doubles revenue from last quarter, shares new economic data

  The company is keeping its 2022 revenue forecast of $22 million. Pear also presented economic data, which analysts said would be important in conversations with payers.

  Medical Devices

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  Earnings week 4: Vicarious expects 2024 FDA filing for surgical robot; Steris reports record backlogs

  Vicarious Surgical reaffirmed that it would not be making an FDA submission for its surgical robot until 2024, while Globus Medical and Steris discussed rising procedure volumes.

  Medical Devices

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  FDA posts Class I recall report for 51,000 rapid antigen COVID-19 tests

  Woodside Acquisitions recalled two different rapid antigen test kits last month and sent emails to distributors requesting them to immediately return all unused products for a refund.

  Policy & Regulation

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  Medtronic completes Intersect acquisition following FTC order

  The Federal Trade Commission required Medtronic to divest a subsidiary of Intersect ENT to complete the deal. Medtronic announced the $1.1 billion acquisition last August.

  Updated May 16, 2022

  Medical Devices

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  FDA needs testing enforcement discretion policy to improve crisis response, GAO finds

  The U.S. Government Accountability Office has recommended that the FDA develop a policy about when to start and stop enforcement discretion for unauthorized tests to avoid some of the problems it faced during the pandemic.

  Policy & Regulation

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  Dexcom, Insulet, Tandem start 2022 with revenue growth after weathering omicron surge

  All three diabetes technology companies reported that omicron pressured business in January before easing as the quarter progressed.

  Medical Devices

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  Hospital labor expenses up 37% from pre-pandemic levels in March

  Medtech companies including Edwards Lifesciences and Zimmer Biomet expect pressure from hospital staffing shortages to continue through 2022. They're also monitoring if tightening finances will affect system placements. 

  Policy & Regulation

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  House subcommittee debates device remanufacturing definition, sends user-fees bill to next stage

  Members of the House Subcommittee on Health passed the user-fees bill by a vote of 30-0 Wednesday, sending the legislation to the full House Committee on Energy and Commerce.

  Medical Devices

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  Hologic gets FDA approval to challenge Abbott, Roche in transplant testing market

  The company plans to work toward approvals of transplant assays for other pathogens including the BK virus and Epstein-Barr virus to provide quantitative assessments of potential threats to patients.

  Policy & Regulation

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  Rising Google searches for procedures suggest recovering demand at medtechs: analysts

  Google searches for nonemergent procedures are above pre-pandemic levels, providing another data point to indicate that demand is recovering, according to a Needham report.

  Medical Devices

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  Q&A

  Dexcom Chief Tech Officer Leach discusses G7's European launch and FDA review, expanding Dexcom One

  The executive also comments on the continuous glucose monitor maker's next steps for the G7 system as well as its plans for reaching new patients and expanding to non-diabetic users.

  Medical Devices

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  House user-fees bill details clinical trial diversity, cybersecurity requirements

  The legislation would let the FDA bring in $1.78 billion in fee revenue from 2023 to 2027 to fund the review of medical devices. That amount could increase to $1.9 billion if the agency meets certain performance goals.

  Medical Devices

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