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The Latest

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  Lack of clinical evidence 'major gap' in digital health: study

  The researchers framed the low scores as evidence of “a major gap in health care technology,” adding that there is a “significant opportunity” for companies that differentiate themselves with a more rigorous approach.

  Medical Devices

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  Deep Dive

  As cross-state telemedicine waivers expire, virtual care advocates focus on long-term policy changes

  There’s a complication: No one solution to the U.S.’ patchy physician licensing infrastructure has universal buy-in.

  Policy & Regulation

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  ZimVie faces challenges in focus on slow-growing, 'highly competitive' spine market: JP Morgan

  Still, as a standalone company, the Zimmer spinoff may benefit from tapping higher-growth sub-segments, according to analysts.

  Medical Devices

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  How a sports apparel company helped one Virginia health system pivot to reusable gowns

  Personal protective equipment shortages forced Inova to find new ways to protect workers.

  COVID-19

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  Medical device user fee update inches closer to approval

  After the FDA was delayed in getting a draft to Congress, the House and the Senate are working to pass legislation that would reauthorize the fifth Medical Device User Fee Amendments.

  Updated June 21, 2022

  Medical Devices

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  GE Healthcare says contrast media production back to full capacity

  The shortage of the injectable used for medical imaging started in April, when the company’s plant in Shanghai shut down due to rising COVID-19 cases.

  Updated June 17, 2022

  COVID-19

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  Senseonics lands CE mark for 6-month CGM implant, teeing up Q3 launch in Europe

  Senseonics is looking to the longer-lasting implant to re-energize its fight in a market dominated by Abbott Laboratories and Dexcom.

  Medical Devices

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  Medtronic's Martha says supply chain woes may ease in second half

  The CEO told a conference he’s working on plans to revamp pricing as inflation rises and developing a strategy for advancing robotic surgery.

  Medical Devices

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  Boston Scientific inks $230M deal to buy majority stake in M.I.Tech

  M.I.Tech is a South Korean manufacturer of endoscopic and urologic medical devices. Analysts at BTIG said the deal complements Boston Scientific’s non-vascular stent portfolio and boosts its international presence.

  Medical Devices

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  User fee package goes to Senate with lab-developed test, OTC hearing aid provisions

  The Senate HELP committee passed its version of the FDA user fee bill by a 13-9 vote. It includes an overhaul of diagnostic testing regulations and a requirement to create a category of over-the-counter hearing aids.

  Medical Devices

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  ResMed to acquire German health software company MediFox for $1B

  The acquisition continues a pattern of medical device companies buying software platforms. ResMed expects the deal to close by the end of the year.

  Medical Devices

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  Medtronic: No new patient injury, death reports since April letters warning of HVAD defect

  The company’s HeartWare Ventricular Assist Device System received a Class I label from the FDA following two patient injuries and one death.

  Updated June 14, 2022

  Medical Devices

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  Apple Watch monitoring features for AFib, Parkinson's cleared by FDA

  With the new feature, atrial fibrillation patients may have an easier way to track the frequency of the condition over time and see whether lifestyle changes may have positive effects.

  Medical Devices

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  Dräger's breathing system filter recall gets Class I label from FDA after ventilation obstruction

  An obstruction in one of the company’s SafeStar 55 devices resulted in a patient being resuscitated after becoming hypoxic.

  Medical Devices

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  Medical device companies to curb spending as recession threat clouds longer-term outlook: analysts

  The supply chain and inflation issues that have affected medical device companies in the first half of 2022 likely will persist through the rest of the year, according to RBC Capital Markets.

  Medical Devices

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  ResMed warns supply constraints may last 18 months after Philips completes recall of sleep-apnea devices

  Analysts at William Blair expect ResMed to achieve “durable market share gains, bordering on permanent” because of Philips’ recall, which affects millions of sleep-apnea and ventilator devices.

  Medical Devices

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  Oracle closes $28B buy of 'huge growth engine' Cerner

  With the deal’s close, the days of standalone EHR vendors are increasingly in the rearview mirror.

  M&A

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  UnitedHealth links CGM use in people with Type 2 diabetes to improved blood sugar control

  J.P. Morgan analysts said they see the results as evidence that continuous glucose monitors have a role to play in support packages for people with Type 2 diabetes.

  Medical Devices

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  House passes FDA user-fee package, bolstering cybersecurity, clinical trial diversity for medical devices

  By a 392-28 vote, the House of Representatives passed its version of the legislation, which would renew the Food and Drug Administration's ability to collect user fees for the next five years.

  Medical Devices

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  Insulet targets competitive conversions as Omnipod 5 insulin pump nears full launch

  The company said at a conference it aims to increase the rate of insulin pump use among people with Type 1 diabetes in the U.S. 

  Medical Devices

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  GE Healthcare's recall of ventilator batteries gets Class I label from FDA over device shutdown risk

  Ventilators risk shutting down prematurely — cutting the flow of oxygen to patients — as backup batteries may run out of power earlier than expected.

  Medical Devices

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  FDA mulls pilot program on alternative sterilization for medical devices

  The proposed initiative is a response to global supply chain constraints and is intended to support sterilization supply chain resiliency, the agency said. 

  Medical Devices

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  BD to acquire Parata for $1.53B as part of strategy to boost margins

  The deal is expected to help Becton Dickinson reach its goal of a 25% operating margin by the end of 2025. J.P. Morgan analysts said it would be the most meaningful tuck-in deal since BD acquired Bard in 2017. 

  Medical Devices

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  Q&A

  Dexcom CEO Sayer on G7 FDA submission, developing a 15-day sensor, M&A plans

  Kevin Sayer spoke about the company's back-and-forth with the FDA on the G7 CGM system, possibly expanding from a 10-day to a 15-day sensor and on a report that Dexcom was in talks to buy Insulet.

  Medical Devices

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  Pear sets out payer strategy as it seeks to quadruple prescriptions of digital therapeutics

  Pear shared real-world data that linked its digital therapeutic for substance use disorder to an estimated $3,591 reduction in per-patient costs.

  Medical Devices

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