Eargo reaches financing deal as it looks to regain insurance coverage after DOJ settlement

The Latest

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  Roundup: Medtronic's HVAD recall problems continue following patient injuries, deaths

  One year after Medtronic pulled the heart pump off the market, there have been two Class I recalls following reports of patient injuries and deaths. Here is a collection of MedTech Dive's coverage of the HVAD saga.

  Updated June 27, 2022

  Medical Devices

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  UnitedHealth's Optum looks to cut down on unnecessary lab testing

  Optum says roughly 13 billion clinical lab tests are performed each year and 30% are unnecessary.

  Policy & Regulation

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  Supreme Court overturns Roe v. Wade, ending constitutional right to abortion

  26 states are certain or likely to end abortion rights, making abortion effectively illegal in half of the country, according to the Guttmacher Institute.

  Policy & Regulation

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  Medtech M&A falls 85% but activity could rebound in second half: report

  PwC highlights a range of barriers that could stop acquisitions, including supply chain issues, scrutiny from the Federal Trade Commission and geopolitical concerns.

  Medical Devices

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  Baxter ventilator recall labeled Class I event by FDA after 2 deaths

  Baxter initiated the recall after learning that an improper setup could reduce oxygen flow to in-home users, causing serious injury or death.

  Medical Devices

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  Patient death prompts another recall of Medtronic's HVAD System

  The company initiated another recall for the troubled heart pump after a patient died when two batteries simultaneously stopped working, the company said, adding to a list of safety problems with the device.

  Medical Devices

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  Bioventus agrees to staggered payment plan to close stalled $315M CartiHeal takeover

  Rising interest rates quashed a plan for Bioventus to fund the takeover of the joint repair company with a bond offering. Now, the deal will get much more expensive, J.P. Morgan analysts said.

  Medical Devices

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  FDA opens consultation on tissue removal devices to reduce cancer risk

  The agency is seeking feedback on draft guidance to help manufacturers of tissue containment systems reduce risk that cancerous tissue could leak during procedures.

  Medical Devices

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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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