Friday Q&A: Scripps’ Jay Pandit talks about wearables, decentralized trials and what’s next for digital health

The Latest

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  Watchdog faults FDA for rushing COVID tests to market by easing emergency use rules

  HHS’ Office of Inspector General found that by loosening emergency use authorization requirements to bring COVID-19 tests to market faster, the agency allowed inaccurate tests to be distributed.

  Policy & Regulation

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  Abbott’s FreeStyle Libre linked to 67% drop in hospitalizations for Type 2 diabetes patients: study

  After switching to the continuous glucose monitor, patients had fewer acute diabetes-related events such as severe hypoglycemia and diabetic ketoacidosis.

  Medical Devices

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  Insulet’s Omnipod 5 gains CE Mark for European release

  After months of regulatory delays, Insulet’s newest insulin pump can now be marketed in the U.S. and European Union.

  Medical Devices

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  As deadline for FDA user fees bill nears, Congress weighs continuing resolution

  Reauthorization bill is likely to pass before Sept. 30, but it’s unclear what provisions will be included in the final version, experts said.

  Updated Sept. 22, 2022

  Policy & Regulation

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  Medtronic issues urgent notice about MiniMed insulin pump system vulnerability

  Unauthorized users could hack into the device while it’s being set up, and cause the pump to deliver too much or too little insulin, potentially resulting in outcomes including death.

  Medical Devices

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  Jury decides against Sterigenics in ethylene oxide trial, awarding $363M to the sole plaintiff

  Sterigenics has more than 760 lawsuits pending against it in the local court for toxic emissions previously emitted by the plant.

  Medical Devices

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  J&J opens new research hub near San Francisco

  The roughly 200,000-square-foot facility will house about 400 employees and more than double the size of the drugmaker’s presence in San Francisco.

  Medical Devices

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  Zimmer Biomet gets FDA clearance for Identity shoulder system

  Ivan Tornos, the company’s chief operating officer, said in August that it would be Zimmer’s biggest shoulder launch in five years.

  Medical Devices

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  Hurricane Fiona unlikely to significantly disrupt medical device supply: analysts

  Medtech management teams expect fewer problems than after Hurricane Maria in 2017, noting that Hurricane Fiona is less severe and companies are better prepared.

  Medical Devices

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  Abbott’s latest Amulet-Watchman data show more mixed results for the heart devices

  The latest head-to-head trial adds to the growing rivalry between Abbott and Boston Scientific in the left atrial appendage closure space.

  Medical Devices

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  FDA updates advice about Medtronic endotracheal tubes after Class I recall, patient death reports

  The FDA provided more detailed recommendations on preventing and responding to airway obstruction that may occur when using some Medtronic endotracheal tubes.

  Medical Devices

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  Medtronic starts full US commercial release of updated Evolut TAVR system

  Medtronic expects the device’s new features to increase its share of the multibillion-dollar heart valve replacement market.

  Medical Devices

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  Q&A

  Edwards head of TAVR, Larry Wood, says more urgency needed in treating heart valve disease

  Continued staffing shortages at hospitals are delaying the non-invasive aortic valve procedures for patients in need. 

  Medical Devices

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  Racial bias in pulse oximeters to be subject of FDA panel

  The design of the ubiquitous fingertip monitors has inadvertently caused false blood oxygen readings in darker-skinned patients, a problem the FDA hopes to fix.

  Medical Devices

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  Edwards gets FDA nod for mitral regurgitation treatment

  The approval would bring a U.S. competitor to rival Abbott’s MitraClip device. 

  Medical Devices

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  Baxter’s recall of solution sets used in chemotherapy labeled Class I by FDA amid complaints of leaks

  The regulator says the leaks could kill, but with 83 complaints it has not received reports of patient injuries or deaths.

  Medical Devices

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  FBI warns of cyber risks from legacy medical devices

  Outdated device software can put data, patient safety and hospitals’ operations at risk, the top U.S. law enforcement agency warned.

  Medical Devices

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  FDA eases authorization policy for monkeypox tests as lab group points to ‘lessons learned’ from Covid-19

  Laboratory group says new agency guidance that offers templates and more time to submit data should help test developers.

  Diagnostics

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  Medtech firms increasingly positive about future as staffing, inflation pressures ease, say RBC analysts

  Hospital staffing and supply chain issues are expected to improve, according to comments from Boston Scientific, J&J, Medtronic, and others.

  Medical Devices

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  Tasso’s at-home blood collection lancet wins FDA clearance

  Tasso is pitching the device as an enabler of decentralized clinical trials because it could simplify the collection of blood at home.

  Medical Devices

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  Medtronic reports two deaths related to endotracheal tube recall

  The company also received reports of three injuries related to airway obstruction with the tubes, adding to the company’s recent recall woes.

  Updated Sept. 14, 2022

  Medical Devices

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  Sony partners with hearing aid specialist to enter new over-the-counter market

  Sony has identified the U.S. regulatory change as a chance to use its brand and audio technology to add a new growth driver to its portfolio.

  Medical Devices

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  Edwards updates Sapien TAVR device for greater durability

  The device uses Edwards’ Resilia tissue technology to enable dry storage and potentially extend device durability.

  Medical Devices

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  Investor lawsuit accuses Medtronic of failing to disclose insulin pump problems

  The plaintiffs claim Medtronic failed to disclose that its product quality control systems were inadequate and that it was noncompliant with regulations.

  Medical Devices

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  J&J agrees to settle class action pelvic mesh suits in Australia for more than $200M

  Shine Lawyers, the firm representing the patients, said that the Federal Court of Australia still needs to approve the terms of the agreement.

  Medical Devices

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