AdvaMed urges Biden to prioritize medical supplies as industries suffer shipping constraints

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  Black patients were more likely to die of COVID-19 largely due to inferior hospitals

  A recent study in JAMA Network Open showed how inequities in housing influence where Black people seek care and how that affects the quality of care they receive.

  Policy & Regulation

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  Medicare CGM eligibility widened in potential boon for Abbott, Dexcom

  CMS opened up coverage for therapeutic continuous glucose monitors, eliminating a rule that patients must use a blood glucose monitor and require at least four self-monitoring blood glucose tests per day to have devices covered.

  Medical Devices

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  The Supreme Court saved the ACA, again. It may not be the last word on challenges.

  Will the 7-to-2 ruling put future efforts on ice? Even staunch backers of the law expect opponents to "come up with something."

  Policy & Regulation

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  FDA seeks feedback on distinction between device remanufacturing and servicing

  The long-awaited draft guidance is meant to clarify a blurry line between the two processes. The Medical Imaging and Technology Alliance contends remanufacturing is being done by unregulated third-party device servicers.

  Medical Devices

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  Hip, knee bundled pay program results similar as voluntary or mandatory: JAMA study

  The results of a University of Pennsylvania analysis of more than a million Medicare claims for joint replacement surgery lend support to CMS' expected policy shift toward more mandatory bundled payment arrangements.

  Medical Devices

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  Roundup: Medtronic's HeartWare HVAD pump recalls and decision to exit

  There's been a whirlwind of regulatory activity around Medtronic's HeartWare HVAD pump. Here's a compendium of MedTech Dive's coverage of FDA recalls and the company's decision to discontinue the system.

  Medical Devices

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  UK extends OK of Innova COVID-19 test criticized by FDA in warning letter

  While U.S. regulators told the public to put Innova tests in the trash, a review by the U.K. counterpart found no problems that warranted further actions.

  Policy & Regulation

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  MedPAC says lower clinical lab fees don't impact access, prompting ACLA ire

  The clinical laboratory group, whose members include Quest and LabCorp, contends that MedPAC's report to Congress contains "biased" commentary that ignores the value of lab tests and importance of timely patient access.

  Policy & Regulation

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  Public Citizen calls for top FDA officials to resign following Alzheimer's drug approval

  The consumer group wants Janet Woodcock, Patrizia Cavazzoni and Billy Dunn to step down over last week's controversial approval of Aduhelm, which is expected to put immense strain on healthcare budgets.

  Policy & Regulation

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  Abbott's Panbio antigen test misses half of asymptomatic COVID-19 cases in Irish study

  The finding led Ireland to recommend against using single, standalone antigen kits for the purposes of such screening.

  Diagnostics

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  LetsGetChecked receives EUA for use of at-home COVID-19 collection kit by minors

  The virtual healthcare company, which last week announced $150 million in Series D financing, is competing with companies including LabCorp for the pediatric testing market.

  Policy & Regulation

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  ResMed's stock climbs following Philips' sleep apnea, ventilator device recall

  Wall Street analysts wrote the recall could drive patients and durable medical equipment providers to ResMed devices, though any benefits right now are "impossible to quantify."

  UPDATED: June 16, 2021 at 10:50 a.m.

  Medical Devices

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  Amazon offers COVID-19 test online to consumers with a website for viewing results

  The tech giant's coronavirus diagnostic, which received FDA emergency authorization in March, was originally designed for use by company employees but is now available for $39.99 to the public.

  UPDATED: June 16, 2021 at 10:43 a.m.

  Policy & Regulation

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  FDA advisory panel to review TransMedics' liver preservation device

  The Gastroenterology and Urology Devices Panel will meet virtually on July 14 to discuss the company's filing for premarket approval of the OCS Liver system, which is designed to keep donor organs viable for longer.

  Medical Devices

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  FDA rejects Verily filing for wrist-worn Parkinson's clinical trial device

  The sister company of Google developed the feature to collect data on the motor function of Parkinson's patients in between visits to trial sites. However, the agency questioned the wearable's ability to have a meaningful effect. 

  Medical Devices

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  Humana acquires Onehome to pursue value-based home health strategy

  The deal for Miramar, Florida-based Onehome follows the insurer's recent purchase of home health giant Kindred at Home for $5.7 billion.

  M&A

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  Medtronic's FDA approval sets up fight for recharge-free pain market

  The medtech sees Vanta helping it gain share in a market it has struggled to penetrate in the past. Abbott Laboratories, Boston Scientific and specialist spinal cord stimulation rival Nevro are also competing.

  Medical Devices

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  EC issues medtech guidance on implant cards required under MDR

  The European Commission detailed information implant manufacturers need to provide under the new rules, while also publishing a document on the European Medical Device Nomenclature and how it relates to IMDRF terminology.

  Medical Devices

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  FDA blasts Innova for shipping unapproved COVID-19 test, using false or misleading labeling

  The agency hit the California-based medtech with a flurry of actions on Thursday, firing off a warning letter alongside notice of a Class I recall and a press release telling the public to stop using the antigen test. 

  UPDATED: June 11, 2021 at 11:43 a.m.

  Policy & Regulation

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  EU provides plan to meet 'serious challenge' of readiness for IVDR

  The document by the Medical Device Coordination Group is designed to ensure "limited resources" are focused on the activities that are critical to being ready by May 2022.

  Policy & Regulation

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  FDA lays out device cybersecurity efforts as feds look to implement Biden executive order

  The president signed an order last month seeking to bolster the nation's cyber posture amid growing threats from hackers. 

  Medical Devices

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  Health data giants Ciox, Datavant merge in $7B deal

  Real-world health data company Datavant and health record IT firm Ciox Health say combining forces will result in the largest health data ecosystem in the U.S. The merger is supported by investors including J&J and LabCorp.

  M&A

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  HHS warns providers, insurers COVID-19 testing must be free for patients

  The American Clinical Laboratory Association, which includes Quest Diagnostics and LabCorp, has complained that guidance on the topic had only served to muddy what they saw as clear congressional mandates.

  Policy & Regulation

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  Medtronic's HeartWare HVAD ending brings questions about $1B acquisition

  Nearly five years after Medtronic's buy of HeartWare International, the medtech giant pulled the flagship product of the deal due to safety risks, ceding the market to rival Abbott.

  Medical Devices

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  'Covid hangover' to spur health costs to rise 6.5% in 2022, PwC poll predicts

  PwC found, however, that a greater reliance on lower-cost sites of care like virtual visits and retail clinics could help offset higher usage of medical services.

  Policy & Regulation

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