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.
By Ricky Zipp • June 18, 2021 -
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.
By Nick Paul Taylor • June 18, 2021 -
Explore the Trendline➔
Adeline Kon/MedTech Dive
TrendlineHow medtechs are navigating the sales environment after the pandemic
The impact of the pandemic on the industry was far from even, given the diversity of companies in the space — from those that make heart valves to artificial hips and knees to robotics to point of care testing.
By MedTech Dive staff -
Jacob Bell
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The long-awaited draft guidance is meant to clarify a blurry line between the two processes.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.
By Nick Paul Taylor • June 18, 2021 -
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.
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Alex Wong via Getty Images
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.
By Susan Kelly • June 16, 2021 -
Jacob Bell / BioPharma Dive
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.
By Jacob Bell • June 16, 2021 -
Sarah Silbiger via Getty Images
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.
By Nick Paul Taylor • June 16, 2021 -
Stefani Reynolds / Stringer via Getty Images
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.
By Nick Paul Taylor • June 16, 2021 -
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.
By Nick Paul Taylor • June 15, 2021 -
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."
By Ricky Zipp • UPDATED: June 16, 2021 at 10:50 a.m. -
Sarah Silbiger via Getty Images
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.
By Nick Paul Taylor • June 14, 2021 -
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.
By Nick Paul Taylor • June 14, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
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.
By Nick Paul Taylor • UPDATED: June 11, 2021 at 11:43 a.m. -
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.
By Nick Paul Taylor • June 11, 2021 -
Retrieved from C-SPAN on February 23, 2021
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.
By Greg Slabodkin • June 10, 2021 -
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.
By Nick Paul Taylor • June 10, 2021 -
Jacob Bell / BioPharma Dive
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.
By Greg Slabodkin • June 09, 2021 -
Fotolia
'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.
By Hailey Mensik • June 09, 2021 -
Justin Sullivan via Getty Images
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.
By Nick Paul Taylor • UPDATED: June 16, 2021 at 10:43 a.m. -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.
OraSure gets EUAs to enter shrinking COVID-19 antigen test market
The technology is differentiated from other rapid antigen tests but is coming to market amid what Abbott characterized as a "sharp and rapid" drop in demand.
By Nick Paul Taylor • June 08, 2021 -
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.
By Ricky Zipp • June 08, 2021 -
Medtronic lands FDA approval for brain stimulation leads it expects to drive share gains
CEO Geoff Martha has boasted the nod for SenSight will help it close "a key competitive gap." The medtech competes with Abbott and Boston Scientific in the market.
By Nick Paul Taylor • June 08, 2021 -
Sarah Silbiger via Getty Images
Cancer tech dominates FDA's latest batch of breakthrough devices
The agency's recent breakthrough designations feature a clutch of oncology devices and diagnostics from companies including Viome and Avenda Health.
By Nick Paul Taylor • June 07, 2021 -
UnitedHealthcare to crack down on ER visits, potentially exposing patients to bigger bills
If the largest private payer finds the trip was not an emergency, the visit will be "subject to no coverage or limited coverage," the provider alert states. Anthem faced backlash for a similar policy several years ago.
By Samantha Liss • June 04, 2021 -
Alex Wong via Getty Images
CMS' Fowler: More mandatory payment models likely
"I recognize those come with their own set of disadvantages ... But I support this direction," CMMI head Elizabeth Fowler said Thursday.
By Rebecca Pifer • June 03, 2021
