Lawmakers reintroduce diagnostic regulation bill that split the industry

The VALID Act would create a risk-based regulatory framework for in vitro diagnostics and laboratory-developed tests. ACLA, whose members include Quest and LabCorp, is reviewing the bill but has objected to earlier drafts.

By Nick Paul Taylor • June 25, 2021

EU clarifies Eudamed rules for legacy and custom-made devices

The Medical Device Coordination Group has provided information on products placed on the market under frameworks other than MDR and IVDR, which the advisers said should be registered in the database.

By Nick Paul Taylor • June 25, 2021

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

More than 1/3 of health organizations hit by ransomware last year, report finds

Of those attacked, 65% said the criminals were successful in encrypting their data, according to the report from cybersecurity company Sophos.

By Rebecca Pifer • June 24, 2021

Medicare lacks cyber oversight of hospitals' networked medical devices: OIG

Without proper cybersecurity controls, these devices can be compromised with the potential for patient harm, according to the HHS watchdog. OIG wants CMS to do more to address hospital vulnerabilities.

By Nick Paul Taylor • June 24, 2021

Contentious device breakthrough payment rule codified in Cures 2.0 proposal

The measure would sidestep CMS' delay of the MCIT pathway, which grants Medicare coverage to FDA-approved breakthrough devices.

By Nick Paul Taylor • June 24, 2021

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

CEO Scott Whitaker said transport challenges, including shipping container shortages and insufficient trucking capacity, have impeded the ability of medtechs to deliver products while also significantly driving up costs.

By Ricky Zipp • June 23, 2021

Legacy medical devices, growing hacker threats create perfect storm of cybersecurity risks

Aging medtech and increasingly sophisticated criminals are leaving hospitals highly vulnerable to attacks.

By Greg Slabodkin • June 22, 2021

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.

By Samantha Liss • June 21, 2021

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."

By Samantha Liss • June 21, 2021

UnitedHealthcare skimping on COVID-19 test pay: California doctors group

The California Medical Association says UnitedHealthcare still is not covering the cost of all COVID-19 diagnostic testing, despite state and federal guidelines that require the services to be provided at no cost to patients.

By Susan Kelly • June 21, 2021

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

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 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

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

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

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

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

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

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

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

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