Surgical gown recall sets Cardinal back $96M

The company estimates a $96 million second quarter charge related to the recall, amid two new field actions affecting procedure kits with the gowns. Cardinal previously saw red flags with the supplier at the root of the problem.

By Nick Paul Taylor • Updated Jan. 31, 2020

HHS price transparency efforts may decode only sliver of total spending

A new analysis focused on non-emergency care that a patient can choose deliberately, such as hip or knee replacements, as opposed to emergency services. 

By Ron Shinkman • Jan. 21, 2020

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

Supreme Court declines to quickly hear ACA case

It's unlikely the case will be decided before the election, which will thrust the debate over the fate of the landmark law into the spotlight during another presidential campaign.

By Samantha Liss • Jan. 21, 2020

UK health authority 'proactively' monitoring breast implant illness reports

In guidance for patients and clinicians on symptoms "sometimes referred to as Breast Implant Illness," the Medicines and Healthcare products Regulatory Agency stopped short of linking the devices to reported illnesses.

By Susan Kelly • Jan. 21, 2020

Virtual, augmented reality in medicine pique FDA's interest

The agency is hosting a workshop Wednesday with representatives from Microsoft, Facebook, Philips and other industry players in hopes of identifying roadblocks to developing more uses of extended reality for medical purposes.

By Nick Paul Taylor • Jan. 17, 2020

ArcherDX, Geneoscopy, Phagenesis win breakthrough device designations

A cancer relapse test, a colorectal cancer screening test and a device to restore swallowing control are among the latest technologies to benefit from certain regulatory perks.

By Nick Paul Taylor • Jan. 15, 2020

Enrollment has ended in Essure postmarket study, FDA says

Bayer discontinued sales of the permanent birth control implant more than a year ago but continues to study its safety profile, as directed by the agency.

By Susan Kelly • Jan. 13, 2020

Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound

FDA's device center issued just nine warning letters in the most recent fiscal year, down from 81 in 2015. But with a major reorganization complete, regulators say they can respond to compliance issues more quickly.

By David Lim • Jan. 10, 2020

MedTech Europe pushes urgent action to keep devices on sale after MDR

The trade group wants the EU to fix perceived problems with the grace period to allow devices to stay on the market and be reviewed by an MDR-designated notified body.

By Nick Paul Taylor • Jan. 9, 2020

FDA sets new date to talk future data strategy

The agency will now convene a public meeting in June, three months after it originally planned, to engage experts on data quality, stewardship, exchange and analytics.

By Nick Paul Taylor • Updated April 28, 2020

EU group offers guidance on meeting MDR's cybersecurity standards

The document says it's important to reference the International Medical Device Regulators Forum's cybersecurity guidance, and policies like the General Data Protection Regulation and the EU Cybersecurity Act "might apply in parallel."

By Susan Kelly • Jan. 7, 2020

Latest FDA clinical decision support software draft a step forward, industry says

The American Medical Association wrote the guide could "lead to the proliferation of CDS tools for 'non-serious conditions' that are faulty, inaccurate, and without validation, potentially leading to patient harm."

By David Lim • Jan. 7, 2020

Industry, doctors, patients diverge on FDA outline for breast implant labels

The Medical Device Manufacturers Association took issue with inclusion of the term "breast implant illness" and called a proposal that manufacturers continually update risk info "impracticable."

By Maria Rachal • Updated Feb. 3, 2020

Providers embrace loosening Stark Law regulations, suggest feds could go further

The Trump administration's proposed relaxation of regulations around the physician self-referral law has nearly unanimous support in both the hospital and physician community.

By Ron Shinkman • Jan. 6, 2020

CMS delays clinical lab fee schedule data reporting, cuts capped at 15% for 2021

The decision to maintain the status quo comes despite labs hoping the agency would freeze rate cuts next year.

By David Lim • Jan. 3, 2020

Notified bodies MedCert, BSI gain new EU MDR and IVDR designations

The European Commission's latest nods bring total notified bodies designated for the Medical Device Regulation to nine and for the In Vitro Diagnostic Regulation to three.

By Nick Paul Taylor • Dec. 31, 2019

FDA creates best practices for combination product developers

The 21st Century Cures Act requires the agency to provide final guidance on aspects of the submission process including how companies should obtain feedback.

By Nick Paul Taylor • Dec. 24, 2019

Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels

The public meetings in some cases instigated voluntary recalls and led to required market removals. Nearly all called for further research or more robust medical device monitoring.

By Maria Rachal • Dec. 23, 2019

Medical device tax disappears, capping decade of industry lobbying

President Donald Trump signed a spending package into law Friday, permanently repealing the ACA tax. The device industry garnered bipartisan backing to nix the 2.3% levy.

By David Lim • Updated Dec. 23, 2019

FTC seeks to block Illumina's $1.2B PacBio acquisition over monopoly concerns

Illumina announced Wednesday it will extend the end time of its merger plan with PacBio to March 31, 2020.

By David Lim • Updated Dec. 19, 2019

CMS wants to overhaul how organs are procured in the US

The agency estimates if all procurement groups met both the new donation and transplantation rate measures, the number of yearly transplants would shoot up more than 15% by 2026.

By Rebecca Pifer • Dec. 17, 2019

Medical device, insurance and Cadillac taxes repealed in year-end spending bill draft

If enacted into the law as expected, it's a victory for AdvaMed in a years-long battle to scrap the 2.3% levy initially established to help fund coverage under the Affordable Care Act.

By David Lim • Dec. 17, 2019

EU Parliament finalizes 4-year MDR delay for some Class I devices

The delay will help slightly reduce the crush of products needing notified body review by May 26, 2020.  

By David Lim • Updated Dec. 17, 2019

Tandem wins FDA go-ahead for 1st interoperable, automated insulin dosing software

The clearance of Tandem's Control-IQ algorithm is part of a broader regulatory vision for people with diabetes to have the freedom to pair their preferred glucose sensing and insulin delivery devices.

By Maria Rachal • Dec. 16, 2019

Boston Scientific gets 1st US disposable duodenoscope clearance

SVP of Endoscopy Art Butcher told investors last June the single-use duodenoscope could represent more than a $1 billion market opportunity.

By David Lim • Dec. 16, 2019