Policy & Regulation: Page 2

FDA flags biocompatibility concerns linked to NuVasive's Precice devices

The agency is recommending physicians stop implanting new stainless steel devices. NuVasive voluntarily removed the products from the U.S. market in February.

By Nick Paul Taylor • July 09, 2021

Quidel COVID-19 PCR recall dubbed Class I by FDA due to false negative risk

The diagnostic company said it worked with FDA to confirm "a rare potential" for false test results and that the notice alerts lab customers of label changes made two months ago with no products removed from shelves.

By Nick Paul Taylor • UPDATED: July 9, 2021 at 8:57 a.m.

Explore the Trendline➔

Trendline

How 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

EU experts challenge notified body in first opinion on clinical evidence under MDR

The independent panel wants to see an extended study with at least another four months of data on the Class III implantable xenogeneic bone graft. This is the first real-world look at the scrutiny process mandated by the new rules.

By Nick Paul Taylor • July 07, 2021

FDA finalizes guidance on form, content of unique device identifiers

The final text responds to, but in some cases holds firm against, concerns raised by groups including AdvaMed about the 2016 draft and also adds a new section on standalone software.

By Nick Paul Taylor • July 07, 2021

As EU-wide health technology oversight law nears passage, industry is not pleased

If passed, the legislation mandates European Union clinical assessments of certain medical devices to inform national-level pricing and reimbursement decisions.

By Nick Paul Taylor • July 06, 2021

Q&A

Dexcom CEO on the Type 2 population, the Super Bowl ad and pandemic momentum

Kevin Sayer called Type 2 a "tremendous market opportunity" and said direct-to-consumer advertising is worth some controversy.

By Ricky Zipp • July 06, 2021

Anticipated rule bans surprise billing, but mum on arbitration details

"We certainly have to work on this whole issue of arbitration, and the cost. There will be a need to make further clarifications on definitions," HHS Secretary Xavier Becerra told reporters Thursday.

By Rebecca Pifer • July 02, 2021

Neuromodulation and cancer devices feature in latest batch of FDA breakthrough nods

Neuroelectrics, Neuros Medical and Onward are among those that secured the regulatory privilege, which speeds the review process for unmet medical needs.

By Nick Paul Taylor • July 02, 2021

Biden admin unveils new ESRD payment model in health equity push

Tweaks to the end-stage renal disease model alter scoring methodology to incentivize dialysis providers to lower disparities in home dialysis and kidney transplant rates among patients from disadvantaged communities.

By Rebecca Pifer • July 02, 2021

PMA apps could hit record in 2021, pressuring a pandemic-stressed FDA

Despite increased workloads from the coronavirus crisis, the agency is also on track to issue record numbers of safety warnings and letters to healthcare providers in 2021, according to a Wells Fargo analysis.

By Nick Paul Taylor • July 02, 2021

COVID-19 antigen testing on par with PCR when used often: NIH-funded study

The two diagnostic methods were equally effective in detecting SARS-CoV-2 infection. The results could be good news for antigen test makers Abbott, Becton Dickinson and Quidel.   

By Greg Slabodkin • July 01, 2021

U.S. News hospital rankings to add back surgery, hip fracture and overuse

The publication will rank seven new procedures and conditions, as well as a new category "because a pattern of overuse or low-value care is not compatible with being a high-quality provider."

By Hailey Mensik • June 30, 2021

Q&A

FDA wants to require timely updates, patches for legacy devices: cyber chief

Kevin Fu, acting director of device cybersecurity, spelled out the agency's plans to protect aging devices from hackers. There's no current statutory requirement compelling manufacturers to address the problem.

By Greg Slabodkin • June 30, 2021

Abbott gets CE mark to sell COVID-19 antigen test directly to consumers in Europe

The company's rapid Panbio diagnostic received the marking in January for asymptomatic coronavirus screening. However, the test missed half of COVID-19 cases in people without symptoms, according to a recent Irish study.  

By Greg Slabodkin • June 28, 2021

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

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

Deep Dive

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