FDA: Page 49
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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 7, 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 6, 2021 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Danielle Ternes/MedTech Dive
Q&ADexcom 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 6, 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 2, 2021 -
Sarah Silbiger via Getty Images
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 2, 2021 -
Alex Wong via Getty Images
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 2, 2021 -
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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 2, 2021 -
Abbott
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 1, 2021 -
Permission granted by The Boldt. Co.
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 -
FDA
Q&AFDA 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 -
Courtesy of Abbott
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 -
Permission granted by E.A. Crunden
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 -
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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 -
Stefani Reynolds / Stringer via Getty Images
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 -
An Rong Xu via Getty Images
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 -
Adeline Kon/MedTech Dive
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 -
Courtesy of Siemens Healthineers
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
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