FDA: Page 73
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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 -
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 -
Alex Wong via Getty Images
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 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
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 -
Brian Tucker/MedTech Dive
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 -
Hahn confirmed as next FDA commissioner in 72-18 Senate vote
Stephen Hahn's swift confirmation won applause from lawmakers, former FDA commissioners and industry groups.
By David Lim • Dec. 12, 2019 -
EC medical device group sheds new light on MDR, IVDR sampling codes
The Medical Device Coordination Group also issued a guidance explaining codes used to define the scope of a notified body's designation.
By Nick Paul Taylor • Dec. 12, 2019 -
Grassley, Warren press FDA to issue over-the-counter hearing aid regulations
The agency missed its estimate that the rules would come out last month, but a spokesperson said that timeline was "not intended to be a precise estimate."
By David Lim • Dec. 9, 2019 -
House bill would speed CMS coverage for breakthrough medtech
The bipartisan legislation, reintroduced on Friday, promises faster access to new medical technologies by requiring Medicare to cover devices approved through FDA's breakthrough pathway during a three-year transitional period.
By Susan Kelly • Dec. 9, 2019 -
FDA proposes alternative 510(k) criteria for MRI coils
The draft guidance would permit manufacturers to use a set of performance criteria to demonstrate substantial equivalence, instead of a direct comparison to a predicate device.
By Susan Kelly • Dec. 9, 2019 -
Impeachment clouds year-end medical device tax repeal, industry priorities
AdvaMed argues the primary obstacle to repealing the tax is not the revenue the government would no longer collect, but a crowded year-end legislative agenda and impeachment proceedings against President Donald Trump.
By David Lim • Dec. 9, 2019 -
Dive Awards
Disruption of the Year: EU MDR notified bodies shortage
The new European Union Medical Device Regulation requires more devices to undergo notified body review than ever before. But there are worries there aren't enough notified bodies to handle the workload.
By Dana Elfin • Dec. 9, 2019 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Dive Awards
Regulatory Development of the Year: 510(k) changes inch along
New efforts by FDA to build out the program come years after the Institute of Medicine recommended scrapping it. More than 80% of devices are cleared through the pathway, so small changes can be meaningful to product safety.
By David Lim • Dec. 9, 2019 -
Kendall Davis/MedTech Dive
Dive Awards
The MedTech Dive Awards of 2019
From TAVR's takeoff to FDA's new approaches to premarket review, these are the industry forces that left their mark on medical technology this year.
Dec. 9, 2019 -
EPA wants more data from ethylene oxide sterilizers, strikes device-friendly tone
Administrator Andrew Wheeler said "medical device sterilization is vital to protecting public health" on release of a notice ahead of rulemaking that could impact sterilizers reliant on the carcinogenic gas.
By David Lim • Dec. 6, 2019 -
FDA grades new Medtronic SynchroMed II recall as Class I event
The voluntary move is the latest in a series of safety actions involving the implantable drug infusion pump, which was the focus of a 2015 consent decree between the company and the government.
By Nick Paul Taylor • Updated Dec. 10, 2019
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