FDA: Page 76
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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The draft guidance would permit manufacturers to use a set of performance criteria to demonstrate substantial equivalence, instead of a direct comparison to a predicate device.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 -
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 -
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 -
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 -
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 -
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 -
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 -
Jacob Bell/MedTech Dive
Vicarious' surgical robot gets FDA breakthrough status
The company also announced Scott Huennekens, former CEO of Google and Johnson & Johnson's robotic surgery joint venture, joined its board of directors.
By Nick Paul Taylor • Dec. 5, 2019 -
Sens. Wyden, Booker push CMS, FTC, insurers on bias in algorithms
The lawmakers want an investigation into how use of the algorithms may lead to discrimination against marginalized populations.
By Susan Kelly • Dec. 4, 2019 -
EU Parliament panel adopts MDR delay for some Class I devices, full nod likely
One committee member called out the unusual nature of making late-in-the-game substantive regulatory changes through the corrigendum, a procedure typically meant for correcting technicalities and inconsistencies.
By Dana Elfin • Dec. 4, 2019 -
FDA commissioner nominee backs 'proactive, not passive' approach to device safety
While Stephen Hahn shed more light on his thoughts on certain medical device topics, he declined to say FDA scientific judgments of medical devices should be held to the same regulatory standards as drugs in response to a question.
By David Lim • Dec. 4, 2019 -
Hospitals sue HHS, warning price transparency rule would chill competition, crash computers
An agency spokeswoman shot back that hospitals "should be ashamed that they aren't willing to provide American patients the cost of a service before they purchase it."
By Samantha Liss • Dec. 4, 2019 -
Contract sterilizer of devices draws FDA warning over validation issues
American Contract Systems received multiple complaints about the presence of foreign matter in sealed sterilization bags, the agency said.
By Nick Paul Taylor • Dec. 4, 2019 -
FDA approves TB test from Qiagen and DiaSorin
The approval could be a win-win for both companies, bringing Qiagen's TB blood test to DiaSorin's Liaison immunoassay analyzers while expanding the testing menu for Liaison.
By Nick Paul Taylor • Dec. 2, 2019 -
With 6 months until new EU medical device rules, what's the state of play?
Preparing for the May 26, 2020, implementation of the EU's Medical Device Regulation hasn't been easy, given the lack of notified bodies designated to review devices under the more stringent standards.
By Dana Elfin • Updated Nov. 26, 2019 -
Mandatory CMS radiation oncology model goes on the backburner
Originally, the agency was eying an implementation date as early as Jan. 1, but the new regulatory agenda lists July 2022 as a target date for the bundled payment model.
By David Lim • Nov. 26, 2019 -
FDA launches pilot to speed new ethylene oxide sterilization methods
Device makers should also reduce paper in packaging "as soon as possible" to trim the amount of the gas required for effective sterilization. The agency also named its innovation challenge winners.
By David Lim • Nov. 25, 2019 -
Retrieved from U.S. Environmental Protection Agency.
AdvaMed lobbied EPA chief Wheeler on cancer report amid delay in ethylene oxide regs
A bipartisan congressional task force is pushing EPA to issue ethylene oxide regulations that rely on EPA's 2016 report on the toxicity of the gas.
By David Lim • Nov. 22, 2019 -
Medtronic's recovering DCB segment scores FDA approval of IN.PACT AV
The approval allows Medtronic to sell the paclitaxel-coated balloon as a treatment for failing arteriovenous access in dialysis patients.
By Nick Paul Taylor • Nov. 22, 2019 -
Rare medical device ban, OTC hearing aids make FDA year-end to-do list
Medical device manufacturers concerned about a federal crackdown on commercial ethylene oxide sterilizers can breathe a sigh of relief as the EPA says a timeline for final regulations remains to be determined.
By David Lim • Nov. 21, 2019 -
Transcatheter device to treat heart failure gets breakthrough designation
BioVentrix is enrolling 120 subjects in a clinical trial meant to support U.S. marketing authorization for its minimally invasive alternative to conventional surgical ventricular reconstruction.
By Nick Paul Taylor • Nov. 21, 2019 -
Trump FDA nominee Hahn advanced by Senate HELP Committee 18-5
Ranking Member Patty Murray said she would not support the nomination due to a lack of a commitment to back regulations to take non-tobacco flavored e-cigarettes that have not gone under FDA review off the market.
By David Lim • Updated Dec. 3, 2019 -
Carolina Liquid gets FDA warning over sale of unauthorized reagents
FDA said Carolina Liquid distributed Class I and II IVD reagents without regulatory clearance. The warning is the latest in a series of letters issued this year to companies for distributing devices without premarket approval.
By Nick Paul Taylor • Nov. 20, 2019 -
AdvaMed wants FDA to define 'significantly' improved for Safer Technologies Program eligibility
Although the trade association said it supports efforts to speed safer medical devices to market, it believes the agency's draft guidance lacks the specificity needed for industry to understand which devices would be eligible.
By David Lim • Nov. 19, 2019
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