FDA: Page 44
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CMS defends proposal to nix MCIT pathway, medtechs hold out hope
If the bid to repeal the breakthrough payment rule is finalized, the agency's CMO committed to an alternative pathway that evaluates devices for Medicare patients potentially via clinical trials, outcome registries and real-world data.
By Greg Slabodkin • Sept. 29, 2021 -
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FDA medical device regs, safety checks questioned by AMA ethics journal
As it's typically safer to discontinue the use of a drug than an implant, it "might be reasonable" to hold some devices to higher standards, suggests Ariel Wampler, author and plastic and reconstructive surgery physician.
By Nick Paul Taylor • Sept. 29, 2021 -
Explore the Trendline➔
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TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
CDRH's 2021 'reset' shunted again as COVID-19 dominates workload
Jeff Shuren, who spoke during AdvaMed's annual conference, said the heavy coronavirus workload will lead it to miss some MDUFA IV performance metrics.
By Greg Slabodkin • Sept. 28, 2021 -
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FDA starts review after study finds Boston Scientific's Watchman is riskier in women
The agency is working with manufacturers of LAAO devices, a market fought over by Boston Scientific and Abbott, to assess other sources of data before deciding on the next steps.
By Nick Paul Taylor • Updated Sept. 29, 2021 -
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Delta pressure on US hospitals dragged August operations, Kaufman Hall finds
"The August data show we are not out of the woods yet, and hospitals face additional uncertainties as we move into the fall and winter," said Erik Swanson, senior vice president of data and analytics for the consultant group.
By Rebecca Pifer • Sept. 28, 2021 -
Amid pandemic, medtech R&D, merger activity jumped: EY report
Research and development spending at pure-play medtechs rose to a level last seen before the 2007-2008 financial crisis.
By Nick Paul Taylor • Sept. 27, 2021 -
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Medtechs face supply chain disruptions from semiconductor shortage: report
The AdvaMed-commissioned survey found all respondents have experienced some level of disruption to their chip supply chain, with delays ranging from two weeks to more than one year.
By Nick Paul Taylor • Sept. 24, 2021 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.
FDA tells COVID-19 test makers to assess impact of variants in new EUA conditions
The agency's order to assess performance comes amid renewed focus on testing that's seen manufacturers add capacity and land contracts with the federal government worth more than $1 billion.
By Nick Paul Taylor • Sept. 24, 2021 -
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FDA categorizes Cordis catheter recall linked to 8 injuries as Class I event
The recall comes a decade after Cordis flagged up the potential for marker bands to dislodge into the vascular system when the catheter is stretched.
By Nick Paul Taylor • Sept. 23, 2021 -
EU threatens Illumina for closing $8B Grail deal while still under review
The European Commission's warning of fines and other measures is another step in a saga that could run for years. If the bloc ultimately opposes the acquisition, the path forward will be through the courts.
By Nick Paul Taylor • Sept. 22, 2021 -
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Paige's AI-based software gets FDA nod to help doctors identify prostate cancer
It's the latest in a series of milestones for the startup, which has picked up 510(k) clearance for its image viewer, raised more than $220 million and partnered with Philips and Quest Diagnostics in recent years.
By Nick Paul Taylor • Sept. 22, 2021 -
Medtronic embolization device hit with another Class I recall, 2 deaths cited
The action expands a 2020 recall of the brain aneurysm treatment and comes five months after the agency approved an updated version of the technology.
By Susan Kelly • Updated Sept. 22, 2021 -
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Abbott gets FDA nod, faces uphill climb taking on Edwards, Medtronic in TAVR market
The challenge for Abbott as the newcomer is to take share in a relatively mature market dominated by well-set incumbents, without evidence of superiority.
By Nick Paul Taylor • Sept. 21, 2021 -
UK seeks overhaul of AI, software as a medical device regs
The Medicines and Healthcare products Regulatory Agency is slightly ahead of the FDA, which plans to publish draft guidance for AI and SaMD this year.
By Greg Slabodkin • Sept. 20, 2021 -
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FDA policy in response to COVID-19 offers blueprint for regulation of LDTs: study
The agency's response to the pandemic showed it can oversee lab-developed tests, according to Massachusetts General Hospital researchers. They contend that their study could inform legislation aimed at regulating such diagnostics.
By Nick Paul Taylor • Sept. 17, 2021 -
Carol Highsmith. (2005). "Apex Bldg." [Photo]. Retrieved from Wikimedia Commons.
FTC warns app makers fall under breach notification rule
The agency noted that developers of health apps and connected devices are considered healthcare providers. Any unauthorized access, including sharing information without consent, would trigger the Health Breach Notification Rule.
By Shannon Muchmore • Sept. 16, 2021 -
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FDA creates new office to drive forward digital transformation strategy
Vid Desai, who will help lead the new Office of Digital Transformation, was also named as the agency's chief information officer. FDA is seeking an extra $75.9 million in the 2022 budget to support the modernization plan.
By Nick Paul Taylor • Sept. 16, 2021 -
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CMS moves to scrap MCIT rule due to clinical evidence concerns
AdvaMed said the repeal of the Medicare Coverage of Innovative Technology rule is the wrong decision for patients. Analysts wrote the breakthrough device pathway could be resurrected in Cures 2.0 legislation.
By Nick Paul Taylor • Sept. 14, 2021 -
Deep Dive
Medtechs are boosting DTC investment, but industry still years behind pharma
Companies are spending hundreds of millions of dollars every year on direct-to-consumer advertising as the industry focuses on marketing more to patients.
By Ricky Zipp • Sept. 14, 2021 -
MedTech Europe calls for urgent clarification of EU artificial intelligence proposal
The trade group worries "unnecessary overlaps" between the proposed AI Act and medical device regulations, such as MDR and IVDR, could affect access to products as well as lead to legal uncertainty.
By Nick Paul Taylor • Sept. 13, 2021 -
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Abbott, Quest, Quidel likely to benefit from Biden's COVID-19 testing push
Using the Defense Production Act, the White House will push for expanded test production, with $2 billion earmarked to buy nearly 300 million rapid antigen tests for schools, health centers and food banks.
By Greg Slabodkin • Sept. 10, 2021 -
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FDA ends summer with fresh batch of breakthrough device designations
Novocure and CellMax Life are among the latest to get regulatory privileges for experimental devices used to treat and detect cancers.
By Nick Paul Taylor • Sept. 10, 2021 -
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Spine devices, recalls and endovascular stents on FDA's fall meeting lineup
Other topics include Integra's bid for approval of a device used as soft tissue support in post-mastectomy breast reconstruction and a workshop on artificial intelligence and machine learning.
By Nick Paul Taylor • Sept. 8, 2021 -
Permission granted by Texas A&M University
Feds sue UPMC heart surgeon for billing multiple surgeries at same time
The False Claims Act litigation also accuses the health system of ignoring or minimizing complaints by employees and staff.
By Ron Shinkman • Sept. 7, 2021 -
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TransMedics wins FDA nod for donor heart preservation system
Approval for the device comes two months after an FDA advisory panel backed the company's liver preservation system and follows the go-ahead for its donor lung technology in 2019.
By Susan Kelly • Sept. 7, 2021
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