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AdvaMed calls Europe’s MDR extension a ‘strong step forward,’ but warns challenges remain
The extra time to certify medical devices in Europe is intended to prevent shortages, but the regulatory overhaul still poses problems for medtech firms, the U.S. lobbying group says.
By Susan Kelly • March 7, 2023 -
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Medtechs plan to centralize regulatory information management in modernization push: survey
The survey suggests that more than two-thirds of medtech firms need to update and automate their regulatory record-keeping and submission practices.
By Nick Paul Taylor • March 7, 2023 -
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 -
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Medtech industry relieved as Europe’s MDR extension nears final approval
While the extra time to comply is aimed at preventing medical device shortages, the rules have still left some device makers and certifying bodies unclear about how to proceed, says one attorney.
By Susan Kelly • March 6, 2023 -
Win McNamee / staff via Getty Images
Elon Musk’s bid to study brain implant in humans rejected by FDA on safety grounds: report
The FDA reportedly raised concerns about the device’s lithium battery, the potential for its wires to migrate across the brain, and how it would be removed.
By Nick Paul Taylor • March 3, 2023 -
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FDA Class I recalls hit 15-year high in 2022
The jump in activity happened in a year in which the number of all recalls rose by around 10%, including actions by Baxter, Medtronic and Philips.
By Nick Paul Taylor • March 3, 2023 -
Courtesy of Dexcom
Medicare to expand CGM coverage to more Type 2 diabetes patients
The updated policy could double the market for continuous glucose monitors, and will take effect in April.
By Elise Reuter • Updated March 2, 2023 -
Sarah Silbiger/Getty Images via Getty Images
FDA moving ahead with rulemaking on lab developed tests without waiting for Congress: BioWorld
A senior FDA official said the agency cannot “just stand by” given the failure of Congress to pass legislation addressing regulation of the increasingly complex tests.
By Nick Paul Taylor • March 2, 2023 -
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Remote patient monitoring increasingly popular, even as pandemic eases, analysis of insurance claims shows
Cardiologists are the main users of RPM devices, with blood pressure diagnoses accounting for more than half of all claims made in 2021. Diabetes, which accounts for 16% of claims, is the next most active area.
By Nick Paul Taylor • March 2, 2023 -
Megan Quinn/MedTech Dive
AdvaMed unveils policy priorities with focus on breakthrough device coverage, global market access
Congress should also prioritize protecting the medtech manufacturing supply chain and enact diagnostic testing reform, the lobbying group said in releasing a set of nine policy goals.
By Susan Kelly • March 1, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA authorizes first at-home flu-COVID-19 combination test days after its developer files for bankruptcy
Lucira filed for bankruptcy protection last week, saying the “protracted” authorization process caused it to miss out on test sales in the 2022 to 2023 flu season.
By Nick Paul Taylor • Feb. 27, 2023 -
Courtesy of Getinge
Getinge has CE marks suspended on life support sets over sterile packaging issues
Getinge said it is “aware of the severe situation this suspension puts on healthcare and critically ill patients” and is “working urgently to minimize the impact.”
By Nick Paul Taylor • Feb. 24, 2023 -
Courtesy of AliveCor
Biden upholds finding that Apple Watch violated AliveCor’s patents
A ban on the infringing Apple Watches could be enacted under a ruling by the International Trade Commission, but a separate patent case must be resolved first.
By Elise Reuter • Feb. 21, 2023 -
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Device makers gain more time to adapt to Europe’s MDR after EU vote
The European Parliament’s approval means that medtech manufacturers have until 2027 or 2028 to comply with the new rules, depending on device class.
By Susan Kelly • Feb. 17, 2023 -
Courtesy of GE HealthCare
GE’s nuclear imaging device can crush patients, FDA says, as Class I recall issued
GE HealthCare has told customers to stop using the machines until company technicians can inspect them and replace dangerous parts.
By Nick Paul Taylor • Feb. 17, 2023 -
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AI devices need dedicated FDA regulatory pathway to reduce bias risk, say researchers
Scientists argue for a new regulatory process to prevent AI software from reinforcing existing health disparities.
By Nick Paul Taylor • Feb. 16, 2023 -
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Boston Scientific, MDMA call for more transparency and oversight of Medicare Advantage plans
Privately offered Medicare Advantage plans “do not often provide a clear reason for the denial of coverage, and rarely offer any visibility into the evidence and methodology,” trade group MDMA and Boston Scientific said.
By Nick Paul Taylor • Feb. 15, 2023 -
Alex Wong via Getty Images
OpinionPatent trolls’ destructive lawsuits are curbing US medtech innovation
The Patent and Trademark Office must help stop frivolous litigation that is harming the industry, argues former HHS secretary Tom Price.
By Tom Price • Feb. 10, 2023 -
Courtesy of Philips
82 more deaths linked to Philips’ recalled devices reported to FDA, bringing total to 346
The rate of death reports per month has risen consistently since Philips began the recall in the summer of 2021.
By Nick Paul Taylor • Feb. 10, 2023 -
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Abbott balloon device partner Surmodics cuts jobs after FDA approval delay
The workforce reduction, one of a growing number in the medtech sector, comes after the agency requested more data in a premarket review of the company’s device to treat narrowed leg arteries.
By Susan Kelly • Feb. 9, 2023 -
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Biden zeroes in on drug costs during State of the Union address
The president called for extending Medicare's $35 insulin price cap to all Americans and blasted “big pharma” for record profits while at the same time “unfairly charging people hundreds of dollars.”
By Shannon Muchmore • Feb. 8, 2023 -
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Trade group pushes back on FDA’s clinical decision support guidance
The Clinical Decision Support Coalition is asking the agency to rescind its guidance and propose new rules that change how software tools are regulated as medical devices.
By Elise Reuter • Feb. 8, 2023 -
Christopher Furlong via Getty Images
UK health system, under strain, lays out medtech strategy
The state-run National Health Service, now facing a strike by nurses and paramedics, hopes new technologies will help solve some of its long-term challenges to improve patient care.
By Susan Kelly • Feb. 7, 2023 -
Permission granted by GoodRx
FTC orders GoodRx to stop sharing users’ health data with advertisers, issues $1.5M fine
Regulators said they are putting the industry on watch with the enforcement against GoodRx, which allegedly collected data, including patient medications, and shared it without user consent.
By Rebecca Pifer Parduhn • Updated Feb. 1, 2023 -
FDA device center’s 2022 report reveals 37% drop in annual breakthrough designations
The annual report also highlighted the CDRH’s work on pulse oximeters, Philips’ recall of sleep and respiratory devices, cybersecurity and artificial intelligence.
By Nick Paul Taylor • Jan. 31, 2023 -
Patrik Stollarz / Staff via Getty Images
Philips will cut 6,000 more jobs to reduce costs after company swung to net loss in Q4
New CEO Roy Jakobs said Philips has been spreading its resources too thinly and “can't and won't be selling everything everywhere anymore.”
By Nick Paul Taylor • Jan. 30, 2023
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