FDA: Page 27
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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 -
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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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 • 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 -
Sarah Silbiger via Getty Images
Medtech trends in 2023Medtech regulation outlook in 2023: Faster approvals among priorities as AI moves to fore
Leaders in the medtech field weigh in on the prospects and challenges for product regulation in 2023.
By Peter Green • Updated Jan. 26, 2023 -
Courtesy of Getinge
Getinge heart pump gets third Class I recall after patient death
Customers were alerted to problems with Cardiosave devices late last year after Getinge received complaints about an issue linked to four serious injuries and one death.
By Nick Paul Taylor • Jan. 26, 2023 -
Courtesy of Insulet Corp.
Insulet reports personal-data leak of 29,000 insulin pump customers
In a recall communication to users, Insulet shared information with its website performance and marketing partners through cookies and other trackers embedded in its website.
By Nick Paul Taylor • Jan. 24, 2023 -
EPA. (2022). "https://www.epa.gov/hazardous-air-pollutants-ethylene-oxide/forms/columbus-nebraska-becton-dickinson-pharmaceutical" [Photo]. Retrieved from EPA.gov.
Ethylene oxide regulation may disrupt device supply, AdvaMed warns White House
The trade group has asked President Joe Biden to consider the potential threat to patient care if facilities are shut down.
By Nick Paul Taylor • Jan. 23, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA demands additional data on Abbott rival to Medtronic balloon, setting back approval timeline
Abbott’s partner Surmodics is “evaluating options” to reduce its spending while preparing a response to the regulator’s requests.
By Nick Paul Taylor • Jan. 20, 2023 -
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Medtech hazards: Problems with Philips’ recall put safety of home-use devices at top of danger list
Patient safety group ECRI is challenging manufacturers to provide easy-to-follow device registration instructions and write simply worded recall notices.
By Nick Paul Taylor • Jan. 19, 2023 -
Courtesy of Abbott
Abbott’s FDA approval for TAVI device tees up challenge to Edwards, Medtronic: analysts
Abbott has captured about 9% of the European market and aims to become a “credible third player” in the U.S.
By Nick Paul Taylor • Jan. 18, 2023 -
Courtesy of U.S. Food and Drug Administration
Rethinking 510(k): Studies show risk of using recalled devices as predicates for FDA clearance
Two studies found devices cleared through the FDA’s 510(k) pathway that listed recalled predicate devices were more likely to face recalls themselves.
By Nick Paul Taylor • Jan. 11, 2023 -
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European Commission formalizes plan to extend MDR transition out to 2027, 2028
Having accepted that notified body capacity “remains insufficient,” the Commission wants to give manufacturers more time to get their devices designated under MDR.
By Nick Paul Taylor • Jan. 9, 2023 -
Sarah Silbiger via Getty Images
Vivos bounces back from FDA rejection to land 510(k) clearance for sleep apnea treatment
Shares in Vivos increased by more than 150% on the day of the news.
By Nick Paul Taylor • Jan. 6, 2023
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