FDA: Page 23
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Courtesy of U.S. Food and Drug Administration
Analysis shows paclitaxel-coated devices unlikely to increase death risk, leading FDA to withdraw warning
The FDA’s decision to remove mortality warnings from device labels is a boost to manufacturers of paclitaxel-coated devices.
By Nick Paul Taylor • July 12, 2023 -
Sara Silbiger via Getty Images
J&J Megadyne unit’s electrode pad recall labeled Class I over burn risk
The problem, which can cause third-degree burns, has been linked to 63 injuries and no deaths.
By Nick Paul Taylor • July 12, 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 -
Permission granted by ShockWave
Analysts expect a reimbursement boost for Shockwave coronary artery-clearing device
The analysts think growth expectations for the company are too low and have set their earnings estimate for next year 15% above Wall Street’s consensus.
By Nick Paul Taylor • July 11, 2023 -
Permission granted by Medtronic
Medtronic secures Medicare coverage for MiniMed 780G insulin pump
Medtronic has begun processing orders and will start shipping devices over the next few weeks.
By Nick Paul Taylor • July 10, 2023 -
Adam Berry via Getty Images
European guidelines offer support for renal denervation in hypertension, boosting Medtronic, ReCor
Medtronic hailed the updated guidelines as a “turning point” for the use of renal denervation in treating high blood pressure.
By Nick Paul Taylor • July 6, 2023 -
Courtesy of U.S. Food and Drug Administration
Startup’s fast-acting wound treatment gel gets FDA nod for use in humans
Cresilon raised $25 million last year as part of a push to expand its wound-gel product for animals into human health.
By Nick Paul Taylor • July 5, 2023 -
Getty Images
EU MDR costs could cause device shortages for children, medical groups warn
The cost of certification under new medical device regulations in Europe is a barrier to manufacturers that make devices for small groups of patients, medical associations said.
By Elise Reuter • June 29, 2023 -
Retrieved from Istock.
FDA seeks feedback on technologies that can enable healthcare at home
The FDA is asking the medtech industry for input on how the agency can support development of devices for use in non-clinical care settings and by diverse patient populations.
By Nick Paul Taylor • June 29, 2023 -
Sarah Silbiger via Getty Images
FDA repeats restrictions on NuVasive limb-lengthening device after clearing pediatric use
The agency in March cleared NuVasive to market its Precice limb-lengthening system for use in the femur and tibia of children aged 12 years and up.
By Nick Paul Taylor • June 29, 2023 -
Carol Highsmith. (2005). "The Apex Building" [Photo]. Retrieved from Wikimedia Commons.
FTC proposes updates to merger review that could slow healthcare dealmaking
A new rule proposed by antitrust regulators would ask companies to provide additional information about planned mergers to help the Federal Trade Commission keep pace with increased deal volume and complexity.
By Emily Olsen • June 28, 2023 -
Sarah Silbiger/Getty Images via Getty Images
Teleflex recall of separating vascular catheters labeled Class I event
The company began the recall in May after receiving 83 complaints, including 18 reports of injuries, related to the fault.
By Nick Paul Taylor • June 28, 2023 -
Proposed EtO limits garner criticism from device industry, praise from occupational health groups
Lobbyists representing medical device companies say the proposed policy would reduce capacity at commercial sterilizers by as much as 50%.
By Elise Reuter • June 27, 2023 -
CMS proposes pathway to earlier breakthrough device coverage
The voluntary plan would allow manufacturers to address evidence gaps through studies designed to answer specific questions.
By Susan Kelly • Updated June 23, 2023 -
Retrieved from Owlet on June 22, 2023
Owlet receives FDA clearance for prescription pulse oximetry baby sock
Clearance of the new system settles a controversy that began last year when Owl sold a similar pulse oximetry device over the counter, but was ordered to pull it from sale and seek regulatory approval as a medical device.
By Nick Paul Taylor • June 22, 2023 -
Permission granted by FujiFilm USA/Francisco Gonzalez
OpinionProposed breast cancer screening recommendations don’t go far enough
A proposal by a government-sponsored task force calling for a 24-month spacing between mammograms fails to address the latest research and may further exacerbate disparities and mortality outcomes, argues Henry Izawa, head of FujiFilm Healthcare Americas.
By Henry Izawa • June 21, 2023 -
Permission granted by Taylor Wessing
OpinionThe importance of trust in AI as a medical device
Building trust with patients, as well as regulators, will be key to the adoption of AI in medical devices and diagnostics, argues Alison Dennis, a London-based partner with law firm Taylor Wessing.
By Alison Dennis • June 15, 2023 -
Getty Images
Huma hails 510(k) clearance as boost to digital health product development
The clearance permits Huma to host digital health tools from multiple creators that support screening, diagnosis, dosing recommendations and clinical decisions.
By Nick Paul Taylor • June 13, 2023 -
EPA’s proposed ethylene oxide regulations may cost sterilizers more than estimated: Moody’s
Large commercial sterilizers should be able to handle the increased costs, but smaller companies might have to sell, Moody’s analysts write.
By Elise Reuter • June 9, 2023 -
Courtesy of Cue Health Press Kit
Cue Health wins first non-emergency authorization for COVID test, days after Goldman downgrade
The FDA’s marketing authorization for Cue’s COVID-19 molecular test could boost consumer access, but the company faces strong competition from more established diagnostic firms.
By Peter Green • June 7, 2023 -
Courtesy of iRhythm
FDA: iRhythm targeted heart monitor at ‘high-risk’ patients without seeking clearance
William Blair analysts believe “customers are unlikely to change their usage of Zio AT [heart monitors] over time, making this a resolvable issue.”
By Nick Paul Taylor • June 7, 2023 -
Courtesy of Abiomed/J&J
Abiomed heart pump recall labeled Class I by FDA, no deaths reported
The recall, tied to specific sets of the Impella 5.5 with SmartAssist, comes just months after Johnson & Johnson paid $16.6 billion for Abiomed.
By Peter Green • Updated June 5, 2023 -
Provided by ArcBest
AdvaMed lobbies for medtech companies to be prioritized in global supply chain
The medtech trade group published a white paper outlining supply chain improvements needed to ensure availability of materials and parts for medical devices.
By Elise Reuter • June 2, 2023 -
Permission granted by iRhythm Technologies
FDA hits iRhythm with warning letter over problems at heart monitor facility
iRhythm can continue to manufacture and sell its products and does not expect the warning letter to materially affect its financial results.
By Nick Paul Taylor • June 1, 2023 -
Getty Images
Patient advocacy groups urge FDA to regulate lab-developed tests if VALID Act doesn’t pass
Legislation has been proposed in Congress to bring diagnostic tests under a single regulatory framework, but if it doesn’t pass, the FDA has authority to regulate lab-developed tests, the groups said.
By Elise Reuter • May 31, 2023 -
Getty Images
MedTech Europe sets out position on cybersecurity, making case for reliance on MDR
As the number of connected medical devices grows, the industry group argues that Europe’s new medtech regulations should remain “the primary avenue” for medical device cybersecurity.
By Nick Paul Taylor • Updated June 12, 2023
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