Medical Devices: Page
-
Courtesy of Philips
Philips Trilogy Evo ventilators face another Class I recall
More trouble for Philips’ Respironics business as the company flags a problem with ventilators that could lead to under-delivery of oxygen due to inaccurate readings.
By Elise Reuter • April 4, 2023 -
Courtesy of Masimo
Masimo receives De Novo nod from FDA for device designed to detect signs of opioid overdose
The system detects patterns associated with opioid-induced respiratory depression and sends alerts that escalate in line with the risk level.
By Nick Paul Taylor • April 4, 2023 -
Explore the Trendline➔
Sarah Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From the effects of layoffs at the Food and Drug Administration and President Donald Trump’s tariff policies to the top medtech trends of 2026, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Courtesy of Evident/Olympus
Bain acquires Olympus life sciences unit for $3.1B
The company aims to expand its position as a workflow solution provider in life science and industrial markets.
By Susan Kelly • April 3, 2023 -
Medtronic, DaVita launch kidney care joint venture
The new company, called Mozarc Medical, will focus on kidney care technology including home dialysis.
By Elise Reuter • April 3, 2023 -
Permission granted by Tidepool
Deep DiveGrassroots innovation: How a patient-driven device for diabetes won FDA clearance
Tidepool Loop, an automated insulin dosing app based on one developed by the DIY diabetes community, received FDA clearance in January.
By Elise Reuter • April 3, 2023 -
Courtesy of Getinge
Getinge’s quality woes continue: FDA categorizes another heart pump recall as Class I event
The recall is the latest in a series of compliance problems for Getinge, which has had CE marks for two products suspended.
By Nick Paul Taylor • April 3, 2023 -
Permission granted by Philips
Philips CEO Jakobs expects first settlement on respirators this year, Dutch newspaper says
Jakobs said he “hopes and expects” to reach a settlement with the Food and Drug Administration this year; settling suits over alleged medical damages may take longer.
By Peter Green • March 31, 2023 -
Permission granted by Nevro
Q&AFriday Q&A: Nevro CMO tells how the spinal device maker will defend its turf in diabetic pain relief
Dr. David Caraway says Nevro’s device stands apart from competing treatments for painful diabetic neuropathy with its clinical data and approach. The company is also launching a new product.
By Elise Reuter • March 31, 2023 -
Sarah Silbiger via Getty Images
Safety of fixed palatal expanders probed by FDA amid patient lawsuits
The investigation follows lawsuits from patients who say the device damaged their teeth and gums, and eroded their jawbones.
By Nick Paul Taylor • March 31, 2023 -
Courtesy of U.S. Food and Drug Administration
FDA qualifies tool for predicting temperature rise when orthopedic implants enter MRI scanners
Device makers can use the tool to identify femoral nail designs that would be less suitable for use in people who may undergo MRI.
By Nick Paul Taylor • March 31, 2023 -
Getty Images
FDA drafts guidance to ease path to updates for AI-enabled devices
The guidance describes a framework for changes to medical devices that use machine learning.
By Elise Reuter • March 30, 2023 -
Sara Silbiger via Getty Images
Surmodics receives FDA feedback weeks after layoffs
Last month, Surmodics laid off 13% of its workforce, blaming regulatory approval delays, which also halted a $24 million milestone payment from Abbott as the firms work on a treatment for peripheral arterial disease.
By Susan Kelly • March 30, 2023 -
Courtesy of Medtronic
ICU Medical challenges GE HealthCare for Medtronic units valued at $8B: report
Medtronic wants to spin off or sell the two units to focus on faster-growing parts of its business and is talking to potential buyers.
By Nick Paul Taylor • March 30, 2023 -
Getty Images
FDA says it won’t issue ‘refuse to accept’ letters on cyber devices before Oct. 1
Until October 1, the FDA will work with device makers to ensure pre-market submissions have adequate cybersecurity information.
By Elise Reuter • Updated March 30, 2023 -
Getty Images
In a threat to diabetes tech market, scientists use implanted glucose-run fuel cell to power insulin release
If commercialized, the technology could disrupt continuous glucose monitor and insulin pump markets fought over by companies including Abbott and Medtronic.
By Nick Paul Taylor • March 29, 2023 -
Courtesy of Getinge
Getinge heart pump has CE mark suspended by second notified body, halting sales for 3 months
TÜV SÜD took the action over concerns related to risk management, post-market surveillance and vigilance, and the timeliness of field safety corrective actions.
By Nick Paul Taylor • March 28, 2023 -
Permission granted by Abbott
Implantable heart failure sensors cut death risk in study: Abbott
Philip Adamson, chief medical officer for Abbott’s heart failure business, called the finding “profound.”
By Susan Kelly • March 27, 2023 -
Getty Images
Hospitals expect procedures, capital equipment budgets to grow next year: survey
Cash-strapped hospitals say they will continue to ask medical device companies for price reductions and payment flexibilities, a survey by BTIG found.
By Elise Reuter • March 27, 2023 -
Megan Quinn/MedTech Dive
Bill would require Medicare to cover breakthrough devices for four years
The bipartisan legislation, if enacted, would speed the coverage determination process for FDA-approved devices.
By Susan Kelly • March 27, 2023 -
Sarah Silbiger/Getty Images via Getty Images
FDA details plan to end emergency use authorizations
The agency is providing a 180-day transition period for devices that were exempted during the pandemic, and said companies that currently have an EUA should start preparing.
By Elise Reuter • March 27, 2023 -
Courtesy of Antennaware
AntennaWare secures patent for wireless tech designed to unlock implant applications
AntennaWare sees the technology facilitating deep-tissue implants that unlock new ways to monitor and treat disease.
By Nick Paul Taylor • March 27, 2023 -
VCG / Stringer via Getty Images
Intuitive’s ecosystem means it will take J&J, Medtronic years to win surgical robot market share: analysts
The analysts expect Intuitive to retain its leadership position “even as new entrants ramp up their competitive offerings.”
By Nick Paul Taylor • March 24, 2023 -
Courtesy of U.S. Food & Drug Administration
Exactech implants may oxidize, FDA says, warning surgeons not to use any recalled joints
Exactech is recalling knee and total ankle replacements that were packaged in defective bags.
By Nick Paul Taylor • March 24, 2023 -
Courtesy of Medtronic
Medtronic merges robotic, legacy surgery businesses into one unit
The combination comes as Medtronic is going through an “aggressive transformation” intended to reduce complexity and improve capital allocation.
By Nick Paul Taylor • March 23, 2023 -
Getty Images
Deep DiveDelays in reporting led FDA to late cancer warning on breast implants, advocates say
Cases need to be better tracked, and the cancer risks should be discussed with patients prior to surgery, patient advocates and physicians said.
By Elise Reuter • March 22, 2023
Previous
