FDA: Page 24
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Why won’t Illumina sell Grail?
While financier Carl Icahn and regulators in the U.S. and Europe want DNA-sequencing company Illumina to divest liquid biopsy company Grail, Illumina’s board won’t budge. Analysts say they may be waiting for the best moment.
By Susan Kelly • 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➔
Sara Silbiger via Getty Images
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 -
Courtesy of Grail
Illumina ordered to divest Grail by FTC on anticompetition concerns
The San Diego-based DNA-sequencing company, which also faces a challenge from European antitrust regulators, said it will appeal the FTC’s order.
By Susan Kelly • 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 -
Neilson Barnard via Getty Images
Illumina urges shareholders to reject Icahn board nominees
The DNA-sequencing company says Icahn’s board nominees don’t understand its business or the regulatory process.
By Susan Kelly • March 31, 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 -
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 -
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 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 -
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 -
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 -
webphotographeer via 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 -
Permission granted by Accelus
Spine robot maker Accelus gains another FDA clearance
The company believes its Remi device, which works with several major imaging systems, can gain traction in the market with its portable design.
By Susan Kelly • March 21, 2023 -
Permission granted by Johnson & Johnson
J&J’s Ashley McEvoy named chair of AdvaMed
McEvoy, who is J&J’s worldwide chairman of medtech, will lead the trade association’s board for the next two years.
By Elise Reuter • March 20, 2023 -
Courtesy of Grail
Illumina, facing Icahn challenge, ‘moving quickly’ on resolution for Grail
The DNA-sequencing company said the activist investor hasn’t offered any better solutions for satisfying regulators’ concerns about the acquisition.
By Susan Kelly • March 20, 2023 -
Justin Sullivan via Getty Images
‘Business as usual?’ Investors weigh in on future of medtech startup financing after SVB collapse
Some VC firms say the impact may be limited, while others expect fundraising challenges to linger.
By Elise Reuter • March 20, 2023 -
YakobchukOlena via Getty Images
Olympus accused of ‘troubling disregard for patient safety’ by FDA after flurry of warning letters
The agency’s investigation included a complaint that cracked endoscope caps caused a patient to suffer esophageal trauma.
By Nick Paul Taylor • March 20, 2023 -
Sarah Silbiger via Getty Images
FDA sets end date for raft of COVID-related shortages that began early in pandemic
Shortages of home-use ventilators and clinical sample concentrators are expected to continue.
By Nick Paul Taylor • March 20, 2023 -
Courtesy of U.S. Food and Drug Administration
Trade group warns FDA human factors proposal is ‘too expansive,’ will strain agency resources
Other groups gave a warmer welcome to the plan, with AdvaMed suggesting specific edits without criticizing the overall approach.
By Nick Paul Taylor • March 17, 2023 -
SHansche via Getty Images
Medtech trade group pushes UK to support ambitious Software as a Medical Device program
Reams of data collected by the National Health Service, paired with advanced work in artificial intelligence at U.K. universities, could make Britain a digital health leader if the government acts.
By Nick Paul Taylor • March 15, 2023 -
Mat Szwajikos via Getty Images
Illumina shares jump 17% after Icahn launches proxy fight
The activist investor said his board nominees would work to prevent Illumina from “sinking further into the quicksand” in a battle with regulators over the Grail acquisition.
By Susan Kelly • Updated March 14, 2023 -
Courtesy of Baxter
Baxter issues urgent correction for ventilation system due to risk of oxygen desaturation
Patients can continue to use the devices if they are checked daily and properly maintained, the company said in an announcement posted by FDA.
By Susan Kelly • March 13, 2023
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