Policy & Regulation
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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 -
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 -
Explore the Trendline➔
Courtesy of Intuitive SurgicalTrendlineMore mergers, new diabetes devices and the road to MDR: Medtech trends in 2023
Medical device leaders expect financial pressures to ease as companies navigate regulatory changes in Europe, planned spinoffs and product launches.
By MedTech Dive staff -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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 -
Deep Dive
Delays 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 -
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 -
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 -
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 -
‘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 -
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 -
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 -
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 -
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 -
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 -
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 -
Medtech groups lose challenge to digital piracy rule in device repair case
Repair companies will still be able to access and use operating code to fix medical devices, after the court rejected arguments by AdvaMed and the Medical Imaging & Technology Alliance.
By Susan Kelly • March 13, 2023 -
Q&A
Friday Q&A: A regulatory attorney breaks down the EU MDR transition
Amsterdam-based regulatory expert Erik Vollebregt explains the agreement this week to extend the deadlines to comply with the EU’s Medical Device Regulation, and the issues that still need to be addressed.
By Susan Kelly • March 10, 2023 -
QuidelOrtho COVID test is first to win FDA nod via premarket review
Special controls instituted by the FDA as part of the De Novo assessment pave the way for other tests to come to market without pandemic-era Emergency Use Authorization.
By Nick Paul Taylor • March 9, 2023 -
More woes for breast implants, as FDA links procedure to squamous cell carcinoma
Three deaths were related to the cancer cases, the agency said.
By Elise Reuter • March 8, 2023