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

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

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Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

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

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

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

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