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

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➔

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

Friday 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

NuVasive shareholders expected to ‘begrudgingly’ back Globus’ $3.1B takeover amid lack of other bidders

Analysts said “none of the other major strategic players were in a position to bid on NuVasive — either because they were not interested or were financially tied up in other areas.”

By Nick Paul Taylor • March 22, 2023

Medtronic, Nvidia to combine forces on AI devices, allowing users to create new software

The companies are working together to allow physicians and developers to build AI applications for Medtronic devices, beginning with the GI Genius endoscopy platform.

By Elise Reuter • March 21, 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

Boston Scientific, Medtronic expected to quickly capture new atrial fibrillation market: analysts

The companies have acquired pulsed field ablation devices in recent years, but one surgeon told analysts he prefers Boston Scientific’s device as it doesn’t require general anesthesia, leading to faster patient turnaround.

By Nick Paul Taylor • 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