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

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

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

How OEMs can budget aftermarket service in a recession

OEMs need to rethink how to deliver scalable, flexible service, especially in economic uncertainty. 

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

Robot maker CMR Surgical appoints new CEO as it looks to ramp system sales

Supratim Bose will now lead the rollout of the company’s Versius system.

By Susan Kelly • March 17, 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

Senseonics grows sales in Q4 despite ‘softer demand’ for CGM implant in US and Germany

Demand in the U.S. was affected by “a little bit of ambiguity on pricing” ahead of a change to Medicare.

By Nick Paul Taylor • March 17, 2023

Medtronic wins CE mark for ablation device, invests in heart failure monitoring company

The Affera system gives physicians a choice between pulsed field ablation and radiofrequency to treat atrial fibrillation.

By Susan Kelly • March 16, 2023

iRhythm COO resigns amid restructuring

Douglas Devine will stay on as a consultant through 2024, as the company goes through a restructuring to become “a larger digital healthcare organization.” 

By Elise Reuter • March 16, 2023

Tandem, targeting Medtronic and Insulet’s turf, links artificial pancreas to improved outcomes in kids

If Tandem can prove to regulators that the system can help manage young children’s diabetes, it could compete with Medtronic and Insulet, which have devices that are indicated for use in kids as young as two years.

By Nick Paul Taylor • March 16, 2023

Getinge buys sterilization firm Ultra Clean Systems for $16M

The Sweden-based company, which already partnered with Ultra Clean as a distributor, said the deal will “significantly expand” its offerings to sterile reprocessing departments.

By Elise Reuter • March 15, 2023

Joint replacement business likely to be busy for the next year or more: BTIG analysts

A backlog of patients and improved staffing at hospitals and surgery centers have the analysts projecting four to six quarters of growth for firms including Stryker and Zimmer Biomet.

By Nick Paul Taylor • March 14, 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

Philips poaches new connected care business leader from Pear

Julia Strandberg, formerly Pear’s chief commercial officer, must revive a division still struggling with the recall of 5.5 million respirators.

By Elise Reuter • March 13, 2023

Silicon Valley Bank’s swift collapse appears to have left established medtech firms untouched

A review of companies covered by analysts reveals no significant direct exposure to SVB’s failure, but startups dependent on venture capital cash may be affected.

By Peter Green • March 13, 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

Insulet to join S&P 500 after Silicon Valley Bank ousted

Shares of the insulin pump maker rose Monday on news that it would join the stock index.

By Elise Reuter • 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