Medtronic ramps up competition for leadless pacemakers with newly approved devices

Medtronic received FDA approval for the first leadless pacemaker in 2016, but faces a new competitor in Abbott, which got the nod for its own leadless device last year.

By Elise Reuter • May 1, 2023

Great Britain proposes allowing CE marks until 2030 to minimize Brexit disruption

The extended timeline to create a new regulatory system in England, Scotland and Wales is intended to prevent medical device shortages.

By Nick Paul Taylor • May 1, 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

Globus shareholders approve share issuance for $3.1B NuVasive purchase

NuVasive’s shareholders also OK’d the merger agreement, bringing the deal a step closer to closing.

By Elise Reuter • April 28, 2023

Dexcom reports ‘growing momentum’ behind G7 launch in first quarter

The CGM launch helped the company add more users than in any other quarter in its history.

By Nick Paul Taylor • April 28, 2023

ResMed device sales jump 43% as supply constraints ease

ResMed’s CEO said “I know we’ll be able to beat [Philips]” when the rival returns to the market after its recall.

By Nick Paul Taylor • April 28, 2023

Illumina gets cybersecurity warning from FDA over sequencing software

The vulnerability could result in an attacker gaining control of an instrument remotely and altering genomic data results, the agency said.

By Susan Kelly • Updated April 28, 2023

3M plans 6,000 layoffs as hospital staffing woes continue to curb procedures

Manufacturing and supply chain “headwinds” hurt operating margins in the first quarter, the company said.

By Peter Green • April 27, 2023

Edwards Q1 revenue boosted by growth at TAVR unit, surgical structural heart business

The company also said it benefited from improved hospital staffing levels that led to a rebound in procedures.

By Nick Paul Taylor • April 27, 2023

Boston Scientific Q1 sales top expectations on ‘healthy’ market demand

As medical procedures pick up pace after the COVID slowdown, the company said it is taking market share in all of its business units.

By Susan Kelly • April 26, 2023

Thermo Fisher reports 9% drop in Q1 revenue, shares slip

The drop in revenue accompanied a 41% decline in net income, with Life Sciences Solutions and Specialty Diagnostics revenue declining by double digits. 

By Peter Green • April 26, 2023

Insulet gets FDA clearance for tubeless pump to eliminate daily shots for basal insulin users

The device, called Omnipod GO, eliminates the need for daily injections for people with Type 2 diabetes, CEO Jim Hollingshead said.

By Elise Reuter • April 25, 2023

GE HealthCare revenue up in first quarter as a standalone company, but shares drop

Steady demand and supply chain improvements have helped it grow the business, even as inflation and foreign exchange rates pressure its income.

By Elise Reuter • Updated April 25, 2023

Know Labs hopes to advance non-invasive glucose sensor with proof-of-concept test

The company wants to use its Bio-RFID technology for glucose monitoring, and recently showed the device could detect and quantify specific molecules in water. 

By Nick Paul Taylor • April 25, 2023

Philips says revenue rises 6%, sees €575M in recall-related legal costs

CEO Roy Jakobs expressed confidence in the company’s outlook for the year ahead and said setting aside the funds to resolve a U.S. class action lawsuit was “an important step.”

By Susan Kelly • April 24, 2023

Graphene ‘tattoo’ pacemaker senses and treats irregular heart beats in rats

While still in early stages of development, the tattoo material can mold to the heart, unlike the more rigid implanted pacemakers used today, reducing some of the problems with traditional and leadless technologies.

By Nick Paul Taylor • April 24, 2023

Medtronic wins FDA approval for long-delayed MiniMed 780G insulin pump

Analysts called the FDA approval a “positive” for Medtronic that “should somewhat aid in a turnaround of its U.S. diabetes franchise.”

By Nick Paul Taylor • April 24, 2023

Alphatec buys robotic spine navigation system for $55M

The spine surgery specialist expects the robotic platform to begin generating revenue in 2025.

By Susan Kelly • Updated April 21, 2023

Lawsuit accuses J&J subsidiary of selling faulty knee replacements

A patient who had DePuy’s Attune knee system implanted, and then replaced when it loosened, claims the company downplayed the risks of the device.

By Elise Reuter • Updated April 21, 2023

Friday Q&A: Abbott’s Vish Charan on muscling into the leadless pacemaker market

Abbott is taking on Medtronic in the market for wireless devices to treat abnormally slow heart rhythms.

By Susan Kelly • April 21, 2023

Report names connected medical devices with the biggest cybersecurity risks

The findings come as medical device makers face upcoming FDA requirements for providing cybersecurity information as part of their pre-market submissions.

By Nick Paul Taylor • April 21, 2023

Nevro names Hologic exec as CEO

Kevin Thornal will take the reins from current CEO D. Keith Grossman, who will retire next week. 

By Elise Reuter • April 20, 2023

Abbott hit with FDA warning letter over unapproved changes to heart disease test

The FDA said that four changes made to the tests “could significantly affect the safety or effectiveness of the devices.”

By Nick Paul Taylor • Updated April 20, 2023

Fresenius flags fault with infusion system acquired last year in $240M deal

Fresenius noted a problem with the devices that can cause loss of power, potentially delaying or interrupting the supply of critical fluids and medications. 

By Nick Paul Taylor • April 20, 2023

J&J study data show dramatic benefit to multiple myeloma cell therapy

A study abstract inadvertently posted online showed J&J and Legend’s therapy, Carvykti, reduced the risk of disease progression or death by more than 70% over standard drugs.

By Ned Pagliarulo • April 19, 2023

Medtronic says it plans more layoffs, declines to specify locations

The company said it began notifying some employees on Tuesday, but would not confirm the number of positions or locations of the jobs that would be cut.

By Elise Reuter • April 19, 2023