Outset pauses shipments of dialysis accessory after FDA warning letter, denting sales outlook

The halt prompted the company to predict it will now hit the bottom end of its full-year revenue range, a revision that surprised some analysts.

By Nick Paul Taylor • Aug. 4, 2023

BD prepares for relaunch of Alaris pump, raises revenue forecast

The pump relaunch isn’t expected to contribute much to this year’s revenue, but could help Becton Dickinson reach its long-term financial goals. 

By Elise Reuter • Aug. 3, 2023

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

CMS inpatient final rule will have muted impact on medtech companies, analysts say

The CMS disclosed add-on payments that will continue in 2024 and named products that received approval under the breakthrough devices pathway.

By Nick Paul Taylor • Aug. 3, 2023

Baxter recalls infusion pumps over risk of false alarms

Baxter made a software fix last year after it found pumps weren’t issuing an occlusion alarm. Now, the devices might issue alarms even when there isn’t a blockage.

By Elise Reuter • Aug. 2, 2023

Cooper scraps $875M takeover of Cook Medical business after FTC investigation

The FTC said ending the planned acquisition “ensures that critical reproductive health markets remain competitive.” 

By Nick Paul Taylor • Aug. 2, 2023

Varian logistics slow growth at Siemens Healthineers in Q3

Healthineers has worked through some logistics problems but now faces a race to install Varian equipment at customer sites. 

By Nick Paul Taylor • Aug. 2, 2023

Terumo receives FDA clearance for automated whole blood processing system

The device automates additional steps needed to separate platelets from the rest of the blood, giving blood centers more capacity.

By Elise Reuter • Aug. 1, 2023

Abbott pulls Trifecta heart valves from US market over deterioration rate

The action removes a rival to Edwards Lifesciences and Medtronic for the surgical aortic valve replacement market.

By Nick Paul Taylor • Aug. 1, 2023

Vicarious expects to perform first human procedure with robot next year

The company, after disclosing layoffs in February, said it has gained clarity on its regulatory pathway following pre-submission meetings with the FDA.

By Susan Kelly • July 31, 2023

Integra warns impact of plant closure will continue into 2024, with delays possible

Management has built a buffer into the plan but cautioned unforeseen events could cause its timeline to slip.

By Nick Paul Taylor • July 31, 2023

GE HealthCare oxygen sensor recall gets Class I label from FDA

GE warned that the sensors can limit the effectiveness of cardiac defibrillation, expose patients to electrical currents, or give inaccurate blood oxygen readings. 

By Nick Paul Taylor • July 31, 2023

Thermo Fisher eyes $450M in cost cuts due to slowing demand

The pullback in spending will include layoffs and lower investments in some areas of the business, company executives said.

By Susan Kelly • July 28, 2023

FDA shares draft guidance on studying medtech treatments for opioid use disorder

The FDA aims to address challenges including inaccurate self-reported drug use, missing data and the need to show the durability of the treatment.

By Nick Paul Taylor • July 28, 2023

Dexcom hails CGM share gains as driver of 25% revenue growth in Q2

International market share gains and expanding coverage in the U.S. led the CGM maker to raise its revenue forecast for 2023.

By Nick Paul Taylor • July 28, 2023

Abbott recall of heart catheter categorized as Class I event

Abbott plans to win approval for a modified steerable product and bring it to market as a replacement for the recalled device.

By Nick Paul Taylor • July 27, 2023

Boston Scientific raises full-year forecast again, fueled by strong Q2

The company boosted its outlook for the second consecutive quarter and said patients face waitlists for procedures using its devices.

By Susan Kelly • July 27, 2023

Edwards’ TAVR results hurt by pandemic aftereffects and competition in Q2

Staffing is still not where Edwards “would have projected to be in absence of the pandemic.”

By Nick Paul Taylor • July 27, 2023

Teleflex to expand urology portfolio with $600M acquisition

The company reached an agreement to buy Palette Life Sciences, as it looks to grow through acquisitions.

By Elise Reuter • July 26, 2023

Regulatory specialist pleads guilty to forging FDA clearance letters

The former employee of B. Braun’s Aesculap division admitted creating the letters on FDA letterhead and forging an agency official’s digital signature.

By Susan Kelly • July 26, 2023

FDA adopts new sterilization standard to support switch from ethylene oxide

The regulator said it added the alternative sterilization method to its database in response to pressure to reduce EtO use and to support supply chain resiliency.

By Nick Paul Taylor • July 26, 2023

GE HealthCare plans cost cuts, raises earnings forecast

The company plans to improve its margins by cutting down on service agreements and by driving more efficiency in manufacturing and supply chain.

By Elise Reuter • July 25, 2023

Inspire Medical hires Medtronic veteran as new strategy chief

Carlton Weatherby has been tapped to help the sleep apnea implant maker scale up its business.

By Susan Kelly • July 24, 2023

FDA improves 510(k) turnaround times, but PMA waits hit record high: analysis

The time it took for the FDA to reach 510(k) decisions decreased by 24 days, but the agency is still working through a pandemic-driven backlog of premarket approval applications.

By Nick Paul Taylor • July 24, 2023

BD gains FDA clearance to relaunch Alaris infusion pump after recalls

The company will fix or replace older devices still in use at hospitals as it ramps up to resume sales in its market-leading infusion business.

By Susan Kelly • July 24, 2023

Bariatric surgery slowdown nips Intuitive Surgical’s Q2 procedure growth

New weight-loss drugs are eroding demand for surgical procedures that employ the company’s robotic systems.

By Susan Kelly • July 21, 2023