B. Braun infusion pump safety correction linked to 51 complaints, one death

While no devices need to be removed, the FDA labeled the correction a Class I recall due to the risk of injury or death for patients.

By Nick Paul Taylor • Nov. 20, 2023

Q3 recap: Medtech firms grapple with layoffs, GLP-1s and China slowdown

Despite these challenges, companies also flagged improvements in supply chain dynamics and pricing that could boost their earnings.

By Elise Reuter • Updated Nov. 21, 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

FDA acts on industry call for clarity about scope of device shortage reporting rules

The agency posted a final guidance and draft guidance on medical device shortage reporting requirements, addressing industry concerns.

By Nick Paul Taylor • Nov. 17, 2023

FDA seeks feedback on racial bias of pulse oximeters, convenes advisory committee

The agency published a paper on improving the evaluation of pulse oximeters to take skin pigmentation into account.

By Nick Paul Taylor • Nov. 17, 2023

LetsGetChecked secures first FDA authorization for at-home chlamydia and gonorrhea test

Jeff Shuren, director of the Center for Devices and Radiological Health, said the test will give patients “more information about their health from the privacy of their own home.”

By Nick Paul Taylor • Nov. 16, 2023

FDA-ordered report tackles how to manage cybersecurity risks of legacy devices

The report from MITRE proposes multiple actions for protecting older medical devices, including research into more modular devices and collecting data on cyber risks.

By Nick Paul Taylor • Nov. 16, 2023

Vicarious delays surgical robot as integration challenges, R&D cuts slow development

Analysts at BTIG warned the company is “walking a very tight rope” and downgraded the stock.

By Nick Paul Taylor • Updated Nov. 15, 2023

Cardinal’s changes to disposable syringes trigger FDA Class I recall notice

The problem is linked to 15 reports of delayed therapy and 13 reports of inaccurate dispensing.

By Nick Paul Taylor • Nov. 15, 2023

Stolen Medtronic laryngoscopes deemed Class 1 recall

Some of the defective devices turned up on Facebook Marketplace before the posting was taken down, the FDA said in the recall notice.

By Susan Kelly • Nov. 15, 2023

Abbott study links aspirin-free regimen to better outcomes in heart pump patients

An accompanying editorial said the “data provide an opportunity to immediately improve the outcomes of patients implanted with contemporary LVADs.”

By Nick Paul Taylor • Nov. 15, 2023

Large registry study upholds safety findings for Boston Scientific’s Farapulse device

The results, presented at the American Heart Association Scientific Sessions, showed a low rate of adverse events for the pulsed-field ablation treatment.

By Elise Reuter • Nov. 14, 2023

Biden initiative aims to accelerate women’s health research

AdvaMed endorsed the White House effort, stressing the need for equitable development and funding of new technologies.

By Susan Kelly • Nov. 14, 2023

Olympus receives Class I recall label for another bronchoscope safety issue

The company's latest corrective action follows four reports of “endobronchial combustion” during procedures with its bronchoscopes.

By Ricky Zipp • Updated Dec. 21, 2023

Wegovy study details revive debate over GLP-1 impact on devices

The data confirmed a cardiovascular benefit for heart patients and showed the drug could help pre-diabetic patients control their blood sugar.

By Susan Kelly • Nov. 13, 2023

Henry Schein says customer data breached in cyber incident

The company lowered its 2023 sales and earnings forecasts in response to the incident, which took some of its distribution systems offline.

By Elise Reuter • Nov. 13, 2023

A catalyst for quality: FDA’s Voluntary Improvement Program saves time, improves process and enhances patient outcomes

Using ISACA's CMMI framework, medical device manufacturers have seen significant improvements, underscoring the program's positive influence on patient outcomes.

Nov. 13, 2023

Resmed overhauls C-suite, creating 3 posts and parting ways with 2 execs

The company recently laid off 5% of its staff and stopped certain projects to lower operating costs.

By Nick Paul Taylor • Nov. 13, 2023

FDA warns providers about using surgical mesh for breast surgery after BD label update

The regulator reminded providers that there are “no surgical mesh products cleared or approved by the FDA for use in breast surgery.”

By Nick Paul Taylor • Nov. 13, 2023

Illumina explores options for Grail, hires advisers

The company, facing pressure from regulators to divest Grail, also formed a special committee to speed decisions on the fate of the liquid biopsy test maker.

By Susan Kelly • Nov. 10, 2023

J&J orthopedics subsidiary undergoes layoffs at Colorado facility

DePuy Spine will cease manufacturing at the site as the medtech giant restructures its strategy in the sector.

By Joelle Anselmo • Nov. 10, 2023

Acutus laying off 65% of employees to focus solely on Medtronic heart device deal

The company has decided to exit the mapping and ablation business and focus its remaining cash on the Medtronic partnership.

By Nick Paul Taylor • Nov. 10, 2023

4 takeaways from Stryker’s investor day

The company’s expected return to pre-pandemic operating margins, procedure backlogs and weight loss drugs were among the topics discussed at Wednesday’s event.

By Elise Reuter • Nov. 9, 2023

BD’s 2024 forecast comes in ‘well below’ Wall Street’s expectations

Wall Street analysts called out BD’s disappointing 2024 EPS forecast in notes to investors, following a Thursday morning earnings call.

By Ricky Zipp • Nov. 9, 2023

NICE backs use of hybrid closed loop systems for Type 1 diabetes, if companies offer discounts

The group’s recommendation gives around 150,000 people with Type 1 diabetes living in England the chance to access the systems, according to an NHS England official.

By Nick Paul Taylor • Nov. 9, 2023

J&J’s Ottava robot arriving too late to threaten Intuitive: analysts

With J&J years from approval and hospitals committed to the da Vinci system, analysts see little threat to Intuitive for the foreseeable future.

By Nick Paul Taylor • Nov. 9, 2023