Abbott wins FDA spinal cord stimulation approval to challenge Nevro for back pain market

The label expansion comes 16 months after Nevro won FDA approval in non-surgical refractory back pain and four months after Boston Scientific released data on its rival device.

By Nick Paul Taylor • Updated May 17, 2023

Philips claims exposure to foam particles in recalled sleep apnea devices unlikely to harm patients

Inhaling foam particles or chemicals from the recalled devices is unlikely to significantly harm patients, Philips argued, but it added that regulators may reach a different conclusion.

By Elise Reuter • Updated May 16, 2023

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Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

Intuitive Surgical promotes Dave Rosa to president, Guthart remains CEO

The surgical robot maker said longtime CEO Gary Guthart retains his role and will continue to lead the company.

By Susan Kelly • May 16, 2023

Cook Medical lays off 500 after ‘significant change’ to operating environment

In a memo to employees, CEO Pete Yonkman said that hourly manufacturing and distribution workers won’t be laid off because demand for Cook Medical’s products “continues to grow.”

By Nick Paul Taylor • May 16, 2023

Diabetes app developers must generate more data on clinical effectiveness, study says

The researchers saw a need for more data on the wider clinical effectiveness of apps in the management of Type 1 diabetes and prediabetes.

By Nick Paul Taylor • May 16, 2023

Embecta joins Tidepool to develop insulin pump, raises Q2 growth outlook

Embecta advanced its pump project by partnering with Tidepool, a nonprofit that has developed diabetes management software that can work across different brands of pumps and monitors.

By Nick Paul Taylor • May 15, 2023

GE HealthCare’s order book raises questions about sales-growth potential, analysts say

BTIG analysts found “lower order growth than what is assumed” and shared concern the medtech company may face challenges just four months after it was spun off from parent General Electric.

By Nick Paul Taylor • May 12, 2023

AdvaMed cites EPA’s own impact assessment to push back against ethylene oxide proposals

Medtech firms and environmental regulators are at loggerheads as the industry looks for a safe and cost-effective alternative to ethylene oxide for sterilizing reusable devices.

By Nick Paul Taylor • May 12, 2023

Icahn wins proxy firm nod to oust CEO from Illumina board

The recommendation from Glass Lewis is a boost for Icahn’s plan to force change at the DNA sequencer, as he and Illumina’s management battle for proxies ahead of a shareholder vote on May 25.

By Elise Reuter • May 11, 2023

Google adds image analysis capabilities to generative AI model, enabling dialogues with doctors

The Med-PaLM 2 has the ability to review X-rays and mammograms, write reports about images and respond to follow-up questions from caregivers.

By Nick Paul Taylor • May 11, 2023

NuVasive grows sales in Q1, allaying concerns about impact of $3.1B Globus merger

The growth reflects “increased procedure volumes” and a “continued surge in demand” for NuVasive devices.

By Nick Paul Taylor • May 11, 2023

Guardant blood test detects 83% of colorectal cancer cases, but fewer in early stage

Analysts said the test is likely to meet the bar for FDA approval, but its flaws in detecting early-stage cancer weaken its chances against Exact Sciences’ stool-based test, Cologuard.

By Elise Reuter • May 10, 2023

Philips loses vote as shareholders push back against handling of respirator recall

The vote will allow investors to sue board members over their actions in 2022. Philips blamed the ballot loss on guidance from proxy advisors.

By Nick Paul Taylor • May 10, 2023

New breast cancer screening guidelines could boost mammography sales

Hologic, which makes mammography machines, could see an increase in its installed base, according to Needham analysts.

By Elise Reuter • May 9, 2023

GE HealthCare poaches Baxter’s CFO

Jay Saccaro leaves Baxter after eight years as CFO; Helmut Zodl remains at GEHC to run special projects.

By Elise Reuter • May 9, 2023

Baxter, GE HealthCare, Philips are at risk from changes in hospital spending: Moody’s

Volatility in equipment orders from hospital customers will probably continue for at least the next 12 to 18 months, the analysts said.

By Nick Paul Taylor • May 9, 2023

FDA calls for ‘nimble’ regulation of ChatGPT-like models to avoid being ‘swept up quickly’ by tech

The head of the agency said the models are “ushering in the revolution that many of us were hoping for,” but cautioned that the sector will need to be regulated appropriately.

By Nick Paul Taylor • May 9, 2023

Friday Q&A: Boston Scientific’s De Rosa on the rise of an AFib ‘game changer’

The Switzerland-based vice president of rhythm management for Europe, the Middle East and Africa expects a “massive shift” to pulsed field ablation from other atrial fibrillation treatments.

By Susan Kelly • May 5, 2023

Boston Scientific gets DOJ subpoena for documents related to heart monitoring

The disclosure comes as cardiac monitoring device maker iRhythm also said it received a request from the Justice Department.

By Susan Kelly • May 5, 2023

ZimVie will lay off 5% of staff in bid to reduce costs, streamline business

The restructuring, along with reductions in discretionary spending, are expected to save the company $17 million to $20 million by 2024.

By Elise Reuter • May 5, 2023

iRhythm says it received DOJ subpoena regarding company’s ‘products and services’

The company’s shares fell more than 5% after the federal government requested documents.

By Nick Paul Taylor • May 5, 2023

BD raises full-year forecasts again, expects Alaris infusion pump approval

The company said revenue increases in a number of its product lines were faster than market growth rates, suggesting it’s gaining share.

By Susan Kelly • May 4, 2023

Akili shares rise after early data shows video game treatment can improve attention in adults

The company aims to expand its video game-based treatment for ADHD to adults and adolescents. 

By Elise Reuter • May 4, 2023

FDA posts draft guidance on studying medical devices in decentralized clinical trials

Analysts at Cowen said the draft could reassure sponsors they can run decentralized trials without complicating approvals.

By Nick Paul Taylor • May 4, 2023

Tandem expects to meet ‘key’ goals even as rival’s device launch may curb short-term sales growth

Tandem claims it has a better insulin pump than Medtronic’s recently approved rival MiniMed 780G device.

By Nick Paul Taylor • May 4, 2023