Philips faces new recall of Evo respirators, tagged Class I by FDA

The woes are continuing for Philips and its Respironics unit, whose ventilators and other breathing assist devices have faced a slew of recalls. 

By Peter Green • June 6, 2023

Nevro names new chief commercial officer, cuts forecast as spine stimulation market tightens

While the company’s new chief commercial officer and its recently appointed CEO “have a considerable amount of experience,” Nevro still faces challenges in its core market, according to analysts.

By Elise Reuter • June 6, 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

Abiomed heart pump recall labeled Class I by FDA, no deaths reported

The recall, tied to specific sets of the Impella 5.5 with SmartAssist, comes just months after Johnson & Johnson paid $16.6 billion for Abiomed.

By Peter Green • Updated June 5, 2023

Medtronic names former Amazon robotics VP as technology chief

Ken Washington, who has also served as chief technology officer at Ford and Lockheed Martin, will be charged with driving growth through innovation at the world’s largest medical device maker by revenue.

By Susan Kelly • Updated June 5, 2023

Novo Nordisk says in talks to acquire French device-maker Biocorp for $165M

The offer per share is about 20% more than Biocorp’s closing stock price on June 2. The two companies plan to focus on drug delivery solutions for chronic diseases, such as diabetes.

By Elise Reuter • Updated June 6, 2023

Masimo board accepts appointment of activist investor’s nominee, with caveats

The agreement to let former J&J executive Michelle Brennan join its board comes as Masimo, and founder and CEO Joe Kiani, are working to fend off activist investor Quentin Koffey.

By Nick Paul Taylor • June 5, 2023

Geographic disparities in the rise of orthopaedic ASCs

The shift towards orthopaedic procedures at ASCs is growing, but growth has been inconsistent across the US. AcuityMD shares the geographies poised for ASC growth.

By Michael Monovoukas, CEO, Co-Founder, AcuityMD • June 5, 2023

Deaths reported with Philips ventilators, sleep apnea machines still climbing

The FDA reported 40 additional deaths tied to the recall of Philips’ devices in its latest update.

By Susan Kelly • Updated June 2, 2023

AdvaMed lobbies for medtech companies to be prioritized in global supply chain

The medtech trade group published a white paper outlining supply chain improvements needed to ensure availability of materials and parts for medical devices.

By Elise Reuter • June 2, 2023

Illumina adds 2 medtech execs to its board, weakening Icahn’s influence

Hologic CEO Stephen MacMillan and Edwards Lifesciences CFO Scott Ullem join just a week after chair John Thompson was ousted in a proxy battle with Icahn. 

By Susan Kelly • June 2, 2023

BD names Laura Boros president of pharmaceutical systems

The appointment fills the vacancy at the top of the small but fast-growing division.

By Nick Paul Taylor • June 2, 2023

Medtronic’s Brewer jumps to Baxter to lead patient support systems

Julie Brewer spent nearly 17 years at Medtronic, most recently in the role of president of cardiovascular diagnostics and services.

By Susan Kelly • Updated June 1, 2023

Penumbra launches thrombectomy device aimed at reducing surgery, amputation

The system, which includes a built-in algorithm, can remove large, rigid clots in the arteries that often require open surgery.

By Elise Reuter • June 1, 2023

Masimo pushes back against activist investor it argues will cause ‘dysfunction and chaos’

Launching a proxy battle for two board seats, Politan Capital says Masimo is underperforming its peers and making misleading public statements.

By Nick Paul Taylor • June 1, 2023

FDA hits iRhythm with warning letter over problems at heart monitor facility

iRhythm can continue to manufacture and sell its products and does not expect the warning letter to materially affect its financial results.

By Nick Paul Taylor • June 1, 2023

Getinge will acquire High Purity for as much as $370M to bolster biopharma business

The acquisition is aimed at strengthening Getinge’s position in the fast-growing area of custom single-use solutions for bioprocessing applications.

By Peter Green • May 31, 2023

MedTech Europe sets out position on cybersecurity, making case for reliance on MDR

As the number of connected medical devices grows, the industry group argues that Europe’s new medtech regulations should remain “the primary avenue” for medical device cybersecurity.

By Nick Paul Taylor • Updated June 12, 2023

Microrobots powered by ultrasound show progress in drug delivery experiments in mice

Potential applications of the technology include the treatment of painful bladder syndrome, a condition that is currently managed with multiple injections.

By Nick Paul Taylor • May 31, 2023

Titan licenses robotic surgery intellectual property to Intuitive after failing to find buyer

After failing to bring its surgical robot to market and getting kicked off the Nasdaq, Titan is now marketing its intellectual property.

By Nick Paul Taylor • May 30, 2023

Friday Q&A: Stanford Biodesign’s Makower on expediting Medicare coverage for breakthrough devices

The director and co-founder of the Stanford Byers Center for Biodesign has been urging CMS to get patients access to breakthrough devices.

By Susan Kelly • Updated May 26, 2023

Boston Scientific cancels $230M stent deal after regulators erect barriers to acquisition

The Federal Trade Commission said Boston Scientific took the action in response to investigations by its staff and overseas enforcement partners.

By Nick Paul Taylor • May 26, 2023

Abbott’s remote heart failure monitoring system reduces hospitalizations in clinical trial

The study is the third randomized, controlled trial globally to link CardioMEMS to a significant health benefit.

By Nick Paul Taylor • May 26, 2023

Medtronic posts profit, sales growth in Q4, agrees to buy Korean diabetes patch maker

The company is “confident in delivering durable revenue growth in the year ahead” amid continued improvements in procedure volumes.

By Peter Green • May 25, 2023

Slump in medtech VC activity continues as inflation keeps investors on the sidelines

Investors struck deals worth $1.8 billion over the first three months of the year, down from $3.0 billion across the start of 2022.

By Nick Paul Taylor • May 25, 2023

Acurable prepares to challenge ResMed for sleep apnea diagnosis market

The company’s device records the sounds of the patient’s respiratory and cardiac functions and monitors blood oxygen levels to assess suspected obstructive sleep apnea.

By Nick Paul Taylor • May 25, 2023