EPA’s proposed ethylene oxide regulations may cost sterilizers more than estimated: Moody’s

Large commercial sterilizers should be able to handle the increased costs, but smaller companies might have to sell, Moody’s analysts write. 

By Elise Reuter • June 9, 2023

Friday Q&A: Biosense Webster’s Brooks and Hong talk about cardiac ablation

The leaders of Johnson & Johnson’s Biosense Webster unit see growth opportunities with new cardiac ablation technologies, despite a crowded field that includes Abbott, Boston Scientific and Medtronic.

By Elise Reuter • June 9, 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

SunMed agrees to $110M takeover of Avanos’ respiratory health unit, continuing M&A spree

Avanos, whose competitors include Stryker and Medline Industries, is selling the unit to narrow its focus on areas where it can succeed.

By Nick Paul Taylor • June 9, 2023

New devices could help Penumbra take market share, according to physician survey

Penumbra’s new systems for removing blood clots from veins and arteries received a positive reception, with doctors expecting to use the company’s devices more, according to a survey of 25 surgeons by J.P. Morgan. 

By Elise Reuter • June 8, 2023

In shift away from toxic ethylene oxide, Colorado firm offers ‘green’ chlorine dioxide sterilization

The addition of chlorine dioxide capabilities comes as the industry races to find alternatives to ethylene oxide ahead of restrictions on the use of the carcinogenic gas.

By Nick Paul Taylor • June 8, 2023

Precision Neuroscience’s brain implant maps electrical activity in a first-in-human trial

Created by a founder of Elon Musk’s Neuralink, Precision has developed a device with some 1,000 electrodes in a one square centimeter flexible film. The trial could open the way to a computer-brain interface.

By Nick Paul Taylor • June 8, 2023

Cue Health wins first non-emergency authorization for COVID test, days after Goldman downgrade

The FDA’s marketing authorization for Cue’s COVID-19 molecular test could boost consumer access, but the company faces strong competition from more established diagnostic firms.

By Peter Green • June 7, 2023

Teleflex prevails in Medtronic’s appeal over guide catheter patents

A federal appeals court judge denied Medtronic’s claims that Teleflex’s catheters were unpatentable.

By Elise Reuter • Updated June 7, 2023

How they built it: Florian Hillen wants to look at your teeth with his AI

Hillen is building a business on the premise that using artificial intelligence to examine dental X-rays can nearly double diagnostic accuracy, and help detect other diseases.

By Peter Green • June 7, 2023

FDA: iRhythm targeted heart monitor at ‘high-risk’ patients without seeking clearance

William Blair analysts believe “customers are unlikely to change their usage of Zio AT [heart monitors] over time, making this a resolvable issue.”

By Nick Paul Taylor • June 7, 2023

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

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