Boston Scientific pulls forward expected approval for Farapulse PFA system

Analysts said a first quarter approval would increase their confidence in the company’s potential for sales growth of 10% or more.

By Nick Paul Taylor • Jan. 3, 2024

Roche to buy LumiraDx’s point-of-care technology for $295M

LumiraDx faces financial pressures amid declining test sales and a potential delisting from the Nasdaq.

By Elise Reuter • Jan. 2, 2024

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

Philips recalls MRI machines due to risk of explosion

The Food and Drug Administration labeled the recall as a Class I event. There has been one report of a machine exploding in the 22 years the system has been in use.

By Nick Paul Taylor • Dec. 22, 2023

Agilent to lay off about 400 workers amid site closures

Most of the reductions, which equal about 2% of the company’s global workforce, will be completed in the first quarter, Agilent said.

By Susan Kelly • Dec. 22, 2023

Resmed posts notice about risk of mask magnets interfering with medical implants

Like its rival Philips, Resmed has determined that patients should not wear magnetized masks near some implants.

By Nick Paul Taylor • Dec. 22, 2023

SEC charges former Stimwave CEO with $41M fraud scheme

The Securities and Exchange Commission alleges that Laura Tyler Perryman approved the creation of “fake” implantable parts for the company’s PNS device and defrauded investors of $41 million.

By Ricky Zipp • Dec. 21, 2023

Apple to pause US sales of smartwatches with pulse oximetry

The tech giant’s move follows a USITC ruling that found the watches infringed some of Masimo's patents for measuring blood oxygen.

By Susan Kelly • Dec. 20, 2023

FDA drafts guidance outlining real-world evidence for medical device submissions

By issuing the new guidance, the agency is meeting the requirements of a year-end spending bill.

By Elise Reuter • Dec. 19, 2023

Zimvie to sell spine business for $375M

Zimvie said the sale to H.I.G. Capital will leave the company focused on its dental business and help reduce debt.

By Elise Reuter • Dec. 18, 2023

BTIG analysts optimistic medtech will rebound in 2024 after ‘string of rough years’

Rising interest rates, fears about the impact of GLP-1 drugs and “choppy supply-chain dynamics” dragged on the industry this year, the analysts wrote.

By Nick Paul Taylor • Dec. 18, 2023

Glaukos wins FDA approval for drug-releasing eye implant to treat glaucoma

William Blair analysts said the product “should revolutionize how glaucoma is treated by addressing noncompliance with drops.”

By Nick Paul Taylor • Dec. 15, 2023

Tandem completes US launch of revamped diabetes management platform

The platform, Tandem Source, combines the features of the company’s legacy t:connect offerings with new data reports.

By Nick Paul Taylor • Dec. 15, 2023

Medtronic snags first pulsed field ablation approval in US

The treatment for atrial fibrillation has gained attention as a safer alternative to radiofrequency and cryoablation. Boston Scientific and Johnson & Johnson are also pursuing the PFA market.

By Susan Kelly • Dec. 14, 2023

Resmed hails ‘significant victory’ as patent board rules in dispute with NYU

The decisions invalidate claims that NYU argued were infringed by Resmed’s sleep apnea devices.

By Nick Paul Taylor • Dec. 14, 2023

In wake of Philips recall, senators urge review of FDA medical device oversight

Sens. Richard Durbin and Richard Blumenthal said the sleep apnea device maker “did nothing” while patients suffered.

By Susan Kelly • Dec. 14, 2023

Integra to buy J&J’s Acclarent for $275M

Integra said the purchase, which includes a portfolio of balloon dilation products for the sinuses and eustachian tube, would make it a market leader in ENT procedures.

By Elise Reuter • Dec. 13, 2023

Zimvie’s collaboration with Brainlab delivers 510(k) win for spinal fixation system

Amid recent struggles in its spine unit, Zimvie has been expanding its Brainlab partnership.

By Nick Paul Taylor • Dec. 13, 2023

The FDA approved 2 renal denervation devices. There are still questions about who will benefit.

The devices from Recor and Medtronic are intended to treat high blood pressure. An advisory panel backed the former, but recommended against approval of the latter.

By Elise Reuter • Dec. 13, 2023

Activist investor takes stake in Nevro amid struggles to grow neuromodulation sales

Engaged Capital is opposed to Nevro going after acquisitions that may jeopardize its core business, Bloomberg reported Monday.

By Nick Paul Taylor • Dec. 12, 2023

Why heart device makers are investing in left atrial appendage closure

Medtronic and Johnson & Johnson are pursuing a market that leader Boston Scientific predicts could hit $6 billion by 2030.

By Susan Kelly • Dec. 12, 2023

Hologic promotes Essex Mitchell to COO

Mitchell joined Hologic as vice president of sales and commercial excellence for the GYN surgical division in 2017.

By Nick Paul Taylor • Dec. 11, 2023

Medtronic expands AI endoscopy partnership with Cosmo

The collaboration will focus on Cosmo Intelligent Medical Devices’ GI Genius module, which Medtronic distributes globally.

By Elise Reuter • Dec. 11, 2023

Advamed adds medical imaging division, names new board chair

The medtech association is bringing on staff from the Medical Imaging & Technology Alliance to lead the new division.

By Elise Reuter • Dec. 11, 2023

BD receives 510(k) clearance for fingerstick blood test sample collection device

The clearance positions BD and partner Babson Diagnostics to support blood collection from community sites such as pharmacies.

By Nick Paul Taylor • Dec. 8, 2023

Medtronic secures CE mark for rechargeable Percept deep brain stimulation device

The company plans to make the device available in Western Europe this month and “launch in additional regions based on local regulations.”

By Nick Paul Taylor • Updated Dec. 13, 2023