The Latest
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CDRH Director Shuren to step down after 15 years
Michelle Tarver, deputy director for transformation, will serve as acting director of the FDA’s medical devices unit.
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Boston Scientific tips strong growth for Farapulse after successful launch
Questions on Boston Scientific’s pulsed field ablation system once again dominated the company’s earnings call.
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Top 5 medtech deals in the first half of 2024
The first six months of the year brought a series of multibillion-dollar deals, led by Johnson & Johnson’s $13.1 billion takeover of Shockwave Medical.
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Cook Medical to sell reproductive health business to private equity firm
Astorg intends to combine the Cook assets with Hamilton Thorne, another reproductive health business it plans to buy.
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Retrieved from ICU Medical on July 23, 2024
ICU Medical to close Minnesota facility, cut 83 jobs
The infusion pump maker has focused on consolidating service centers and manufacturing sites since it bought Smiths Medical in 2022.
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Guardant settles allegations it violated the False Claims Act
The settlement resolves claims that an oncologist ordered significantly more tests after Guardant hired two people the physician recommended for jobs at the company.
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Q&A
‘Our next frontier is prediction’: Medtronic on AI and heart disease
Stacey Churchwell, who leads the company’s cardiovascular diagnostics and services business, says artificial intelligence is reducing false positives in its insertable cardiac monitors, saving clinicians valuable time.
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Diabetes device firm Embecta considers sale: Financial Times
Two years after Embecta spun out of BD, the firm is now exploring a potential sale, the Financial Times reported.
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FDA sends 2 warning letters after inspecting Chinese syringe manufacturers
One warning letter covers the production of plastic syringes for Cardinal Health.
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Truvian raises $74M to bring blood test instrument to market
The device is designed to perform the most commonly ordered blood tests, avoiding the need to send the samples to central labs.
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Intuitive’s da Vinci 5 robot launch ‘well ahead’ of Wall Street expectations
Early customer feedback on the new robot suggests features such as improved ergonomics and vision technology are helping drive adoption, executives said.
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GE Healthcare to buy AI software from Intelligent Ultrasound for $51M
After purchasing Caption Health last year, GE Healthcare plans to add another artificial intelligence acquisition to the company.
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Dental implant maker Osstem in talks to acquire Zimvie: report
Bloomberg first reported M&A rumors in June when Zimvie was approached about a takeover.
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CrowdStrike outage hits US hospitals
The cybersecurity firm released what was meant to be a routine software update, but now health systems, including CommonSpirit Health and Cleveland Clinic, are locked out of Windows systems.
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Deep Dive
Medtech firms have cut more than 14,000 jobs in the past 18 months
Diagnostics is the largest industry represented in the data, with more than 5,000 affected positions, according to MedTech Dive’s analysis.
Updated July 25, 2024 -
Abbott previews PFA, over-the-counter CGM markets
Electrophysiology sales held up against rivals’ launches of pulsed field ablation systems. Meanwhile, Abbott is gauging sales of its first OTC CGMs.
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Danaher setting up labs to support companion diagnostic development
Danaher plans to open a U.K. laboratory this month, followed by a second facility in the U.S. later this year.
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Qiagen to cut 175 employees, close Michigan PCR test plant
The layoffs and plant closure are part of a restructuring plan that Qiagen estimates will cost about $400 million.
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J&J medtech fails to meet growth expectations
CFO Joe Wolk told investors Wednesday that Johnson & Johnson’s medical device business missed the company’s 5%-7% growth forecast in the second quarter.
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Quest closing Pennsylvania lab, laying off 121 people
Quest is consolidating drug testing at a facility in Kansas, but will keep rapid response, pathology and IT staff at the Norristown site.
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J&J, Abbott and Intuitive start medtech earnings season
The companies’ financial results will offer a glimpse at the current health of medtech markets.
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Masimo sues activist investor Politan, postpones annual meeting
The latest turn in the recent drama comes days after proxy advisory firms ISS and Glass Lewis backed two Politan nominees for Masimo’s board.
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FDA creates communication ‘super office’ at CDRH
The changes are part of a broader reorganization intended to increase organizational agility and help the agency meet user fee commitments.
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Edwards to acquire Innovalve, stake in Affluent Medical
The heart valve specialist said in a federal filing that it expects to pay $300 million in cash for Innovalve Bio Medical when the deal closes.
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House committee tells FDA to suspend lab developed test rule
Lawmakers said the final rule carries “the risk of greatly altering the United States’ laboratory testing infrastructure.”