The Latest
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Courtesy of iRhythm
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.”
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Courtesy of Penn State University/Huanyu “Larry” Cheng
Low-cost, disposable ‘pencil-on-paper’ sensor opens population health opportunities
Designed by the research team that developed the smart diaper, the paper patch could be used to detect cardiopulmonary disease and treat inflammation, or monitor disease outbreaks.
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Illumina appeals FTC’s order to divest Grail with plea for cancer screening test
The DNA-sequencing company that has been fighting regulators over orders to reverse its 2021 acquisition of Grail is accusing the U.S. government of overreach and collusion with European regulators.
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Courtesy of Philips
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.
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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.
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Courtesy of Abiomed/J&J
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.
Updated June 5, 2023 -
Courtesy of Grail
Grail blames vendor glitch for patient notifications of incorrect cancer diagnosis
The erroneous letters from telemedicine provider PWNHealth come as Grail’s parent company, Illumina, is facing pressure from regulators and shareholders to divest the liquid biopsy maker.
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Joe Raedle via Getty Images
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.
Updated June 6, 2023 -
Permission granted by Politan Capital Management
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.
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Courtesy of Cue Health Press Kit
Cue Health’s inability to find post-COVID markets for testing prompts Goldman downgrade
The analysts warned switching to non-COVID-19 tests will mean entering a competitive market “where larger companies with financial resources have an established installed base.”
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Permission granted by Medtronic
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.
Updated June 5, 2023 -
N/A via Getty Images
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.
Updated June 2, 2023 -
Courtesy of Illumina
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.
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Provided by ArcBest
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.
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curioustiger via Getty Images
Illumina trains AI on primate data to estimate risk of rare variants in humans
The results suggest AI can help improve genetic risk prediction for healthy humans, which could boost demand for Illumina’s gene sequencing devices.
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Permission granted by Becton Dickinson
BD names Laura Boros president of pharmaceutical systems
The appointment fills the vacancy at the top of the small but fast-growing division.
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Permission granted by iRhythm
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.
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Retrieved from Medtronic on June 01, 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.
Updated June 1, 2023 -
Courtesy of Penumbra
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.
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Retrieved from Masimo on June 01, 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.
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Courtesy of High Purity New England
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.
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deliormanli via Getty Images
Patient advocacy groups urge FDA to regulate lab-developed tests if VALID Act doesn’t pass
Legislation has been proposed in Congress to bring diagnostic tests under a single regulatory framework, but if it doesn’t pass, the FDA has authority to regulate lab-developed tests, the groups said.
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titoOnz via Getty Images
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.
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D-Keine via Getty Images
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.
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Retrieved from SD Biosensor / FDA on May 30, 2023
Recall of Roche partner’s COVID tests labeled as Class I
The at-home COVID tests, made by SD Biosensor and distributed by Roche, were recalled for bacterial contamination.
Updated 13 hours ago
