Medical Devices: Page 2
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Apreo raises $130M for pivotal trial of emphysema device
The company, which received investment from the venture capital wing of Intuitive Surgical, has designed the device to work in a broader patient population than existing treatments.
By Nick Paul Taylor • Aug. 11, 2025 -
Tandem, Insulet monitoring CMS payment proposal for diabetes tech
The proposal would introduce competitive bidding for insulin pumps and change how Medicare pays for diabetes devices, if finalized.
By Elise Reuter • Aug. 8, 2025 -
Explore the Trendline➔
Sara Silbiger via Getty ImagesTrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Masimo appoints several senior execs, resolves cyber incident
The pulse oximeter maker is now fully operational after a spring cyberattack and increased its 2025 profit forecast, but investors have raised questions about the status of a partnership with Philips.
By Susan Kelly • Aug. 8, 2025 -
Boston Scientific updates instructions of devices linked to 17 deaths
The update covers devices used in procedures to implant the company’s Watchman heart device.
By Nick Paul Taylor • Aug. 8, 2025 -
Boston Scientific tells users about defibrillator problem linked to deaths, injuries
A company spokesperson said in a statement to MedTech Dive that direct causation between the deaths and calcification of the leads cannot be assumed or confirmed.
By Nick Paul Taylor • Aug. 7, 2025 -
Tandem insulin pump malfunction linked to 59 injuries
A problem with speakers in Tandem’s t:slim X2 insulin pumps can cause insulin delivery to stop, the company said.
By Elise Reuter • Aug. 7, 2025 -
Trump plans 100% tariffs for semiconductor imports
Chips are one of several product types currently under Section 232 investigation by the White House, a frequent precursor to duties.
By Philip Neuffer • Aug. 7, 2025 -
BD commits $35M to expand US syringe production plant
The company said it has grown capacity by 10% this year, bringing its total U.S. output of the prefilled flush syringes to above 750 million units.
By Nick Paul Taylor • Aug. 6, 2025 -
FTC moves to block Edwards’ JenaValve acquisition
Edwards Lifesciences and JenaValve said they remained committed to completing the deal and would defend the case in court.
By Susan Kelly • Aug. 6, 2025 -
Medical device industry says future MDUFA hikes unsustainable
Device lobbyists’ priorities contrasted with patient advocates, who sought an increase in user fees and more funds for postmarket safety.
By Elise Reuter • Aug. 5, 2025 -
EU delays countermeasures to US tariffs by 6 months
The bloc has now paused implementation three times, with the latest moratorium coming after reaching a framework deal with the U.S.
By Philip Neuffer • Aug. 5, 2025 -
Philips BiPAP machine recall associated with 8 deaths
Philips sent updated instructions after disclosing problems last year with an alarm that can interrupt treatment for people with obstructive sleep apnea or respiratory insufficiency.
By Elise Reuter • Aug. 5, 2025 -
Alcon to acquire STAAR Surgical for about $1.5B
BTIG analyst Ryan Zimmerman called the transaction “a solid deal” for Alcon given STAAR’s struggles in the China market.
By Susan Kelly • Aug. 5, 2025 -
First Corcym aortic valve implanted via new robotic procedure
CEO Christian Mazzi said the minimally invasive surgical technique could provide better outcomes for patients than transcatheter aortic valve replacement.
By Susan Kelly • Aug. 5, 2025 -
Heartflow prices IPO, aiming to net about $180M
The company, which sells software for creating 3D heart models, plans to offer 12.5 million shares at a range of $15 to $17 per share.
By Nick Paul Taylor • Aug. 4, 2025 -
Vicarious Surgical names Stephen From as next CEO
From, who joins the surgical robot developer from Aruna Bio, will take the reins from co-founder Adam Sachs on Aug. 7.
By Susan Kelly • Aug. 1, 2025 -
Trump tariffs
US, Mexico agree to extend USMCA-tariff pause
The two countries will continue to negotiate over a 90-day period during which imports from Mexico will avoid a planned 30% tariff from the Trump administration.
By Philip Neuffer • Aug. 1, 2025 -
News roundup
Monogram robot marks autonomy milestone; Stereotaxis catheter cleared
Monogram Technologies conducted its first fully autonomous robotic knee replacement surgery, while Stereotaxis won FDA clearance for a robotically navigated electrophysiology mapping catheter.
By Susan Kelly • July 31, 2025 -
Dexcom raises sales expectations, discusses G8 plans
Outgoing CEO Kevin Sayer expects expanding coverage of Dexcom’s glucose sensors for people with Type 2 diabetes and over-the-counter devices to drive future growth.
By Elise Reuter • July 31, 2025 -
Cardiosense wins FDA clearance for wearable heart monitor
The device captures various types of heart data that could be used in AI models for cardiovascular parameters with the aim of lowering barriers to monitoring.
By Nick Paul Taylor • July 31, 2025 -
Dexcom CEO Kevin Sayer to step down
Jake Leach will take over the role at the start of 2026, with Sayer remaining chairman of the board after the transition.
By Elise Reuter • Updated July 31, 2025 -
Earnings & Tariffs
GE HealthCare projects reduced tariff expense
Executives also said demand for capital equipment continues to be healthy. However, investors may have expected stronger order growth.
By Susan Kelly • July 30, 2025 -
Earnings & Tariffs
Siemens Healthineers cuts tariff impact after trade talk breakthrough
The company predicted a full-year impact of 200 million to 250 million euros, down from its previous forecast of up to 300 million euros.
By Nick Paul Taylor • July 30, 2025 -
Earnings & Tariffs
Philips lowers expected tariff hit to 150M to 200M euros
The company previously forecast an up to 300 million euro tariff impact in 2025 before the U.S. struck agreements with China and the European Union.
By Elise Reuter • July 29, 2025 -
J&J’s Ethicon recalls stapler cartridges over issue linked to 1 death
The FDA said the device can lock, leading to adverse events including surgical delay, bleeding and death.
By Nick Paul Taylor • Updated July 29, 2025