Medical Devices
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Tariffs send healthcare industry into ‘unchartered waters’
Provider groups and health systems warn tariffs will test healthcare’s fragile supply chain, and Wall Street said medtech businesses will face pressure, particularly diabetes tech firms.
By Susanna Vogel , Susan Kelly • April 4, 2025 -
China readies 34% tariff on US imports starting April 10
The country’s retaliation against President Donald Trump’s trade policies builds upon previously announced duties.
By Max Garland • April 4, 2025 -
Explore the Trendline➔
Sitthiphong via Getty ImagesTrendlineMedical 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 -
Eargo, Hearx merge into one OTC hearing aid firm, receive $100M boost
Hearx, the maker of Lexie hearing aids, and Eargo competed for the OTC hearing aid market created by the FDA in 2022.
By Nick Paul Taylor • April 3, 2025 -
Dr. Oz confirmed to lead CMS
Dr. Mehmet Oz, a physician and TV personality, will lead the agency during a turbulent time for federal health programs as the HHS lays off thousands of staffers and Republicans float potential cuts to Medicaid.
By Emily Olsen • Updated 11 hours ago -
Trump tariffs
AdvaMed repeats call for tariff exemption as new levies threaten healthcare supply chain
Lobby groups like AdvaMed and the American Hospital Association have so far failed to get medical devices and critical supplies carved out from the Trump administration’s tariffs.
By Susan Kelly , Susanna Vogel • April 3, 2025 -
Boston Scientific’s Farapulse matches Medtronic cryoablation in trial
Atrial tachyarrhythmia recurred in 39 patients treated with Boston Scientific’s Farapulse PFA device, while 53 people had recurrence in the Medtronic cryoablation group.
By Nick Paul Taylor • April 3, 2025 -
Trump tariffs
Trump installs 10% baseline tariff, country-specific duties
The president said he will levy import taxes on China, Japan and others equal to half of what they charge the U.S. based on White House calculations.
By Philip Neuffer • April 3, 2025 -
CMR Surgical secures $200M for US robot rollout
Launching Versius in the U.S. is a top priority for CMR, which claims the system is the second most adopted soft tissue robot globally.
By Susan Kelly • April 2, 2025 -
HHS overhaul
‘Just goodbyes and crying’: CDRH hit in HHS mass layoffs
Teams working on communications and policy were cut from the agency on Tuesday, according to multiple FDA workers interviewed by MedTech Dive.
By Elise Reuter • April 2, 2025 -
3 takeaways from ACC 2025
Medtronic, Abbott and Boston Scientific had updates on their devices used in heart valve disease treatment at the event.
By Susan Kelly • April 2, 2025 -
Texas judge overturns FDA’s lab developed test regulation, siding with industry groups
The judge vacated the FDA’s final rule, which was strongly opposed by the laboratory industry, and remanded the matter to HHS Secretary Robert F. Kennedy Jr.
By Susan Kelly • April 1, 2025 -
Bausch + Lomb recalls Envista intraocular lenses over safety risks
J.P. Morgan analysts said it was too early to discuss the financial impact of the recall, but estimated that $70 million to $90 million of revenue could be at risk this year.
By Nick Paul Taylor • March 31, 2025 -
Tandem eyes Medicare coverage expansion for Type 2
CMO Jordan Pinsker said Tandem hopes to expand Medicare coverage of its automated insulin delivery systems using new data shared at ATTD.
By Elise Reuter • March 31, 2025 -
J&J launches energy generator compatible with Ottava robot
Johnson & Johnson said the Dualto energy system’s design allows for up to 46% less footprint than separate generators.
By Nick Paul Taylor • March 28, 2025 -
HHS overhaul
‘Everything is word of mouth’: HHS employees face uncertainty in looming Trump layoffs
Many HHS department heads and employees were unaware of plans to fire some 10,000 employees until they were announced Thursday, sources said.
By Sydney Halleman , Ned Pagliarulo , Rebecca Pifer • March 28, 2025 -
Abbott snags early CE mark for Volt PFA device
With PFA becoming physicians’ preferred ablation method for treating AFib, Abbott is pushing to catch up with rival systems already on the market.
By Susan Kelly • March 28, 2025 -
Newly public Beta Bionics reports sales surge; Dexcom hires CCO
Sales of Beta Bionics insulin pumps spiked 145% in the fourth quarter behind solid new patient starts. Elsewhere, former Masimo exec Jon Coleman joined Dexcom, and Sibionics’ CGM earned the CE mark.
By Nick Paul Taylor • March 28, 2025 -
Dexcom rejects claims of unauthorized device changes in FDA warning letter
A company spokesperson said Dexcom plans to resolve the agency’s concerns but stated no design changes were made to its glucose sensors.
By Elise Reuter • March 27, 2025 -
HHS overhaul
HHS to cut 10,000 employees in major restructuring under RFK Jr.
Advamed CEO Scott Whitaker said Thursday that “any reduction in force should be accompanied by policy and regulatory improvements that encourage innovation in medtech.”
By Ned Pagliarulo , Rebecca Pifer , Ricky Zipp • Updated March 27, 2025 -
Solventum cuts 800 positions
CEO Bryan Hanson told investors last week that the restructuring plan would save Solventum $120 million annually.
By Ricky Zipp • March 26, 2025 -
Senate committee advances Dr. Oz to lead CMS
Democrats on the Senate Finance Committee criticized the physician and TV personality ahead of the vote Tuesday for avoiding questions about potential cuts to Medicaid.
By Emily Olsen • March 26, 2025 -
Dexcom’s FDA warning letter reveals unauthorized changes to sensors
Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, according to the warning letter.
By Elise Reuter • March 26, 2025 -
Q&A
Dexcom COO on 15-day glucose sensor, Type 2 coverage
Jake Leach caught up with MedTech Dive during the ATTD conference to discuss new data on the company’s glucose monitors and an FDA warning letter.
By Elise Reuter • March 25, 2025 -
Deep Dive
5 tips for building a predetermined change control plan
The new framework is intended to make postmarket changes easier for products. Experts recommend having a clear roadmap and contacting regulators early.
By Elise Reuter • March 25, 2025 -
Abbott gets FDA nod to begin IVL trial after rivals buy up competition
J&J acquired the IVL device maker Shockwave Medical last year for $13.1 billion, and Boston Scientific agreed to buy Bolt Medical in January for up to $664 million.
By Nick Paul Taylor • March 25, 2025