The Latest
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Dr. Oz sworn in as CMS administrator
During a ceremony at the Oval Office, Mehmet Oz said he would focus on reducing chronic disease, “modernizing” Medicare and Medicaid, and targeting fraud, waste and abuse in government insurance offerings.
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Medtronic gets FDA approval to use Simplera Sync glucose sensor with insulin pumps
The updated device allows users to pair the sensor with Medtronic’s insulin pumps, and is expected to grow the company’s diabetes business.
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Precision Neuroscience receives FDA clearance for brain implant
The electrode array, which can be implanted for 30 days to map brain activity, is a component of Precision Neuroscience’s planned brain-computer interface system.
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Intuitive, Boston Scientific and Edwards next up in medtech earnings
Tariff talk will continue in the second week of earnings season, but the updates could also shed light on trends and competitive dynamics in key markets.
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FDA cuts outlined in draft HHS budget
The draft budget would slash FDA’s budget authority, if approved by Congress.
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Makary seeks to limit industry’s role in FDA advisory panels
Commissioner Martin Makary said the agency would, whenever possible, restrict drug company employees from participating as industry representatives on advisory committees.
Updated April 18, 2025 -
Retrieved from Ceribell on April 17, 2025
Ceribell wins FDA nod for algorithm to detect pediatric seizures
The clearance adds another feature for Ceribell to leverage as it tries to persuade hospitals to switch from conventional EEG systems.
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Illinois, Minnesota join FTC challenge against $627M Surmodics buyout
The Illinois attorney general said the deal represents a “troubling trend of wealthy investors attempting to limit competition and innovation.”
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Illumina, Tempus AI partner to drive genomic testing beyond cancer
The partners plan to build evidence packages that standardize comprehensive genomic profiling and other molecular testing across all major diseases.
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Budget draft outlines Trump’s plan to slash federal health programs
An OMB document proposes to cut the HHS budget by roughly one-third as well as eliminate several divisions and programs.
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Deep Dive
A judge blocked the FDA’s plan to regulate LDTs. What now?
One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but Congress could still take on the issue.
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Abbott expects a ‘few hundred million’ in tariff costs in 2025
CEO Robert Ford told investors the company had considered raising its earnings forecast for 2025, but decided to maintain it in light of the new tariffs.
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J&J’s electrophysiology sales dip amid slow Varipulse start
Johnson & Johnson’s electrophysiology unit struggled in the first quarter, as the company chases Medtronic and Boston Scientific in the red-hot pulsed field ablation market.
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DaVita hit by ransomware attack
The kidney dialysis firm doesn’t have an estimate for how long disruption from the attack will last, though DaVita stressed it’s continuing to provide patient care.
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Trump tariffs
J&J expects tariff charge of $400M this year
CFO Joe Wolk, who revealed the figure Tuesday morning on CNBC, told investors the charge was primarily in the healthcare giant’s medtech business.
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Edwards receives CE mark for Sapien M3 mitral valve replacement device
The replacement system is launching into markets already served by repair devices, namely Edwards’ Pascal and Abbott’s Mitraclip.
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Trump tariffs
US launches probe that could set stage for pharma tariffs
The Commerce Department has begun a so-called Section 232 investigation into the national security effects of the U.S. importing pharmaceuticals and their starting materials.
Updated April 14, 2025 -
Trump tariffs
US launches probe into semiconductor imports
The Section 232 investigation comes ahead of anticipated tariffs on the industry.
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J&J completes first surgeries with Ottava robot
Johnson & Johnson plans to seek a U.S. indication for multiple general surgery procedures, including gastric bypass, which was performed in the clinical trial.
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Trump tariffs
Tariffs top of mind for medtech firms this earnings season
GE Healthcare and Medtronic said they are preparing mitigation plans as they assess the potential ramifications of Trump’s tariff policies.
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The image by Coolcaesar is licensed under CC BY-SA 4.0
Cepheid to lay off 167 people in California
The company laid off more than 1,300 people in California in 2023 and 2024 as respiratory sales fell from the peak hit during the pandemic.
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Trump tariffs
Pharma bosses face down investor angst on tariffs, HHS chaos
As first quarter earnings begin, executives are confronting market turmoil, regulatory instability and the threat of U.S. tariffs on their products.
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Late-stage digital health funding rebounds in Q1: Rock Health
The median deal size for late-stage funding rounds was $105 million, nearly double the $55 million check size across 2024.
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Retrieved from Intuitive Surgical on April 11, 2025
Intuitive wins FDA clearance for single-port robotic surgery stapler
CFO Jamie Samath said in January that the stapler clearance would trigger the start of “broad commercial efforts” for the single-port system.
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Trump tariffs
Tariff turmoil: Hospitals, device makers welcome pause, but fear long-term pain
Healthcare providers and medtech companies still face pressure to find ways to offset potential supply chain shocks despite the latest about-face in President Donald Trump’s tariff wars.