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BioWorld - Sunday, December 28, 2025
Home » Topics » U.S., BioWorld MedTech

U.S., BioWorld MedTech
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Illustration of ovary, uterus and endometrial cancer.

Acrivon narrows focus for ACR-368 in endometrial cancer

March 27, 2025
By Jennifer Boggs
Acrivon Therapeutics Inc. provided updated phase II data for checkpoint kinase candidate ACR-368, highlighting promising response rates for biomarker-positive patients with endometrial cancer and raising the possibility of an accelerated pathway in the second-line setting.
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Partial view of woman holding paper made intestines over stomach

Uresta raises $3M to stop urinary leaks

March 26, 2025
By Annette Boyle
Resilia Inc., dba Uresta, raised $3 million to launch its device to stop stress urinary incontinence in women. The flexible, insertable device braces the bladder and compresses the urethral passage to reduce or eliminate leakage during exercise, when coughing or laughing or when a woman just doesn’t want to worry about it. BDC Capital led the funding with a $1.5 million investment.
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Bhattacharya-Makary

Senate votes in Makary, Bhattacharya at FDA and NIH

March 26, 2025
By Mark McCarty
The U.S. Senate has approved the nominations of two key members of the Trump administration, Marty Makary as FDA commissioner and Jay Bhattacharya as NIH director. While these are two of the most critical appointments for the Trump administration, the Senate still has two other important appointments in queue, including the directors of the Centers for Medicare & Medicaid Services and the CDC.
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Dexcom G7 CGM

FDA says changes in Dexcom G6, G7 sensors constitute misbranding

March 26, 2025
By Mark McCarty
The U.S. FDA’s March 4, 2025, warning letter to Dexcom Inc. is a well-detailed but heavily redacted document explaining the agency’s misgivings about procedures such as monitoring of acetaminophen content in glucose test dishes.
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OP5_INSU_POD_PDM_NoADH_RIGHT_RGB.jpg

Insulet glows with RADIANT results, CGMs becoming T2D standard

March 25, 2025
By Annette Boyle
For people with type 1 or type 2 diabetes and the companies developing technologies to help them, the International Conference on Advanced Technologies & Treatments for Diabetes delivered an abundance of good news. On the type 1 diabetes front, Insulet Corp.’s RADIANT study demonstrated massive improvement in time in range as well as lower glycemic levels for patients switching from multiple injections to the Omnipod 5 automated insulin delivery system.
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Art concept for antimicrobial research

FDA clears Biomérieux’s Vitek Compact antimicrobial resistance system

March 25, 2025
By Shani Alexander
Biomérieux SA recently received U.S. FDA 510(k) clearance for its Vitek Compact Pro, a system for microorganism identification and Antibiotic Susceptibility Testing. The company hopes that the system will help clinical laboratories combat antimicrobial resistance and diagnose infectious diseases as well as support industrial laboratories in identifying contaminants to ensure consumer safety.
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CMS logo and website

Oz hits Wyden’s wall of skepticism in Senate CMS post hearing

March 25, 2025
By Mark McCarty
Mehmet Oz, the Trump administration’s pick to lead the U.S. Centers for Medicare & Medicaid Services (CMS), appeared for a second time in the Senate for the CMS administrator’s job.
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Product recall concept image

Smith’s Medical removes endotracheal tubes due to small diameter

March 25, 2025
By Mark McCarty
The FDA reported March 25 that Smiths Medical Inc., is recalling a series of oral and nasal endotracheal tubes because the diameters of the tubes may present with “a smaller diameter than expected.”
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Medicare puzzle

Congress revisits the Medicare radiation oncology rate controversy

March 24, 2025
By Mark McCarty
The U.S. Medicare program took several bites out of rates paid for radiation oncology services under the physician fee schedule, but stakeholders are again gaining traction on Capitol Hill with a plea for intervention.
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Dollar sign between hands

Alcon to acquire Lensar for up to $430M

March 24, 2025
By Annette Boyle
Alcon AG plans to acquire Lensar Inc. for up to $430 million in a transaction expected to close in the latter half of the year. The acquisition will add Lensar’s Ally robotic cataract laser treatment system, Streamline software technology and Lensar legacy laser system to Alcon’s cataract surgery portfolio and expand global access to Lensar’s femtosecond laser technology.
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