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BioWorld - Thursday, January 15, 2026
Home » Authors » Annette Boyle

Articles by Annette Boyle

Phraxis Endoforce

Phraxis Endoforce receives FDA approval for anastomosis

May 23, 2025
By Annette Boyle
The U.S. FDA approved Phraxis Inc.’s Endoforce Connector for endovascular venous anastomosis, which eliminates the need for surgical dissection for individuals undergoing hemodialysis for kidney failure. The device is designed to reduce tissue trauma and improve long-term graft performance.
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Businessman and IPO virtual screen

Hinge Health rings NYSE bell as IPO raises $437M

May 22, 2025
By Annette Boyle
Hinge Health Inc.’s flexibility produced big rewards as the digital therapy company for physical rehabilitation finally began trading on the NYSE under the symbol HNGE on May 22 after delaying its IPO twice. Hinge co-founders Daniel Perez and Gabriel Mecklenburg rang the opening bell for the stock exchange to celebrate the offering’s $437 million haul.
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Hands holding torn contract

Medtronic aims to sweeten appeal by unloading diabetes unit

May 21, 2025
By Annette Boyle
Medtronic plc revealed plans to spin off its underperforming diabetes unit as a separate public company during its fourth quarter 2025 earnings call May 21. The company expects to complete the separation within 18 months.
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Medtronic aims to sweeten appeal by unloading Diabetes unit

May 21, 2025
By Annette Boyle
Medtronic plc revealed plans to spin off its underperforming diabetes unit as a separate public company during its fourth quarter 2025 earnings call on May 21. The company expects to complete the separation within 18 months.
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Neurons with dendrites affected by amyloid plaques in Alzheimer's disease

Fujirebio Alzheimer’s test wins first FDA clearance

May 20, 2025
By Annette Boyle
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.
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Lung illustration

Galvanize’s Aliya could enable one-step tumor biopsy and ablation

May 20, 2025
By Annette Boyle
Galvanize Therapeutics Inc.’s Aliya pulsed electrical field system could enable surgeons to perform a biopsy and ablate lung tumors at the same time, a study in the Journal of Surgical Oncology indicates.
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Neurons with dendrites affected by amyloid plaques in Alzheimer's disease

Fujirebio Alzheimer’s test wins first FDA clearance

May 19, 2025
By Annette Boyle
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.
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Freestyle Libre 3 sensor with smartphone app

Abbott studies show CGM users have fewer hospitalizations

May 15, 2025
By Annette Boyle
A pair of studies published in Diabetologia demonstrate that use of continuous glucose monitors (CGMs) reduces hospitalizations in people with type 1 diabetes and in those with type 2 diabetes who use insulin compared to use of capillary blood glucose monitoring. Abbott Laboratories’s REFLECT real-world studies showed that use of its Freestyle Libre CGMs reduced the severity of cardiovascular conditions associated with diabetes and, consequently, led to fewer in-patient stays.
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Figure comparing normal pregnancy to peripartum cardiomyopathy preeclampsia

Mirvie offers preeclampsia risk prediction in US

May 14, 2025
By Annette Boyle
Mirvie Inc. continues the development of precision medicine for pregnancy-related conditions with its Encompass blood test to predict preeclampsia risk and individualized support to head off the life-threatening complication that affects one in 12 pregnancies. The test, which received U.S. FDA breakthrough device designation in 2022, is now available to order online with clinician review via telehealth.
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Businessman and IPO virtual screen

Three med-tech IPOs on the horizon

May 13, 2025
By Annette Boyle
April may not have brought rain to med-tech, but tariffs and financial uncertainty certainly dampened the enthusiasm for IPOs. With those clouds lifting, three companies – Hinge Health Inc., Capsovision Inc., and Omada Health Inc. – appear ready to flower in May, potentially a harbinger of a return to the brisk pace for med-tech IPOs seen in the opening weeks of 2025 when eight companies raised nearly $1 billion.
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