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Home » Authors » Annette Boyle

Articles by Annette Boyle

shockwave-device-c2-plus.jpg

Shockwave completes enrollment in all-female cardiovascular trial

Oct. 29, 2024
By Annette Boyle
Shockwave Medical, a unit of New Brunswick, N.J.-based Johnson & Johnson Medtech, completed enrollment in the first prospective all-female study of percutaneous coronary intervention in complex disease. The real-world, all-comers trial will evaluate the benefits of coronary intravascular lithotripsy in female patients with calcified lesions.
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Johns Hopkins Medicine surgeons performing a kidney transplant.

Paragonix’s Kidney Vault receives FDA nod for organ transport

Oct. 28, 2024
By Annette Boyle
The U.S. FDA cleared Paragonix Technologies Inc.’s Kidneyvault portable renal perfusion system, which combines digital monitoring capabilities and hypothermic perfusion technology to preserve donor kidneys during transportation.
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Medtronic - Affera Mapping and Ablation System

Medtronic’s Affera PFA snags FDA approval

Oct. 25, 2024
By Annette Boyle
Medtronic plc added a second U.S. FDA pulsed field ablation (PFA) device approval to its scorecard with the agency’s greenlight for its Affera mapping and ablation system with the Sphere-9 catheter. Affera brings the first radiofrequency/PFA device to the cardiac ablation market and ups the ante in the PFA competition.
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Galleri instruction booklet on blood draw chair

Real-world study of Grail’s Galleri consistent with trial data

Oct. 24, 2024
By Annette Boyle
Early results from REFLECTION, a real-world study, mirrored results for Grail Inc.'s multi-cancer early detection (MCED) assay in clinical trials, according to a presentation at the 2024 Early Detection of Cancer Conference. The study, conducted at U.S. Department of Veterans Affairs (VA) sites, focuses on the real-world application of the Galleri test, which screens for multiple cancers in asymptomatic individuals.
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Boston Scientific Farapulse PFS system

Boston Sci stuns with 177% Farapulse-driven increase in EP revenue

Oct. 23, 2024
By Annette Boyle
Boston Scientific Corp. posted another eye-popping quarterly report, led by a 177% year-over-year increase in its electrophysiology business to $527 million, which exceeded consensus expectations by $99 million. That stunning EP growth follows 125% growth in the second quarter and 70% in the first quarter, all largely attributed to the Farapulse pulsed field ablation system, which achieved unprecedented adoption rates.
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PRIMA implant

Science Corp.’s Prima enables blind patients to read

Oct. 22, 2024
By Annette Boyle
Preliminary results from a trial demonstrated that Science Corp.’s Prima retina implant restored ‘form vision,’ including the ability to read in patients with vision loss. Originally developed at Stanford University and then advanced by Pixium Vision SA, Prima received U.S. FDA breakthrough device designation in April 2023.
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Farawave system

FDA greenlights navigation system for Boston Sci’s Farapulse

Oct. 21, 2024
By Annette Boyle
Boston Scientific Corp. racked up a two-fer from the U.S. FDA with approval of its navigation-enabled Farawave Nav ablation catheter and 510(k) clearance for the Faraview software for use with its Farapulse pulsed field ablation (PFA) system.
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First To Know Syphilis test

Nowdiagnostics partners with Labcorp to distribute at-home syphilis test

Oct. 18, 2024
By Annette Boyle
Nowdiagnostics Inc. established an exclusive agreement with Labcorp Holdings Inc. for distribution of its First To Know syphilis test in the U.S. The test provides results in 15 minutes with as little as a single drop of blood. The test will be available to hospitals and clinicians by the end of 2024 and offered to patients directly through Labcorp Ondemand in 2025.
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Medtronic - Affera Mapping and Ablation System

FDA OKs study of Medtronic’s Affera in ventricular tachycardia

Oct. 17, 2024
By Annette Boyle
Medtronic plc received U.S. FDA approval to undertake an early feasibility study of its dual-energy Affera cardiac ablation system in sustained ventricular tachycardia. Affera combines both radiofrequency and pulsed field ablation technologies in the Sphere-9 catheter along with high-density mapping.
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Novocure's Optune Lua

Novocure’s tumor treating fields land FDA approval for lung cancer

Oct. 16, 2024
By Annette Boyle
Novocure GmbH secured U.S. FDA approval for Optune Lua, a wearable device that delivers alternating electric fields or tumor treating fields that kill cancer cells. Indicated for use with PD-1/PD-L1 inhibitors or docetaxel in the second or subsequent line for the treatment of metastatic non-small-cell lung cancer following the failure of platinum-based regimens, the approval was driven by the significant improvement in overall survival rates seen in the LUNAR pivotal study for Optune Lua.
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