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BioWorld - Sunday, May 11, 2025
Home » Authors » Annette Boyle

Articles by Annette Boyle

FARAPULSE pulsed field ablation system
HRS 2024

Pulsed field ablation electrifies the market

May 20, 2024
By Annette Boyle
Pulsed field ablation dominated the news out of the Heart Rhythm Society meeting this week with three late-breaking studies highlighting the safety and efficacy of the technology replacing thermal ablation for treatment of atrial fibrillation and active discussion of the ‘unprecedented’ growth of these procedures. Boston Scientific Corp’s Farapulse is rapidly building dominance in the field, while results from Johnson & Johnson’s Varipulse study and Medtronic plc’s trial of the Affera system set up those companies for U.S. FDA approval later this year.
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Gloved hands holding a heart

Caredx Heartcare quickly IDs organ rejection, improves outcomes

May 17, 2024
By Annette Boyle
The Surveillance Heartcare Outcomes Registry trial demonstrated that Caredx Inc.’s Heartcare test identifies acute cellular rejection in heart transplant patients better than donor-derived cell-free DNA (dd-cfDNA) alone, while reducing biopsies and improving clinical outcomes. Heartcare combines two non-invasive tests, dd-cfDNA and Allomap Heart gene-expression profiling.
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Flower with dollar sign

May Health raises $25M to treat PCOS

May 16, 2024
By Annette Boyle
May Health SAS closed a $25 million series B financing round to advance its Ovarian Rebalancing therapy for polycystic ovary syndrome (PCOS)-related infertility. The round brings the total funds raised by the Paris-based company to date to $35 million, May Health CEO Anne Morrisey told BioWorld.
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Neural Ice

Brixton comforted by $33M series B for pain relief therapy

May 15, 2024
By Annette Boyle
Brixton Biosciences Inc. closed a $33 million series B funding round that it plans to immediately use to pursue two clinical trials to evaluate the use of its Neural Ice nerve block for knee pain. The injectable product received U.S. FDA breakthrough device designation in October.
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3D illustration showing presence of tumor inside prostate gland

Profound snags FDA clearance for prostate disease contouring module

May 14, 2024
By Annette Boyle
Profound Medical Corp. received U.S. FDA 510(k) clearance for its second transurethral ultrasound ablation (TULSA) module using artificial intelligence. When used with Profound’s TULSA-Pro system, the Contouring assistant helps physicians more quickly and accurately segment prostate imaging and design treatments.
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Endologix DETOUR

DETOUR2 shows Endologix superficial femoral artery bypass on track

May 13, 2024
By Annette Boyle
One-year results of the DETOUR2 trial published in the Journal of Vascular Surgery demonstrate outstanding results for Endologix LLC’s percutaneous transmural arterial bypass system for treatment of severe peripheral artery disease. The study showed nearly all patients experienced improvement in acute limb ischemia with freedom from occlusion of 92% and freedom from revascularization of nearly 88% at 12 months.
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FieldForce Catheter

Field Medical begins first-in-human trials for ventricular PFA

May 9, 2024
By Annette Boyle
Field Medical Inc. kicked off its first-in-human study for its Fieldforce ablation system, designed for use in ventricular arrhythmias. The Ventricular Catheter Ablation Study study will enroll 60 patients in five centers around the world, most recently kicking off in the Na Homolce Hospital in Prague, Czech Republic.
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Colon cancer illustration

FDA greenlights Geneoscopy’s Colosense colorectal cancer screening test

May 8, 2024
By Annette Boyle
This time a positive result for a cancer screening test brought good news, as Geneoscopy Inc. secured U.S. FDA approval for its RNA screening test for colorectal cancer. The agency based its decision on strong results from the phase III CRC-PREVENT trial in its approval of the noninvasive test for use in individuals aged 45 years and older with average risk for the disease.
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Masimo Stork

Masimo’s Stork takes flight with FDA’s over-the-counter clearance

May 6, 2024
By Annette Boyle
Masimo Corp.’s pride and joy, the Stork baby monitor, achieved a new developmental milestone with U.S. FDA clearance for over-the-counter marketing. The agency cleared Stork, which monitors key vital signs including oxygen saturation level, pulse rate and skin temperature, for use on a prescription basis in December. It has been available in the U.S. as a health and wellness device since August 2023.
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Blood cells and bacteria

Cytovale’s Intellisep rules out sepsis in 97.5% of cases

May 3, 2024
By Annette Boyle
Cytovale Inc. has posted a feverish run of wins lately. The company gained U.S. FDA clearance for its Intellisep rapid test for sepsis in January 2023, raised $84 million in a series C in November and just published results showing the test has negative predictive value of 97.5%.
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