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Home » Authors » Annette Boyle

Annette Boyle

Articles

ARTICLES

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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Hand pointing at digital M&A screen

Quest and Pathai sign multipart collaboration

May 2, 2024
By Annette Boyle
Quest Diagnostics Inc. and Pathai Inc. established a forward-looking deal with multiple components and room for growth. The collaboration includes Quest’s acquisition of Pathai Diagnostics – the division that provides anatomic and digital pathology laboratory services – and licensing of Pathai’s Aisight digital pathology image management system. The companies also said they may work together on development of Pathai’s algorithm products and that Quest will be a preferred provider for Pathai’s biopharmaceutical clinical laboratory services.
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Illustration of brain with electrical activity background

Epitel snags FDA clearance for two epilepsy devices

May 1, 2024
By Annette Boyle
Epitel Inc. received U.S. FDA clearances for two epilepsy-focused technologies that simplify detection and analysis of seizures in patients with suspected epilepsy. The Remi remote electroencephalogram monitoring system is a wearable device that allows patients to continue with their daily activities for extended periods without the restrictions of wires, while still capturing intermittent seizures. The Remi Vigilenz artificial intelligence system uses machine learning to identify and note seizure events in the Remi EEG records.
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