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Home » Authors » Annette Boyle

Articles by Annette Boyle

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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magseed

Hologic to acquire Endomagnetics for $310M

April 30, 2024
By Annette Boyle
Hologic Inc. moved to expand its breast surgery line with the acquisition of Endomagnetics Ltd. (Endomag) for a proposed $310 million. Endomag offers a magnetic system that allows precise localization of tumors in the breast and lymph nodes without the use of radioactive materials or wires, enabling greater preservation of healthy tissue. The transaction is expected to close in the second half of 2024.
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EspritB

FDA approves Abbott’s below-the-knee resorbable scaffold

April 29, 2024
By Annette Boyle
Abbott Laboratories received U.S. FDA approval for its Esprit below-the-knee (BTK) everolimus-eluting resorbable scaffold system for use in chronic limb-threatening ischemia well ahead of the expected second half 2024 time frame. Esprit showed clear superiority to angioplasty in the LIFE-BTK trial presented at last year’s Transcatheter Cardiovascular Therapeutics conference and published in The New England Journal of Medicine.
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Pregnancy

Billiontoone test reduces need for Rhogam in 40% of Rh-negative pregnancies

April 26, 2024
By Annette Boyle
In March, the U.S. FDA reported a major shortage of Rhogam, the anti-D immune globulin most widely used to prevent Rh factor incompatibility in pregnancy. Without treatment, second and subsequent pregnancies can be endangered by antibodies created by the mother. With the shortage, the standard treatment of two shots for all pregnant females with Rh-negative blood can be challenging, but Billiontoone Inc.’s Unity prenatal test can eliminate the need for the immune globulin treatment in 40% of these pregnancies.
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Hyperfine Research - swoop

Hyperfine Swoops into Alzheimer’s care

April 25, 2024
By Annette Boyle
Hyperfine Inc. aims to simplify monitoring of potentially dangerous adverse events associated with amyloid-targeting therapies with the launch of its Capturing ARIA Risk Equitably with Portable MR observational study. The study will evaluate the benefits of the Swoop portable brain MRI system in acquiring images needed to detect amyloid-related imaging abnormalities in Alzheimer’s patients as specified in product labeling.
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Expanse ICE in vessel

FDA clears Expanse Ice system for small vessel aspiration

April 23, 2024
By Annette Boyle
Expanse Ice Inc. received U.S. FDA clearance for its Ice Aspiration system, which is designed to clear blood clots in peripheral vessels. The system uses distal cyclical aspiration to “harness the aspiration power typical of a large bore catheter, but within the slender profile of a much smaller device,” Expanse Founder and CEO Eitan Konstantino said.
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Cancer tumor in breast illustration

Lumicell shines a light on residual breast cancer with FDA approvals

April 22, 2024
By Annette Boyle
Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system.  
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Brain cells and blood vessels

Quest adds pTau217 to Alzheimer’s test portfolio

April 22, 2024
By Annette Boyle
Quest Diagnostics Inc. expanded its Alzheimer’s disease (AD) portfolio with a blood-based biomarker test for phosphorylated tau 217 (pTau217). The test joins the company’s plasma tests for p-tau181, beta-amyloid 42/40 ratio and ApoE genetic risk as well as several cerebrospinal fluid tests for Alzheimer’s.
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Cancer tumor in breast illustration

Lumicell shines a light on residual breast cancer with FDA approvals

April 19, 2024
By Annette Boyle
Lumicell Inc. sees a brighter future now that it has secured U.S. FDA approval for both its new drug application for Lumisight (pegulicianine) optical imaging agent and premarket approval for the Lumicell direct visualization system . The company markets the two together as the Lumisystem to detect and resect residual breast cancer. Newton, Mass.-based Lumicell expects the Lumisystem will be available in the fourth quarter of 2024, Lumicell President and Chief Operating Officer Howard Hechler told BioWorld.
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