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Home » Authors » Annette Boyle

Articles by Annette Boyle

Abbott iSTAT Alinity

FDA clears Abbott’s bedside concussion test

April 1, 2024
By Annette Boyle
It’s game time for Abbott Laboratories’ 15-minute concussion test now that FDA clearance is in hand. The I-Stat traumatic brain injury cartridge uses whole blood, allowing bedside assessment of patients without lab processing.
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Noze

Noze tracks down TB with new grant

March 28, 2024
By Annette Boyle
Noze Inc. is hot on the trail of tuberculosis with its Diagnoze hand-held system that can detect the disease by its smell. The company, formerly known as Stratuscent, received additional support from the Bill & Melinda Gates Foundation to fund a study evaluating a breathalyzer designed to detect tuberculosis in high-burden countries.
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Abbott Labs Assert-IQ-AIQ

Abbott secures CE mark for Assert-IQ insertable cardiac monitor

March 27, 2024
By Annette Boyle
Abbott Laboratories landed CE mark for two versions of its Assert-IQ insertable cardiac monitor (ICM), one with a three-year battery life, the other lasting six years. Designed for long-term remote monitoring of individuals with abnormal heartbeats or at risk of developing arrhythmias, the device helps detect often-fleeting irregularities in heart rhythm to assist in diagnosis and care management.
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Neurostar

Neurostar cleared for use in adolescent depression

March 26, 2024
By Annette Boyle
The U.S. FDA granted Neuronetics Inc. clearance for use of its Neurostar advanced therapy as an adjunctive treatment of major depressive disorder in patients aged 15 to 21, making it the first transcranial magnetic stimulation treatment (TMS) cleared for this age group, the company said.
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Masimo

Sound decision: Masimo to split off consumer business

March 25, 2024
By Annette Boyle
Less than two years after acquiring Sound United for $1.025 billion, Masimo Corp. plans to hive off the consumer audio subsidiary along with consumer health products such as its Stork baby monitor and Freedom smart watch and band. The “rushed” announcement made Friday “came after being informed that Politan intended to nominate directors this week,” said activist investor Politan Capital Management. Politan, which owns 8.9% of the company, secured two board seats in a highly contentious proxy battle last year and nominated two more on Monday morning.
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Stimlabs Relese

FDA clears Stimlabs’ Corplex P for wound care

March 22, 2024
By Annette Boyle
Stimlabs LLC received U.S. FDA approval for Corplex P, a wound care product that uses placental tissue to facilitate wound healing. “Corplex P is the first particulate device derived from human umbilical cord extracellular matrix indicated for the management of acute and chronic wounds,” Stimlabs CEO John Daniel told BioWorld.
Read More
Hands holding torn contract

European Commission blasted for action on Illumina-Grail merger

March 21, 2024
By Annette Boyle
An advocate general (AG) for the E.U. Court of Justice did not mince words in calling out the European Commission for its “very significant extension of the scope of the Merger Regulation and of the commission’s jurisdiction” in reviewing Illumina Inc.’s $7.1 billion acquisition of Grail LLC.
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Illustration of Alzheimer’s in the brain.

Labcorp adds Alzheimer’s screening test

March 20, 2024
By Annette Boyle
Laboratory Corporation of America Holdings expanded its blood biomarker test portfolio for Alzheimer’s disease, making its pTau217 test available by prescription in the U.S. as well as for research globally. The standalone test can also be used in monitoring patients undergoing treatment for the neurodegenerative disease.
Read More
Device in heart

CRT 2024: Strong results for TAVR across risk groups

March 12, 2024
By Annette Boyle
The Cardiovascular Research Technologies 2024 conference in Washington this week demonstrated continued positive outcomes for patients who underwent transcatheter aortic valve replacement with devices made by Abbott Laboratories, Edwards Lifesciences Corp. or Medtronic plc.
Read More
Roche Accu-Check CGM

Roche introduces new glucose monitor, but why?

March 11, 2024
By Annette Boyle
Roche AG debuted a new continuous glucose monitor (CGM) at the Advanced Technologies & Treatments for Diabetes conference in Florence, Italy, last week, but how appealing users will find it remains unclear – as is the market opportunity given the entrenched position of Abbott Laboratories and Dexcom Inc.
Read More
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