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Home » Authors » Annette Boyle

Articles by Annette Boyle

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.
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Freestyle Libre 3 sensor with smartphone app

Abbott shows glucose monitors improve GLP-1 outcomes

March 8, 2024
By Annette Boyle
Reports of the death of the market for continuous glucose monitors in individuals with type 2 diabetes are greatly exaggerated, Abbott Laboratories studies show. Far from being unnecessary given the enthusiastic uptake of GLP-1 drugs, the devices significantly improve blood glucose control regardless of the drug used, duration of SLP-1 therapy or use of insulin, presentations at the International Conference on Advanced Technologies & Treatments for Diabetes in Florence, Italy, demonstrated.
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Dexcom Stelo

FDA clears Dexcom Stelo as first OTC continuous glucose monitor

March 7, 2024
By Annette Boyle
In a grand slam for Dexcom Inc., the U.S. FDA cleared its Stelo glucose biosensor system for over-the-counter marketing, making it the first integrated continuous glucose monitor available without a prescription. Designed for use by the 25 million adults with diabetes who do not use insulin and do not have problematic hypoglycemia, the FDA indication expanded the clearance for Stelo to include individuals without diabetes “who want to better understand how diet and exercise may impact blood sugar levels,” dramatically expanding the market opportunity.
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EnsoETM

Haemonetics to acquire Attune Medical for cool $160M

March 6, 2024
By Annette Boyle
Haemonetics Corp. appears ready to make a bit of a retro investment, as it entered into a definitive agreement to acquire Advanced Cooling Therapy Inc. (dba Attune Medical) for $160 million at closing plus undisclosed additional contingent payments. Attune manufactures the U.S. FDA-cleared Ensoetm device, which cools the esophagus during radiofrequency cardiac ablation procedures, a treatment for atrial fibrillation whose days appeared numbered.
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Illustration of tau proteins in Alzheimer's disease

U.S. first: Neurocode launches Alzpath Alzheimer’s blood test

March 4, 2024
By Annette Boyle
Neurocode USA Inc. added Alzpath Dx, a blood test for Alzheimer’s disease screening, to its lab developed tests, making it the first available for commercial use in the U.S. The move stands to make screening for the neurodegenerative disease much more accessible, as recent study results indicate Alzpath’s accuracy rivals PET scans and cerebrospinal fluid tests, the current gold standards, in detecting the signature biomarkers of the disease.
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Boston Scientific Corporation AGENT Drug Coated Balloon

FDA approves ‘needle-moving’ Boston Scientific’s Agent balloon

March 1, 2024
By Annette Boyle
On March 1, Boston Scientific Corp.’s Agent drug-coated balloon (DCB) became the first DCB to gain U.S. FDA approval for treatment of in-stent restenosis in patients with coronary artery disease. With more than 100,000 patients already treated in Europe, Latin America and Japan, it’s no secret Agent provides significant benefit compared to balloon angioplasty or drug-eluting stents (DES) for the approximately 10% of patients with coronary stents who experience subsequent narrowing of the treated vessel.
Read More
Biosense Webster VARIPULSE LA Map

Biosense Webster continues PFA approval trend, nabs CE mark for Varipulse

Feb. 29, 2024
By Annette Boyle
Continuing the spate of regulatory approvals for pulsed field ablation (PFA) devices around the world, Johnson & Johnson’s Biosense Webster Inc. unit secured CE mark for the Varipulse platform for treatment of symptomatic, drug-refractory recurrent paroxysmal atrial fibrillation.
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Stock merger illustration

Bruker acquires molecular diagnostics provider Elitech for €870M

Feb. 28, 2024
By Annette Boyle
Continuing its aggressive buying spree, Bruker Corp. entered into a definitive share purchase agreement with Tecfin S.à r.l. to acquire molecular diagnostics (MDx) company Elitechgroup SAS for €870 million (US$943.5 million), excluding the Elitech clinical chemistry business. The deal is expected to close in the second quarter of 2024 and will be funded with a mix of cash on hand and debt financing.
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Alamar Biosciences Inflammation

Alamar Biosciences scoops up $128M for proteomics platform

Feb. 27, 2024
By Annette Boyle
Alamar Biosciences Inc.’s substantially oversubscribed series C pushed the company’s total funds raised to $250 million. The company closed the first $100 million on Feb. 26 and expects to close an additional $28 million within 30 days. The target for the series C was $100 million. The funds will be used to drive market adoption of its Argo HT system and nucleic acid linked immune-sandwich assay sequencing (NULISAseq) inflammation panel 250 for deep profiling of immune response.
Read More
MIRA Virtual Incision

Virtual Incision’s miniature robotic surgery device gets FDA nod

Feb. 26, 2024
By Annette Boyle
The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics.
Read More
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