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

Articles by Annette Boyle

Global currency

GSR and EY see more rational investment in 2023 and more M&A, thanks to tough 2022

Jan. 27, 2023
By Annette Boyle
GSR Ventures, a venture firm focused on early stage digital health companies, forecasts a much brighter investment picture for 2023 following a hard reset in 2022, said GSR Partner Sunny Kumar in an interview with BioWorld at the J.P. Morgan Healthcare Conference in San Francisco.
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Abbott - Proclaim

Abbott receives FDA approval for diabetic peripheral neuropathy device

Jan. 26, 2023
By Annette Boyle
The U.S. FDA approved the Proclaim XR spinal cord stimulation system by Abbott Laboratories for painful diabetic peripheral neuropathy (DPN). The system offers an alternative to patients for whom oral medications do not provide sufficient relief. About half of individuals with diabetes will eventually develop peripheral neuropathy which primarily damages the nerves running down the legs to the feet.
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Biobeat Watch

Biobeat adds FDA clearances for stroke volume and cardiac output using PPG

Jan. 25, 2023
By Annette Boyle
Biobeat Technologies Ltd. expanded its U.S. FDA-cleared remote patient monitoring offerings with a double nod from the agency for its sensors to monitor stroke volume and cardiac output. The two new indications join its capabilities for measuring the five vital signs assessed in any medical visit—blood pressure, blood oxygen saturation, pulse rate, respiratory rate and body temperature—all of which can be done using photoplethysmography (PPG) on sensors embedded on either a short-term chest patch or a more durable wrist monitor.
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Oncohost

Oncohost partners with US research institutions to analyze resistance mechanisms in cancer

Jan. 24, 2023
By Annette Boyle
Oncohost Ltd., Baylor Scott & White Research Institute and the Translational Genomics Research Institute (TGen) have joined forces in a five-year study to improve personalized cancer therapy by better understanding resistance mechanisms. The team will analyze host response, patient microbiome, tumor DNA and immune system activity of 350 patients with non-small cell lung cancer (NSCLC).
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Dialysis patient Vasc-Alert

Vasc-Alert algorithm reliably predicts vascular access blockages in dialysis patients

Jan. 23, 2023
By Annette Boyle
Vasc-Alert LLC’s surveillance technology successfully predicts which dialysis patients are at risk of experiencing stenosis, a study published in the Journal of Vascular Access shows. Patients assigned high scores by the company’s algorithm had seven times the risk of stenosis and blockage compared to those with low-risk scores.
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Selux

FDA can’t resist Selux rapid antibiotic susceptibility testing platform

Jan. 20, 2023
By Annette Boyle
Selux Diagnostics Inc. received U.S. FDA 510(k) clearance for its next generation phenotyping (NGP) system, a rapid antibiotic susceptibility test (AST) platform that determines a bacteria’s susceptibility to 14 specific antimicrobial agents in less than six hours. Prompt identification of the narrowest effective antimicrobial for an infection is critical to the battle to preserve the efficacy of critical antibiotics and slow the development of ‘superbug’ infections.
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Magstim TMS

FDA clears Magstim TMS device for OCD treatment

Jan. 19, 2023
By Annette Boyle
Magstim Inc. received U.S. FDA clearance for use of its Horizon 3.0 and E-z Cool Coil to treat adult patients diagnosed with both obsessive compulsive disorder (OCD) and major depressive disorder (MDD). The company’s non-invasive transcranial magnetic stimulation (TMS) therapy offers an option for patients who do not find adequate relief from the often life-disrupting symptoms of OCD with exposure therapy or medication.
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Blood cells and bacteria

Cytovale gets FDA nod for 10-minute sepsis test

Jan. 18, 2023
By Annette Boyle

Cytovale Inc. received U.S. FDA 510(k) clearance for its Intellisep sepsis test, which can aid in the diagnosis of the often fatal condition within 10 minutes. Cytovale is one of several companies and collaborations that aim to sharply reduce the time to diagnosis and the mortality rate for sepsis by providing quicker, more informative test results and standardizing protocols.


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Reducer device on balloon

Shockwave to acquire Neovasc for up to $120M

Jan. 17, 2023
By Annette Boyle
Shockwave Medical Inc. will acquire Neovasc Inc. for just under $108 million, if all terms of the deal are met. Shockwave will pay $27.25 in cash for each of Neovasc’s 2.71 million outstanding shares or approximately $73.78 million at close. Shockwave said the offer corresponds to an enterprise value of $100 million. Neovasc could receive an additional payment of up to $47 million, if the company’s Reducer system for refractory angina obtains U.S. FDA marketing approval within a specified time frame.
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Dexcom G7 Family of Products
J.P. Morgan Healthcare Conference

Dexcom presents sweet view of 2023

Jan. 13, 2023
By Annette Boyle
Dexcom Inc. appears poised for a very strong year with multiple new products, including the long-awaited G7, having recently received regulatory green lights in the U.S. and Europe. In addition, recommendations to expand coverage of continuous glucose monitors (CGMs) for individuals with type 2 diabetes promise to open the market to millions of new patients. Dexcom CEO Kevin Sayer provided new details and updated guidance at the J.P. Morgan Healthcare Conference in San Francsico earlier this week and the company released preliminary results for the fourth quarter and full year of 2022.
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