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Diagnostics

Roche invests $550M to make Indianapolis a CGM manufacturing hub

May 12, 2025 By Sean Whooley

Roche Accu-Chek SmartGuide CGM

Roche announced today that it plans to invest up to $550 million to expand its continuous glucose monitoring (CGM) site in the U.S. The company plans to invest in its Diagnostics site in Indianapolis in a project that runs through 2030. It expects to make the site — which serves as the North American headquarters […]

Filed Under: Business/Financial News, Diabetes, Diagnostics, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: Roche, Roche Diabetes Care

Satio, Nanowear collab to bring AI-powered biomarkers to drug delivery

April 14, 2025 By Sean Whooley

Satio intradermal drug delivery system screenshot

Satio and Nanowear today announced that they partnered to advance patient-friendly, home-based diagnostic and therapeutic care. The collaboration aims to integrate Nanowear’s at-home AI-based nanotechnology biomarker diagnostic platform with Satio’s at-home blood draw diagnostics and drug delivery systems/patches. This would combine time-synchronous, in vivo and in vitro diagnostics for precision therapeutics and individualized AI-based risk […]

Filed Under: Big Data, Business/Financial News, Diagnostics, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: Nanowear, Satio

Nanowear enters CGM licensing, data partnership with Dexcom

March 25, 2025 By Sean Whooley

Dexcom G7 Wearable Top (1)

Nanowear announced today that it entered into a partnership with Dexcom to ingest glucose data from its latest continuous glucose monitors (CGMs). The partnership will see Nanowear’s SimpleSense nanotechnology-enabled wearable, mobile and software diagnostics platform take data from the Dexcom G7 CGM, combining continuous glucose readings, blood pressure, ECGs, lung volume, respiration and hemodynamics. This […]

Filed Under: Big Data, Business/Financial News, Diabetes, Diagnostics, Featured, Patient Monitoring, Technology Tagged With: Dexcom, Nanowear

Orange Biomed to showcase microfluidic-based A1C test

September 10, 2024 By Sean Whooley

Orange Biomed rapid a1c

Orange Biomed announced today that it plans to showcase its microfluidic-based A1C test at the 2024 Diabetes Technology Meeting. The company intends to present research for the device during the event’s Startup Showcase next month. It developed the pocket-sized, single-cell, micro-electro-mechanical A1C analysis device, agnostic to hemoglobin variants, to deliver faster, more reliable results for […]

Filed Under: Business/Financial News, Diabetes, Diagnostics, Featured, Technology Tagged With: Orange Biomed

CorFlow Therapeutics raises $48.5M for diagnostic, drug delivery platform

September 10, 2024 By Sean Whooley

CorFlow Logo (1)

CorFlow Therapeutics announced today that it raised €44 million ($48.5 million) to support its novel diagnostic and drug delivery platform. Broadview Ventures and Panakes Partners led the financing round. 415 Capital, Merieux Equity Partners, Merieux Equity Partners, Laerdal Million Lives Fund, Wellington Partners, M&L Investments, Unorthodox Ventures, KOFA Healthcare and Monte Carlo Capital also participated. […]

Filed Under: Business/Financial News, Cardiovascular, Clinical Trials, Diagnostics, Drug-Device Combinations, Funding Roundup, Implants Tagged With: CorFlow

Know Labs data backs non-invasive sensor for glycemic status screening

July 11, 2024 By Sean Whooley

Know Labs KnowU non-invasive blood glucose monitor rendering

Know Labs (NYSE:KNW) today shared new data highlighting the use of its non-invasive blood glucose sensor in glycemic status monitoring. The Seattle-based company published its peer-reviewed study in Diabetes Technology & Therapeutics Journal. The published results demonstrated that Know Labs’ proprietary non-invasive radiofrequency (RF) dielectric sensor and trade-secret machine learning (ML) algorithms correctly classified an individual’s glycemic […]

Filed Under: Clinical Trials, Diabetes, Diagnostics, Featured, Patient Monitoring, Technology Tagged With: Know Labs

Abbott wins FDA clearance for its Lingo OTC glucose monitor

June 3, 2024 By Chris Newmarker

This is an Abbott marketing image of its Lingo over-the-counter continuous glucose monitoring system.

Abbott (NYSE: ABT) has secured a 510(k) clearance from the FDA for its over-the-counter Lingo glucose-monitoring biowearable.  The clearance came on May 29, according to a listing on the FDA’s website. An Abbott spokesperson said the company was aware of the clearance and would provide more details later. FDA clearance for Abbott’s Lingo comes more […]

Filed Under: Diabetes, Diagnostics, Featured, Regulatory/Compliance Tagged With: abbott, CGM

Orange Biomed unveils at-home A1c test in the U.S.

April 19, 2023 By Sean Whooley

Orange Biomed OBM rapid A1c

Orange Biomed announced today that it commenced a U.S. launch as it looks to fill testing gaps for pre-diabetes and diabetes. Seoul, South Korea–based Orange Biomed operates out of Research Triangle Park, North Carolina in the U.S. The company currently has ongoing studies for its OBM rapid A1c test. It designed the glycated hemoglobin analyzer […]

Filed Under: Business/Financial News, Diabetes, Diagnostics, Featured, Patient Monitoring Tagged With: Orange Biomed

Researchers tout AI-based diabetes onset prediction method

December 2, 2022 By Sean Whooley

Klick Applied Sciences diabetes research

Scientists at Klick Applied Sciences say they discovered a way to use a continuous glucose monitor (CGM) as a diabetes screening tool. The scientists determined that they can use artificial intelligence (AI) to screen and prevent the chronic health condition. They used machine learning and 12 hours of data from CGMs to determine whether a […]

Filed Under: Diabetes, Diagnostics, Drug-Device Combinations, Featured, Patient Monitoring, Research & Development, Technology Tagged With: Klick Applied Sciences

Dexcom focuses on early diabetes diagnosis as COVID links emerge

June 30, 2022 By Jim Hammerand

A portrait of Dexcom VP of Global Clinical Initiatives Tomas Walker

New evidence is showing that COVID-19 may increase a person’s risk of diabetes, but it could be years until we know for sure. In the meantime, Dexcom (Nasdaq:DXCM) is getting ready, VP of Global Clinical Initiatives Tomas Walker said. Walker recently spoke with Medical Design & Outsourcing to discuss the San Diego-based diabetes device developer’s proactive approach […]

Filed Under: Diabetes, Diagnostics, Featured Tagged With: COVID-19, Dexcom, Diabetes

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