Roche (SIX: RO, ROP; OTCQX: RHHBY) today announced that the FDA has cleared its Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test that identifies amyloid pathology associated with Alzheimer’s disease. The test is cleared for people 55 and older with signs of cognitive decline to be used in conjunction with clinical information in assessing Alzheimer’s risk. When the FDA approved the first […]
Diagnostics
12 things you need to know about the CGM market
The CGM market is an exciting, fast-growing, multibillion-dollar sector for the medical device industry, according to our latest Medtech Market Intelligence Report for MassDevice. The report on the CGM market — available for purchase on MassDevice — draws on numerous sources, including but not limited to: medical associations, government data, medical journals, leading medtech publications, clinical […]
Orange Biomed takes next step to bringing A1C test device to market
Orange Biomed announced a major milestone on its path to bringing a pocket-sized A1C analysis device to the market. The Seattle-based company received Good Manufacturing Practice (GMP) certification for in vitro diagnostic medical devices from Korea’s Ministry of Food and Drug Safety. This enables it to scale production of the pocket-sized portable diabetes testing device. […]
Roche invests $550M to make Indianapolis a CGM manufacturing hub
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 […]
Satio, Nanowear collab to bring AI-powered biomarkers to drug delivery
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 […]
Nanowear enters CGM licensing, data partnership with Dexcom
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 […]
Orange Biomed to showcase microfluidic-based A1C test
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 […]
CorFlow Therapeutics raises $48.5M for diagnostic, drug delivery platform
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. […]
Know Labs data backs non-invasive sensor for glycemic status screening
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 […]
Abbott wins FDA clearance for its Lingo OTC glucose monitor
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 […]
