Senseonics (NYSE:SENS) announced today that it completed its ENHANCE pivotal clinical study adult cohort for its 365-day Eversense CGM. Germantown, Maryland-based Senseonics' ENHANCE study recorded the completed 365-day visit for the final study … [Read More...] about Senseonics completes 365-day CGM study cohort
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Introduce New Drug Delivery Medical Devices with Lower Risk and Higher ROI
Manufacturing automation is crucial to achieving the precision, quality, and volume required in the medical device industry. Advanced robotics, AI, modular designs, and wireless technology offer the … [Read More...] about Introduce New Drug Delivery Medical Devices with Lower Risk and Higher ROI
Featured Posts
Ypsomed has a new CFO, board member
Ypsomed announced today that it selected Samuel Künzli to take over the company's chief financial officer (CFO) position. Niklaus Ramseier elected to hand over the reins to the CFO position after more than 20 years in the post. The transition … [Read More...] about Ypsomed has a new CFO, board member
Abbott: Real-world data indicates GLP-1s could be accelerator for FreeStyle Libre
New real-world data from Abbott (NYSE:ABT) demonstrates a potentially positive impact of GLP-1 drugs on diabetes technology. GLP-1 receptor agonists, like Ozempic and Wegovy, provide therapy for diabetes and weight loss. This therapeutic class, a … [Read More...] about Abbott: Real-world data indicates GLP-1s could be accelerator for FreeStyle Libre
Satio wins $3.5M contract to develop at-home transdermal drug delivery device
Satio announced that a National Institutes for Health agency awarded it a $3.5 million Small Business Innovation Research (SBIR) contract. Awarded by the NIH's Advanced Research Projects Agency for Health (ARPA-H), the contract helps the company … [Read More...] about Satio wins $3.5M contract to develop at-home transdermal drug delivery device
Know Labs prices $7M public offering
Know Labs (NYSE:KNW) announced today that it priced an underwritten public offering worth about $7 million in proceeds. Seattle-based Know Labs, which develops a non-invasive glucose monitor, is offering 28 million shares of common stock. It … [Read More...] about Know Labs prices $7M public offering
Senseonics completes 365-day CGM study cohort
Senseonics (NYSE:SENS) announced today that it completed its ENHANCE pivotal clinical study adult cohort for its 365-day Eversense CGM. Germantown, Maryland-based Senseonics' ENHANCE study recorded the completed 365-day visit for the final study … [Read More...] about Senseonics completes 365-day CGM study cohort
Dexcom, RxFood partner on AI-based nutrition, glucose monitoring for diabetes management
Dexcom (Nasdaq:DXCM) announced that it teamed up with RxFood on a digital diabetes solution for people in Canada. The first-of-its-kind partnership combines Dexcom's continuous glucose monitoring (CGM) with RxFood's AI-driven personalized … [Read More...] about Dexcom, RxFood partner on AI-based nutrition, glucose monitoring for diabetes management
Abbott completes Bigfoot Biomedical acquisition
Abbott (NYSE:ABT) announced today that it completed its previously announced acquisition of Bigfoot Biomedical. Pursuant to the terms of the merger agreement, upon completion, Bigfoot became a wholly-owned subsidiary of Abbott. The companies … [Read More...] about Abbott completes Bigfoot Biomedical acquisition
Medtronic wins CE mark for next-gen Simplera CGM with InPen integration
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its new Simplera continuous glucose monitor (CGM). The all-in-one, disposable CGM features a simple, two-step insertion process for people with diabetes using multiple … [Read More...] about Medtronic wins CE mark for next-gen Simplera CGM with InPen integration
FDA requests more info on neffy needle-free epinephrine
ARS Pharmaceuticals (Nasdaq:SRPY) says the FDA issued a complete response letter (CRL) regarding its neffy epinephrine nasal spray. The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 … [Read More...] about FDA requests more info on neffy needle-free epinephrine
Ypsomed concludes autoinjector supply deal with Novo Nordisk
Ypsomed announced today that it concluded a long-term supply agreement with Novo Nordisk for large quantities of autoinjectors. Burgdorf, Switzerland-based Ypsomed designed the autoinjectors to administer drugs for the self-treatment of metabolic … [Read More...] about Ypsomed concludes autoinjector supply deal with Novo Nordisk
In case you missed it
- Elutia raises $26M for drug-eluting biomatrix tech
- Abbott, WeightWatchers unveil connected diabetes app
- Dexcom One CGM sensor launches in France with reimbursement
- Vaxess raises $9M to support shelf-stable vaccine patch
- Bausch+Lomb launches $1.4B offering to finance XIIDRA eye drop buy
- Senseonics enters into $50M loan facility
- Analysts: GLP-1 drugs should have minor impact on insulin pump market — but will boost CGMs
- Admetsys wins FDA breakthrough nod for automated glucose control tech
- Abbott to acquire insulin management company Bigfoot Biomedical
- GLP-1 startup i2o looks to revive diabetes drug-eluting implant from Intarcia
- Lawsuit alleges ‘potentially problematic’ patient data sharing from Medtronic Diabetes devices
- FDA clears VVT Medical varicose veins treatment device
- Glucotrack tabs former Medtronic veteran for a board director spot
- Beta Bionics closes $100M Series D to support bionic pancreas
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Clinical Trials
Senseonics completes 365-day CGM study cohort
Senseonics (NYSE:SENS) announced today that it completed its ENHANCE pivotal clinical study adult cohort for its 365-day Eversense CGM. Germantown, Maryland-based Senseonics’ ENHANCE study recorded the completed 365-day visit for the final study patient. The study evaluates the year-long implantable continuous glucose monitor in adults. It also has a pediatric cohort (ages 14 to 18), […]
Vaxxas wins $3.7M award to support needle-free typhoid vaccine tech
Vaxxas announced that it received a $3.67 million award to conduct studies of a typhoid vaccine delivered by its needle-free device. The company develops a vaccine patch based on its proprietary HD-MAP delivery technology. Vaxxas designed its HD-MAP technology to use an ultra-high-density array of micro projections, invisible to the human eye. Applied to the […]
2-year data backs DarioHealth digital diabetes platform
DarioHealth (Nasdaq:DRIO) today announced new research demonstrating sustainably improved outcomes with its digital diabetes platform. New York-based DarioHealth designed its digital health solutions to combine a clinically intelligent platform with consumer insights. It helps to drive sustainable behavior change to improve the management of chronic conditions, including diabetes. The research, presented at the ADCES23 Annual […]
Advanced NanoTherapies picks up $4M investment for drug-coated balloon development
Advanced NanoTherapies announced today that it collected a $4 million Series A extension from an undisclosed strategic investor. Los Gatos, California-based Advanced NanoTherapies received the investment from a medical device company. It also announced the successful treatment of the first cohort of study participants in its drug-coated balloon trial. The first-in-human trial evaluates initial short-term […]
Orchestra BioMed wins FDA IDE for drug-coated balloon study
Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its Virtue SAB. The IDE enables the Virtue ISR-US pivotal study. It evaluates Virtue SAB, a novel AngioInfusion balloon for treating artery disease, in treating patients with coronary ISR. New Hope, Pennslyvania-based Orchestra BioMed designed Virtue SAB to enable the protected […]
