Beacon Biosignals announced today that it received FDA 510(k) clearance for its Dreem 3S wearable electroencephalogram (EEG) headband. The Boston-based company developed Dreem 3S with integrated machine-learning algorithms. The advanced wearable headband captures EEG data from the brain to monitor sleep architecture and aid in diagnosing disturbed sleep. Beacon Biosignals says its easy-to-use device makes […]
Dexcom One CGM sensor launches in France with reimbursement
Dexcom recently announced the availability of its Dexcom One real-time continuous glucose monitor (CGM) in France. The availability of the real-time CGM sensor comes via reimbursement. It brings the technology to half a million more people with diabetes in France. The company secured access to the platform for all patients two years and older with […]
FDA clears 14-day ECG patch, cloud platform from SmartCardia
SmartCardia announced today that it received FDA clearance for its seven-lead, real-time ECG monitoring patch and cloud platform. The regulatory nod marks the second this week for wearable ECG technology. Samsung spinoff Wellysis picked up FDA clearance for its own ECG patch on Sept. 13. Lausanne, Switzerland-based SmartCardia designed its easy-to-wear, cable-free, waterproof patch for […]
Navigation Sciences raises $3M for surgical system that treats lung cancer
Navigation Sciences announced today that it closed the initial $3 million tranche of a $5 million Series B financing round. Brookline, Massachusetts-based Navigation Sciences develops the NaviSci system for use in precision surgery for early-stage lung cancer. The company designed the system to provide surgeons with real-time “GPS” guidance during minimally invasive surgery. It enables […]
FDA authorizes Attune Medical’s ensoETM for use in RF ablation procedures
Attune Medical announced today that it received FDA de novo marketing authorization for its ensoETM device in ablation procedures. Chicago-based Attune designed ensoETM to reduce the likelihood of ablation-related esophageal injury. These injuries occur as a result of radiofrequency (RF) cardiac ablation procedures. ensoETM received FDA investigational device exemption (IDE) for this indication just over […]
Ambu wins CE mark for therapeutic gastroscope
Ambu announced that it launched its new, larger-sized gastroscopy solution in Europe after receiving CE mark approval. The aScope gastro large and Ambu aBox 2 expand the company’s gastroenterology (GI) offerings in Europe. It designed and tested the solution in close collaboration with leading GI experts. Ambu targets an expansion of more than 1.5 million […]
GE HealthCare, Mayo Clinic partner on medical imaging, theranostics
Mayo Clinic and GE HealthCare today announced a strategic collaboration aimed at improving radiology practice and therapy delivery. It marks the second collaboration between GE HealthCare and a major hospital this month alone. Last week, the company announced an AI-focused partnership with Massachusetts General Hospital. The Strategic Collaboration for Innovation in Medical Imaging and Theranostics […]
Stryker unveils next-gen minimally invasive surgical camera
Stryker announced today that it unveiled its next-generation 1788 surgical camera platform. Kalamazoo, Michigan-based Stryker designed the fully enhanced, minimally invasive camera to advance surgery across multiple specialties. The all-in-one surgical camera platform offers more vibrant images with balanced lighting. It also features a wider color gamut and clearer delineation of fluorescence signals, Stryker said […]
FDA clears Insight Medbotics’ MRI-compatible surgical robot
Insight Medbotics announced today that it received FDA 510(k) clearance for its IGAR MRI-compatible surgical robot system. Clearance for the Hamilton, Ontario-based company’s robot applies to breast biopsy indications. The company said IGAR is the first and only robotic system designed to work inside an MRI bore to garner this regulatory clearance. It features adaptability […]
Awak raises $20M Series B for wearable dialysis device
Awak Technologies announced today that it raised $20 million in Series B funding to support its dialysis technology. The Singapore-based company designed Awak PD as a wearable and ultraportable peritoneal dialysis (PD) system. It offers patients the freedom to undergo dialysis at home and anywhere on the go. It helps to overcome the challenge of […]
Vaxess raises $9M to support shelf-stable vaccine patch
Vaxess Technologies announced today that it raised an additional $9 million in venture capital funding to support its vaccine delivery technology. Cambridge, Massachusetts-based Vaxess develops a shelf-stable vaccine patch with the potential for self-application. The company’s MiMix system features sustained-release technology for administering vaccines and therapeutics. For vaccines, its controlled release simulates the pace of […]