InBrain Neuroelectronics announced today that it received FDA breakthrough device designation for its intelligent network modulation system. The breakthrough nod covers the graphene-neural platform as an adjunctive therapy for treating Parkinson’s disease. InBrain’s system harnesses the power of graphene, a two-dimensional material made of a lattice of carbon atoms. The thin material — stronger than […]
Food & Drug Administration (FDA)
FDA grants IDE to Orchestra BioMed for cardiac neuromod trial in pacemaker patients
Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its BACKBEAT trial. BACKBEAT (bradycardia pacemaker with atrioventricular interval modulation for blood pressure treatment) evaluates the safety and efficacy of atrioventricular interval modulation (AVIM) therapy. Also known as BackBeat CNT, it treats hypertensive patients indicated for a dual-chamber cardiac pacemaker. New […]
CereVasc wins FDA IDE to expand eShunt trial
CereVasc announced today that the FDA approved an investigational device exemption (IDE) supplement for a study of its eShunt system. The FDA permitted the expansion of the study for patients with normal pressure hydrocephalus (NPH) to additional participants and sites. The company initiated the pilot study of its eShunt system under IDE in August 2022. […]
Inspira submits cardio-pulmonary bypass device for FDA clearance
Inspira Technologies (Nasdaq:IINN) announced that it submitted its Inspira ART100 cardio-pulmonary bypass device for FDA clearance. Ra’anana, Israel-based Inspira designed the system to transform external breathing, empowering breathing without lungs. The company anticipates potential clearance for the system in the first half of 2024. ART100’s bid for 510(k) clearance is backed by a comprehensive usability […]
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 […]
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 […]
Abbott recalls neurostimulation implants for Bluetooth bricking flaw
Abbott has recalled more than 155,000 implantable pulse generators (IPGs) due to a Bluetooth connectivity flaw that has left some devices unusable. The Class I recall — the FDA’s most serious level — covers Proclaim and Infinity IPGs used for three kinds of neurostimulation: Spinal cord stimulation: Proclaim XR 5 IPG Model 3660 (previously known […]
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 […]
Samsung spinoff Wellysis wins FDA nod for wearable ECG
Competition in the wearable ECG space continues to heat up, with Samsung spinoff Wellysis as the latest U.S. market entrant. Seoul, South Korea–based Wellysis announced today that it has secured FDA clearance for its S-Patch Ex. The device already has a CE Mark, with Wellysis marketing the S-Patch Ex in 14 countries. Its markets include […]
FDA clears Pangea trauma systems from Stryker
Stryker (NYSE:SYK) announced today that its Pangea systems — including femur, fibula, tibia, humerus and utility — received FDA 510(k) clearance. Kalamazoo, Michigan-based Stryker designed its Pangea systems with collaborative efforts from world-renowned orthopedic surgeons. The plates offer an evidence-based design for implant fit. The company said in a news release that it designed the […]
Procept BioRobotics wins FDA IDE for Aquablation prostate cancer therapy
Procept BioRobotics (Nasdaq:PRCT) announced today that it received FDA investigational device exemption (IDE) for its Aquablation therapy. The IDE allows Procept to initiate a single-arm feasibility study for the Aquablation prostate cancer therapy in the U.S. Data generated from the study could support future research and regulatory applications in the U.S. The company plans to […]
