The European Commission has conducted a surprise inspection at an undisclosed medtech company active in the cardiovascular space. The news release, posted yesterday on the Commission’s website, mentioned concerns that the inspected company may have violated EU antitrust rules that prohibit abuses of a dominant market position. Other details were not provided, including the identity […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
InBrain Neuroelectronics wins FDA breakthrough nod for intelligent network modulation system
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 […]
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 […]
Moon Surgical picks up CE mark for updated Maestro surgical robot
Moon Surgical announced today that it received CE mark approval in Europe for the latest version of its Maestro surgical robot system. The initial version of Maestro received CE mark approval earlier this year in April. This milestone marks the latest in a string of positive updates for Moon Surgical, which raised $55.4 million in […]
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 […]
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 […]
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 […]
