Biotronik announced today that the FDA approved its Renamic Neo programmer for implanted cardiac rhythm management devices. Lake Oswego, Oregon-based Biotronik designed its Renamic Neo programmer for implanted devices, including ICDs, pacemakers and implantable cardiac monitors. According to a news release, Renamic Neo offers LifeSupport for clinicians to share the programmer screen with or grant […]
Biotronik
The 18 most innovative medical devices of 2021
The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition. “The Awards Committee is excited to introduce the nominees for the 2021 […]
Biotronik wins FDA clearance for cardiac monitor sensor
Biotronik today announced FDA clearance of its Vital Data Sensor, designed to identify body temperature increases potentially associated with fever, as part of its new Biomonitor IIIm injectable cardiac monitor (ICM). Biomonitor IIIm contains integrated sensors designed to measure patient activity, heart rate and body temperature. The new sensor gives physicians access to daily reports […]
The 18 most innovative medical devices of 2020
The Galien Foundation recently announced nominees for most innovative medical devices for its 14th Annual Prix Galien USA Awards. The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical and technology products that are designed to improve the human condition. “As we celebrate 50 years of the Prix Galien process, we are honored […]
DTW podcast: Connect your devices before it’s too late
Twenty years ago when he was working at the Mayo Clinic, cardiologist Dr. David Hayes shot down the idea that medical devices would serve patients better if equipped with technology that collected and transmitted data. Hayes had many reasons. He said patients liked coming to the doctors’ offices. “I thought they’d miss that connection,” he […]
Medtech manufacturers must add warning label to drug-eluting PAD devices
UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for […]
Acutus Medical, Biotronik ink deal
Acutus Medical and Biotronik have announced that they will collaborate on electrophysiology, mapping, ablation and accessory products across certain markets. The products involved in the collaboration center around the treatment of cardiac arrhythmias in markets that include Europe and Asia, according to a news release. The partnership centers on Acutus’ AcQMap system, which Acutus touts […]
Biotronik touts results of CRT-DX study
Biotronik today touted results confirming that its two-lead CRT-DX system provides equivalent therapy compared to conventional three-lead systems. The CRT-DX systems include a CRT-DX pulse generator and a DX implantable cardioverter-defibrillator (ICD) lead to provide atrial sensing and help reduce complications associated with an additional atrial lead for patients who do not need atrial pacing. […]
Judge tosses wrongful termination suit against Abiomed
Abiomed (NSDQ:ABMD) has convinced a federal judge that whistleblower Max Bennett had no basis on which to claim the company fired him in retaliation for his investigation of federal False Claims Act violations. Judge Indira Talwani ruled on Tuesday that “no reasonable jury could find that Bennett had engaged in protected activity or that he was […]
Biotronik appoints new chief medical officer
Biotronik today said it appointed David Hayes as chief medical officer. Hayes will be responsible for overseeing the development of the company’s cardiovascular solutions and other innovations that can help physicians and health systems deliver patient care. “Our focus has always been on the patient. To help patients live their best lives, we remain in […]
China approves Biotronik’s Orsiro drug-eluting stent
Biotronik said today that China’s National Medical Products Administration approved its Orsiro drug-eluting stent. Orsiro is a cobalt-chromium stent that elutes the drug sirolimus via the Berlin-based company’s Biolute bioabsorbable polymer coating. Biotronik said it plans to have Orsiro on the Chinese market “in the coming months.” Get the full story at our sister site, […]