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Evolut now has CE mark for low-risk patients and has new labelling for bicuspid use
Evolut Medtronic has been awarded CE mark for the use of the Evolut transcatheter aortic valve implantation (TAVI) system for patients with severe native aortic stenosis who are at low surgical risk. [...]
Miracor Medical’s PiCSO System receives CE mark
Picso system Miracor Medical has announced the award of the CE mark for its latest generation of PiCSO Impulse Catheter and PiCSO Impulse Console, which is indicated for the treatment of anterior [...]
Foldax closes US$20 million financing
Foldax has announced the closing of a $20 million Series D round of funding. According to a press release, MemorialCare Innovation Fund (MCIF) led the round, with Angel Physicians Fund (APF) and Sayan Bioventures [...]
Rexgenero acquires assets of aratinga.bio SAS Group
A press release reports that Rexgenero has acquired all the key technology and program assets of aratinga.bio SAS Group. It adds that the acquisition, which follows the recent approval by the French Commercial Court, [...]
Abiomed initiates online education platform for PCI
Members of CAMP PCI’s faculty take questions from physician participants during the first virtual training on 5 June 2020, broadcast live from Abiomed’s Heart Recovery Institute Abiomed has launched a virtual physician [...]
Vaseem Mahboob steps down as CFO of Endologix
Endologix has announced that Vaseem Mahboob, chief financial officer (CFO), will be departing the company effective 1 July 2020 to become CFO of a private global healthcare company. Cindy Pinto, vice president, Financial Planning [...]
Smartphone could be used to detect fluid in the lungs
A study, by Offer Amir (Heart Institute, Hadassah Medical Centre, Jerusalem, Israel) and colleagues, indicates that voice analysis by a smartphone app could be used to identify lung congestion in heart failure patients, allowing [...]
Medtronic receives US FDA approval for Cobalt and Crome implantable ICDs
Cobalt ICD Medtronic has received FDA approval for its Cobalt and Crome implantable cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy-defibrillators (CRT-D). ICDs monitor heart rhythms and deliver therapy to correct heart rates that [...]
Cook Medical and Surmodics reach distribution agreement for two new vascular products
Cook Medical and Surmodics have announced an agreement in which Cook Medical will distribute two new Surmodics products, hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheters that can be used over 0.014-inch and a 0.018-inch [...]
Terumo Aortic announces FDA approval for Treo endovascular device
Treo stent graft Terumo Aortic has announced that the FDA has granted approval of the Treo abdominal aortic stent-graft system for sale in the USA for the treatment of patients with abdominal aortic aneurysms [...]
FDA clears Aspire MAX mechanical thrombectomy system
Aspire MAX mechanical thrombectomy system Control Medical Technology has announced that the US Food and Drug Administration (FDA) has cleared its Aspire MAX 7 – 11F mechanical thrombectomy platform to remove blood clots from [...]
Wearable necklace-ECG can detect abnormal heart rhythm
Necklace-ECG A necklace that detects abnormal heart rhythm will be showcased for the first time on EHRA Essentials 4 You, a scientific platform of the European Society of Cardiology (ESC). According to the study’s author, [...]
LifeSignals receives CE mark for the ECG Remote Monitoring Patch
LifeSignal remote monitoring patch LifeSignals has received CE mark approval for the LifeSignals ECG Remote Monitoring Patch, a disposable wireless remote monitoring system, intended for use by healthcare professionals for continuous collection [...]
CE mark for SuperSaturated oxygen therapy
TherOX DS2 ZOLL Medical has received CE Mark approval to market and distribute its SuperSaturated oxygen (SSO2) therapy system in Europe. A press release reports that SSO2 therapy provides interventional cardiologists with [...]
Newer generations of MitraClip associated with greater reduction in mitral regurgitation than previous version
Source: BIBA MedTech Insights At the American College of Cardiology/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual; 28–30 March, Chicago, USA), D Scott Lim (University of Virginia, Charlottesville, USA) reported that [...]
COVID-19: Survey suggests increased operating days may be required to clear elective backlog
A BIBA MedTech Insights survey indicates that 50% of centres performing structural heart procedures believe that they will need to increase the number of operating days per week to manage the elective cases that have been [...]
Abiomed acquires novel ECMO developer Breethe
Abiomed (maker of the Impella heart pump) has acquired Breethe, developer of a novel extracorporeal membrane oxygenation (ECMO) system. A press release reports that the acquisition will complement and expand Abiomed’s product portfolio to more [...]
Artio Medical appoints Nathaniel Hagedorn to board of directors
Nathaniel Hagedorn Artio Medical has announced the appointment of entrepreneur and businessman Nathaniel Hagedorn to its board of directors. As the founder and CEO of NorthPoint Development, Hagedorn has raised over $6.5B [...]
Terumo Aortic announces US FDA breakthrough device designation for Thoraflex Hybrid device
Thoraflex Hybrid stented device Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its Thoraflex Hybrid stented device for complex aortic arch repair. The purpose [...]
COVID-19: Virus leads to ATEC terminating acquisition of EOS imaging
EOSedge Alphatec Holdings (ATEC) has terminated the tender offer agreement (TOA), dated 26 February 2020, under which it was to acquire EOS imaging for up to US$88 million in a combination of [...]