Stryker (NYSE:SYK) announced today that surgeons began early product surveillance cases for its Q Guidance system with cranial guidance software. Kalamazoo, Michigan-based Stryker designed the Q Guidance System as an image-based planning and intraoperative platform. The company launched the system for spinal applications in September 2022. This latest iteration offers support for cranial surgeries. Stryker received […]
News Well
Abbott CardioMEMS sensor nearly halves heart failure hospitalizations, study says
A recent European study found that the Abbott CardioMEMS HF System resulted in a 44% reduction in heart failure hospitalizations. Abbott also reported today that the study found an improvement in patient-reported quality-of-life scores as early as three months with the implantable remote monitoring sensor. Heart failure is a global health challenge affecting more than […]
Boston Scientific reportedly set to add 400 jobs in Ireland
Boston Scientific (NYSE:BSX) plans a new investment in Ireland that would create more than 400 jobs, according to The Irish Examiner. The Irish Examiner reports that the new investment in Clonmel, County Tipperary, totals $86.3 million (€80 million). Marlborough, Massachusetts-based Boston Scientific plans to expand its manufacturing and R&D capabilities at its existing Clonmel site, the […]
Cala Health, Cue Health have layoffs in California
Cala Health and Cue Health (Nasdaq:HLTH) both recently filed with the state of California to confirm reductions in their workforces. The two companies are the latest to join the long list of medtech companies cutting employees amid a challenging time for the industry. To date, MassDevice has reported on more than 18,000 medtech employees who have been […]
Study supports extravascular ICD from Medtronic
Medtronic (NYSE:MDT) announced positive long-term follow-up results for its investigational implantable cardioverter defibrillator (ICD). The medtech giant designed its extravascular (EV) ICD system to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. Medtronic’s EV ICD pivotal study followed patients through an average of 17.1 months. The company presented data as late-breaking […]
Data backs Abbott Aveir dual-chamber leadless pacemaker
Abbott (NYSE:ABT) today announced late-breaking results from a study of its Aveir dual-chamber (DR) i2i leadless pacemaker. The data came from the company’s large-scale FDA investigational device exemption (IDE) study. It assesses Aveir DR, the world’s first dual-chamber leadless pacemaker for safety and performance. Abbott said the data suggests that Aveir DR could offer new […]
Medtronic reports positive study results for PulseSelect pulsed-field ablation system
Medtronic (NYSE:MDT) today announced positive findings from a secondary analysis of the PULSED AF study for its pulsed-field ablation technology. The analysis demonstrated positive results for the PulseSelect system, including atrial arrhythmia (AA) burden reduction. This correlated to both improved quality of life and decreased healthcare utilization. Medtronic said in a news release that 87% […]
Hologic wins FDA clearance for COVID-flu-RSV assay
Hologic today announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The clearance comes after a winter in which the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV. “This past winter, we saw several respiratory illnesses — COVID, flu and RSV — spreading simultaneously throughout communities and often […]
Abbott wins FDA approval for next-gen TactiFlex ablation catheter
Abbott today announced FDA approval of its TactiFlex Ablation Catheter, Sensor Enabled, which the company describes as the world’s first ablation catheter with a flexible tip and contact force technology. The TactiFlex catheter also integrates with Abbott’s EnSite X EP System, enabling physicians to visualize heart anatomy more precisely, according to the company. The result […]
FDA clears automated insulin pump from Beta Bionics for type 1 diabetes
The FDA announced today that it cleared the Beta Bionics iLet ACE automated insulin pump and iLet dosing decision software. FDA clearance covers the devices for people 6 years of age and older with type 1 diabetes. Combined with a compatible, FDA-cleared integrated continuous glucose monitor (iCGM), they form the iLet Bionic Pancreas. Using an […]
Vicarious Surgical promotes John Mazzola to COO
Vicarious Surgical (NYSE:RBOT) announced that it promoted John Mazzola to the role of chief operating officer (COO). Mazzola joined the Waltham, Massachusetts-based surgical robotics company in March 2022 as SVP of operations. He brings with him more than 35 years of experience in the medical device industry. That includes involvement in more than 25 medical […]
