Powerful Medical secures CPT code 1139T for Queen of Hearts AI ECG after FDA authorisation
Powerful Medical secures CPT code 1139T for Queen of Hearts AI ECG, opening a US billing pathway while reimbursement remains unresolved.
Medical Devices & Diagnostics
Medical Devices & Diagnostics
Kivo Health raises $10m Series A led by Allumia Ventures to expand AI-powered care for chronic lung disease
Kivo Health raises $10m to expand virtual COPD care, backed by early rehabilitation outcomes and projected savings that still need validation.
Medical Devices & Diagnostics
Vincora secures FDA approval for NeXuS transcatheter chordal repair feasibility study in the US
Vincora gains FDA permission to study its NeXuS mitral repair system in the US, with procedural safety and lasting valve repair now in focus.
Medical Devices & Diagnostics
EQT offers QIAGEN shareholders a 40% premium, but can its €10.8bn diagnostics bet unlock faster growth?
EQT agrees a €10.8 billion takeover of QIAGEN at €46.50 per share. Diagnostics growth, financing and shareholder approval remain key.
Medical Devices & Diagnostics
Johnson & Johnson advances surgical AI network with Abu Dhabi and Polyphonic platform
Johnson & Johnson advances Polyphonic surgical AI deployment in Abu Dhabi. Clinical validation, data governance and hospital adoption will shape its impact.
Medical Devices & Diagnostics
ZAP Surgical secures $36m to expand ZAP-X brain radiosurgery
ZAP Surgical has secured $36 million in financing led by Catalio Capital Management, following shipment of its 50th ZAP-X system and treatment of nearly 10,000 patients worldwide. The investment will support manufacturing expansion and broader access to self-shielded brain radiosurgery.
Medical Devices & Diagnostics
GE HealthCare’s new ultrasound system is 26% faster in testing. Can it reduce imaging bottlenecks?
GE HealthCare has introduced LOGIQ Focus, a general imaging ultrasound system combining cSound Architecture with automated scanning and workflow tools. In a third-party abdominal imaging study, the system completed scans 26% faster than a comparator, while 90% of participating physicians rated image quality highly.
Medical Devices & Diagnostics
Can a pulse oximeter detect atrial fibrillation before symptoms appear? Masimo reports 97% sensitivity
Masimo has received FDA 510(k) clearance for atrial fibrillation detection on its Radius VSM monitor, reporting 97% sensitivity and 100% specificity in clinical validation. The feature joins an earlier-cleared respiratory depression algorithm, extending pulse oximetry into automated recognition of clinically important physiological patterns.
Medical Devices & Diagnostics
FDA approves Genentech’s ENSPRYNG as first at-home treatment for thyroid eye disease
The FDA has approved satralizumab for adults with thyroid eye disease, introducing the first at-home subcutaneous treatment option. The decision follows two Phase 3 trials, one of which missed its primary endpoint, while the other demonstrated significant improvements in eye bulging and double vision.
Medical Devices & Diagnostics
Organon reports 3.9% six-year pregnancy rate with hormone-free MIUDELLA IUD
Organon has reported a cumulative six-year Pearl Index of 0.93 and an estimated pregnancy rate of 3.9% for the hormone-free MIUDELLA intrauterine system. The findings support an FDA application to extend its approved use from three to six years, with a decision expected in the second quarter of 2027.