Shots:
The US FDA has granted clearance to Cala kIQ Plus system, a wearable neurostimulation device, for the treatment of action hand tremor in essential tremor (ET) & Parkinson's disease (PD)
The Cala kIQ device provides temporary relief of hand tremors in adults with essential tremor & Parkinson’s disease, incl. postural & kinetic tremors, using transcutaneous…
Shots:
The US FDA has granted 510(k) clearance to Miracell’s SMART M-CELL PRP Concentration System and Bone Marrow Concentration System, including associated blood and bone marrow kits
Clearance was based on substantial equivalence to SmartPReP, with the system demonstrating high cell viability, efficient growth factor extraction, and integrated performance across centrifuge and kit components
SMART…
Shots:
The US FDA has granted clearance to Elitone for Men to help restore bladder control after prostate surgery, with US availability expected in Apr 2026
Elitone for Men is a non-invasive, at-home therapy that delivers neuromuscular stimulation to strengthen pelvic floor muscles, improving bladder control, with a simple 20min. daily use enabling consistent treatment…
Shots:
The US FDA has cleared all QIAstat-Dx GI Panels for use on the QIAstat-Dx Rise automated syndromic testing system
The clearance enables laboratories to run both GI and respiratory panels on the high-throughput platform, which can process up to 160 tests/day, run 16 samples per batch, and deliver results in ~1hr. using real-time PCR…

