MedTech News
.................... by Andrew Celentano

Brain-controlled hearing system isolates one speaker in noisy settings, first human tests show
Scientists at Columbia University’s Zuckerman Institute have the first direct evidence from human studies that brain-controlled hearing technology can help people single out a voice in a crowd

Diabeloop gets CE mark for next-gen algorithm paired with Dexcom G7, ViCentra Kaleido
Diabeloop announced today that it received CE mark approval for its latest automated insulin delivery (AID) platform, DBLG2.

Corvention earns FDA clearance for aortic valve balloon catheter
Corvention announced today that it received FDA 510(k) clearance for its KardiaPSI balloon catheter device.

Biozen Receives FDA Clearance for Calibration-Free Cuffless Blood Pressure Technology
Handheld fingertip device delivers clinical-grade readings — no cuff, no calibration, no compromise.

Wenda Pharma’s NHWD-870 Receives China Breakthrough Therapy Designation for NUT Carcinoma
The NMPA designation advances NHWD-870 HCI, an oral BET inhibitor for advanced thoracic NUT carcinoma, following Phase II data showing anti-tumour activity and survival benefit in a rare, aggressive cancer with limited treatment options.

Ultrasensitive test detects biomarkers for specific form of dementia
Investigators from Mass General Brigham have developed an ultrasensitive test capable of detecting abnormal clumps of a protein called TDP-43, which defines a specific subtype of FTLD pathology called FTLD-TDP.

AI-powered electrocardiogram detects early signs of heart failure
Interpreting relatively inexpensive electrocardiograms (ECGs) with an artificial intelligence (AI) algorithm accurately screened patients for a key precursor of heart failure in Kenya.

Brain imaging reveals migraine headache subtypes
They’ve been described as “brain on fire” or “an ice pick through the head.” Migraine headaches affect more than one in 10 Americans, and they’re so much worse than a regular headache.