MedTech News

Dean Kamen, insulin pump pioneer, wants to shake up diabetes tech
Kamen and Sequel Medtech CEO Alan Lotvin say they are offering greater precision in insulin delivery with new pump technology in the Twiist device.

SONOMOTION ANNOUNCES FDA DE NOVO CLEARANCE FOR ITS STONE CLEAR™ DEVICE
SAN MATEO, Calif., Nov. 13, 2024 /PRNewswire/ — SonoMotion, a medical device company developing non-invasive solutions for kidney stones, announced today that the FDA has granted de novo clearance for the Company’s Stone Clear™ device for the anesthesia-free treatment of post-lithotripsy kidney stone fragments.

SmartCardia Receives FDA Clearance for Outpatient Cardiac Telemetry for Its 7-Lead ECG Patch and Cloud Platform
LAUSANNE, Switzerland, Nov. 13, 2024 /PRNewswire/ — SmartCardia has received FDA clearance for Mobile Outpatient Cardiac Telemetry (OCT/MCT) for its 7-lead live ECG monitoring patch and cloud platform. SmartCardia’s 7L patch is easy-to-wear, cable-free, waterproof and can be used for continuous monitoring for up to 14 days

Johnson & Johnson wins FDA IDE for Ottava surgical robot
Johnson & Johnson MedTech announced today that the FDA granted its Ottava surgical robot investigational device exemption (IDE).

Nevro wins CE mark for HFX iQ spinal cord stim for pain relief
Nevro (NYSE:NVRO) announced today that it received CE mark in Europe for its HFX iQ spinal cord stimulation (SCS) system.

Magstim earns FDA clearance for transcranial magnetic stimulation that treats depression, OCD
Magstim announced today that the FDA cleared its next-generation Horizon Inspire system for delivering transcranial magnetic stimulation (TMS).

FDA clears AI-powered breast cancer detection tech from iCad
iCad (Nasdaq:ICAD) announced today that the FDA cleared its ProFound Detection version 4.0 for digital breast tomosynthesis (DBT).

Philips wins FDA clearance for new detector-based radiotherapy system
Philips (NYSE:PHG) announced today that the FDA granted 510(k) clearance for its new detector-based spectral computed tomography (CT) radiotherapy solution.