Regulatory Approvals

Masimo (NASDAQ: MASI) announced that the Rad-G® with Temperature has received FDA 510(k) clearance. Rad-G with Temperature is a rugged, versatile, handheld monitor that provides clinically...

Moon Surgical has announced that its Maestro System is now CE Marked under the Medical Device Regulation (EU) 2017/745. “This new milestone is a testament to...

Avation Medical, Inc., the innovator in patient-friendly, closed-loop neuromodulation options to treat life-altering medical conditions, announced that its Vivally System received US Food...

Medical practitioners can use the device to detect difficult-to-identify heart anomalies such as atrial fibrillation. Canadian medical technology company Icentia has secured 510(k) clearance from...

Axiom PSR is said to be the first all-metal, patient-specific instrument approved for use with an ankle arthroplasty system. Medical device firm restor3d has received...

Synapse Biomedical announced that the FDA granted premarket approval (PMA) to its NeuRx diaphragm pacing system (DPS). Oberlin, Ohio-based Synapse designed NeuRx DPS for patients with...

New Auto B-line Counter uses deep learning technology with the aim of empowering providers to assess abnormal lung conditions easier, faster, and with more...

The company recently concluded implantation of the Prima System in patients in the European PRIMAvera pivotal study. Bioelectronics company Pixium Vision has received breakthrough device designation...

FemDx Receives FDA Clearance for Its FalloView Falloposcope The device is the first totally disposable 1.2mm diameter falloposcope incorporating a CMOS chip endoscope. FemDx Medsystems, a...