Latest Medical Devices News

Cardiex Limited has commenced U.S. deliveries of its CONNEQT Pulse arterial health monitor alongside the launch of its companion CONNEQT App, marking a pivotal expansion into the American digital health market.

Hydrix Limited has extended its contract with Paul Hartmann AG, adding $2.8 million in revenue and reinforcing its international growth strategy.

Imricor Medical Systems reports strong Q4 CY24 progress with successful FDA review, CE Mark submissions, and an 840% jump in consumables revenue, positioning the company for expanded global market penetration.

Compumedics has locked in a pivotal five-year contract with Philips Australia, cementing Somfit as the leading device for pharmacy-based sleep testing and underpinning significant SaaS revenue growth through 2028.

PolyNovo Limited reports a robust 22.8% revenue increase in 1H FY25, driven by strong U.S. and international sales growth and progressing FDA approval efforts for its NovoSorb platform.

Visioneering Technologies reports promising interim results from its PROTECT trial, showing significant control of myopia progression in children using NaturalVue® Multifocal lenses.

Orthocell Limited has reported a third consecutive quarter of record revenue, driven by strong sales growth and strategic market expansions, including a key US FDA submission for its nerve repair product Remplir™.

EBR Systems has announced a rescheduling of the FDA Pre-Approval Inspection for its wireless cardiac pacing device to January 14, 2025, while maintaining its regulatory approval timeline for Q1 2025 and a commercial launch later in the year.

EBR Systems Inc. has responded to ASX's price query, denying any undisclosed information behind recent trading spikes and confirming compliance with listing rules. The company also flagged an upcoming FDA inspection announcement.