Latest Medical Devices News

Imricor Medical Systems has successfully completed a comprehensive Human Factors study for all its devices under FDA review, marking a critical milestone towards U.S. market entry. The extensive 7-month study involved 46 healthcare professionals and tested nine products, underscoring Imricor’s growing momentum in electrophysiology innovation.

EMVision Medical Devices has raised $12 million through a placement backed by institutional investors, including strategic partner Keysight Technologies, and launched a Share Purchase Plan to raise up to $2 million from existing shareholders. The capital will support key clinical and regulatory milestones for its neurodiagnostic devices over the next two years.

EBR Systems has achieved a significant commercial milestone with its tenth US implant of the WiSE wireless cardiac pacing system, setting the stage for broader market adoption supported by new reimbursement schemes.

AVITA Medical has secured the CE Mark for its innovative RECELL GO device, paving the way for commercialization across key European markets including Germany, Italy, and the UK. This regulatory milestone expands the company’s footprint in acute wound care.

Control Bionics Limited has confirmed its compliance with ASX continuous disclosure rules following an inquiry about the timing and content of its financial results announcements.

PolyNovo’s NovoSorb BTM, combined with negative pressure wound therapy, significantly accelerates healing of large post-surgical diabetic foot wounds, according to new clinical trial data.

Ansell Limited has updated its FY25 final dividend announcement, confirming the dividend amount, exchange rate, and Dividend Reinvestment Plan pricing, providing clarity for shareholders ahead of payment.

dorsaVi has inked a five-year sales agreement with Select Medical, opening access to over 1,900 US outpatient physical therapy centers for its FDA-approved motion analysis products. This follows a successful 18-month pilot validating clinical benefits in athlete rehabilitation.

Compumedics has secured FDA clearance for its single-use Somfit®D device, effectively doubling its addressable U.S. home sleep testing market to an estimated US$240 million annually. This milestone positions the company to capture significant market share with a dual-platform EEG-based solution.

Control Bionics Limited has announced a 1-for-5 non-renounceable rights issue to raise up to $2.06 million, aiming to fund the commercial expansion of its NeuroStrip® device and operational growth. The offer is partially underwritten and open to eligible shareholders in Australia and New Zealand.

Lumos Diagnostics has secured a significant follow-on contract with Aptatek Biosciences to push forward the development of an innovative in-home monitoring device for Phenylketonuria (PKU), a rare genetic disorder. This next phase aims to bring the FDA Breakthrough Device-designated PheCheck™ closer to clinical trials and commercial readiness.

Imricor Medical Systems has taken a significant step toward U.S. market entry by submitting its Vision-MR Diagnostic Catheter for FDA 510(k) approval, complementing its recent NorthStar system filing. These moves aim to establish a fully integrated MRI-guided cardiac ablation platform.