Latest Medical Devices News

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.

Orthocell’s nerve repair device Remplir is being adopted in Australia for nerve-sparing prostate cancer surgeries, aiming to reduce erectile dysfunction and urinary incontinence post-operation. This development could significantly expand Remplir’s market reach globally.

Adherium Limited’s iCARE study reports unprecedented medication adherence improvements and sustained patient engagement in COPD and asthma care, highlighting significant clinical and economic benefits.

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.

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.

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.

Orthocell Limited reports an 81.1% overall treatment success rate from its Remplir Real World Evidence study, reinforcing the product’s safety and efficacy as it expands sales in the US and prepares regulatory submissions for the EU and UK.

Memphasys has inked a five-year exclusive distribution agreement with Middle East leader ITL, unlocking a $325,000 initial order for its Felix™ fertility system upon CE Mark approval. This deal opens access to 15 countries and over 350 IVF clinics, setting the stage for rapid regional adoption.

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.