Latest Medical Devices News

4DMedical has gained Canadian regulatory approval for its innovative CT – VQ™ ventilation-perfusion imaging technology, enabling immediate commercial rollout through Philips and expanding its North American footprint.

Orthocell has lodged a regulatory application to distribute its nerve repair product Remplir™ across the EU and UK, aiming to tap into a $750 million market with approval expected by Q3 2026.

Echo IQ has formally lodged its FDA 510(k) submission for EchoSolv HF, an AI-driven heart failure diagnostic software validated by Mayo Clinic data, aiming to tap into a $60 billion US market.

EBR Systems has completed the first patient implant in its Totally Leadless CRT (TLC-AU) feasibility study, marking a strategic step toward expanding wireless cardiac resynchronisation therapy for heart failure patients.

EBR Systems has expanded its intellectual property holdings with four new patents, reinforcing its lead in wireless cardiac pacing technology, while facing a preliminary setback on a patent term extension application.

Anteris Technologies has secured regulatory green lights for its pivotal PARADIGM trial and raised $25.2 million in capital, advancing its innovative DurAVR® transcatheter heart valve towards commercialisation.

BTC Health has reissued its Chairman’s Address with added financial details, highlighting a strategic shift towards diversified medical products and a strong start to FY26 with 36% revenue growth.

Control Bionics Limited is set to acquire the remaining stake in Neuro Elite Athletics, integrating the NeuroBounce athletic performance program with its EMG technology to accelerate growth in key markets.

Vitasora Health has secured AU$3.56 million from a cornerstone investor, issuing over 118 million shares, while confirming compliance with key regulatory disclosure obligations.

Control Bionics has secured $3.25 million through a discounted share placement, aiming to boost its assistive and neurotechnology product growth globally.

BTC Health has broadened its medical product portfolio through strategic acquisitions and organic growth, reporting strong early revenue gains while cautiously navigating the uncertain timing of ECMO system adoption.

Singular Health has submitted a 510(k) premarket notification to the FDA for its enhanced 3DICOM MD Cloud platform, aiming to expand imaging capabilities and introduce a scalable, cloud-native solution for medical image management.