Marine Biomedical, a strategic partner of Orthocell, has received US Food and Drug Administration (FDA) 510(k) clearance for PearlBone, a bone graft substitute made from pearl shell sourced sustainably from Western Australia's Kimberley region. The FDA clearance allows PearlBone to be marketed in the United States for its intended indications, marking a significant milestone for both companies as they aim to enter one of the world's largest medical device markets. Orthocell, an Australian biotech company listed on the ASX (ASX:OCC), finalized a strategic investment in Marine Biomedical in January 2026, increasing its equity stake to 12% through a $1.05 million investment. This investment also secured Orthocell a first right of refusal over global distribution rights for PearlBone and future bone repair and regeneration products. PearlBone leverages the natural properties of nacre, the biomineralized structure of pearl shell, to support bone repair and regeneration. The product is manufactured at Marine Biomedical's purpose-built facility in Broome, Western Australia, which supports the development of advanced biomedical manufacturing capabilities in regional Australia. Orthocell's CEO, John Van Der Wielen, stated that the FDA clearance represents a significant step toward unlocking the potential of PearlBone in the global bone repair and regeneration market. He emphasized that the investment was made with the strategic objective of securing exposure to innovative bone regeneration technology that complements Orthocell's existing nerve and tendon repair portfolio. Marine Biomedical is now advancing preparations for the US launch, including manufacturing readiness, market development, and engagement with potential commercial and clinical partners. The clearance enables Orthocell to leverage its established relationships with US surgeons, distributors, and commercial infrastructure to support PearlBone's market introduction. PearlBone has potential applications across orthopedic, trauma, and reconstructive surgery, positioning it for broad market adoption. This development follows Orthocell's recent success in recording its strongest monthly US Remplir sales since launch, indicating growing market acceptance for its products in the United States.

HighlightsDefinitive exclusive distribution agreement with SPORTORO d.o.o. for Croatia, Serbia and Bosnia and Herzegovina.Commercial scope covers VIVI Cap™, VIVI Epi™ and VIVI Med™, extending access across insulin pens, epinephrine auto-injectors, vials and other compatible temperature-sensitive medication formats.The agreement contemplates the initial order is to be placed and fully paid in accordance with the agreement, with the second targeted within six months.At exact minimum unit targets...

Many of the most significant challenges in Medical Device Development come down to how we best manage uncertainty. We have a clear picture of what we’re aiming for, namely an approved and adopted device that is demonstrably safe and effective and is used and reimbursed within our target healthcare m

Vancouver, British Columbia and Casablanca, Morocco--(Newsfile Corp. - October 6, 2026) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic", or the "Company"), a medical device company commercializing IzoView, a dedicated breast CT imaging system for the more accurate screening and diagnosis of breast cancers, announces that further to its September 25th announcement it has completed a non-brokered private placement financing (the "Offering"), whereby the Company issued...

Vancouver, British Columbia and Casablanca, Morocco--(Newsfile Corp. - September 25, 2026) - Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) ("Izotropic", or the "Company"), a medical device company commercializing IzoView, a dedicated breast CT imaging system for the more accurate screening and diagnosis of breast cancers, announces the intention to complete a non-brokered private placement (the "Offering") with of 750,000 units of the Company with a strategic investor, (each a...

The nature of medical device or combination product development is that many projects, at one point or another, are likely to engage external support - in the form of medical device consulting. This is true from the largest pharma to the smallest startup, and is due to the high complexity, large bre

Helpful guidance addressing the clinical evaluation of medical devices is difficult to come by. This is because, unlike, for example, the Regulatory space, there is a dearth of published guidance, standards, and expectations to help medical device and combination product developers navigate the expe

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TL;DR CISA disclosed eight vulnerabilities in the Mira Hormone Monitor and its Android app. The worst, CVE-2026-68067, scores a critical CVSS 9.8. It lets a remote attacker control user accounts by bypassing the cloud login entirely. No public exploitation has been confirmed. Why it matters The Mira monitor tracks hormone levels for fertility planning. So its data is deeply personal. An attacker who can control user accounts gains…