Medical Devices & Technology

SHERIDAN, WYOMING - April 12, 2026 - ABK Biomedical has completed enrollment of all 120 patients in ROUTE90, its pivotal U.S. FDA Investigational Device Exemption study evaluating Eye90 microspheres® for unresectable hepatocellular carcinoma (HCC), the most common form of primary liver cancer. The milestone positions the Halifax-based medical device company to finalize one-year patient follow-up, then submit a Premarket Approval (PMA) application to the FDA. Eye90 microspheres hold FDA Breakthrough Device Designation, signaling regulatory recognition of the device's potential to address an unmet clinical need in liver cancer care.

WASHINGTON, 4 March 2026: AdvaMed said the U.S. Senate has approved legislation to reauthorize the federal Small Business Innovation Research and Small Business Technology Transfer programs, and the association called on the House of Representatives to move quickly on passage. The medtech trade group said the vote matters because authorization for the two programs lapsed on 30 September 2025, leaving early-stage medical technology companies without the certainty they need as they pursue product research and development.

SHERIDAN, WYOMING - April 03, 2026 - Perimeter Medical Imaging AI has secured FDA premarket approval (PMA) for Claire, making it the first AI-enabled imaging device cleared in the United States for intraoperative breast cancer margin assessment during lumpectomy procedures. Claire, previously marketed as the Perimeter OCT B-Series with ImgAssist AI 2.0, holds FDA Breakthrough Device designation and targets an estimated 300,000 annual U.S. breast-conserving surgeries where residual disease forces re-operations in roughly one in five cases. The approval positions Perimeter to launch a nationwide commercial rollout in the weeks following clearance, converting a clinical trial asset into a revenue-generating platform with expansion potential across additional cancer indications.

SHERIDAN, WYOMING - March 31, 2026 - Climate resilience planning is moving into 2026 healthcare procurement, regulatory, and supply-chain decisions as the European Commission develops an Integrated Climate Resilience Framework that could shape how medical technology manufacturers invest, document compliance, and maintain uninterrupted access to devices and diagnostics. In February 2026, MedTech Europe responded to the Commission's public consultation and argued for a holistic healthcare system response built on smart investments, better coordination, consistent policy frameworks, and improved collaboration across healthcare actors.

SHERIDAN, WYOMING - March 31, 2026 - Medical device companies assessing 2026 market access, compliance planning and regional expansion in the Middle East and Africa face a more policy-driven environment, as trade associations use WHX Dubai 2026 to shape discussion on regulatory frameworks, international alignment and patient access. MedTech Europe said it will be present at WHX Dubai 2026, formerly Arab Health, to engage policymakers, regulators and other stakeholders from across the Middle East, Africa and beyond on issues affecting the medical technology sector, with attention on how medical technologies can support patient access and resilient health systems across regions.

SHERIDAN, WYOMING - March 31, 2026 - Early-stage medtech companies could regain a key non-dilutive funding route in 2026 after the Senate passed legislation to reauthorize the federal Small Business Innovation Research and Small Business Technology Transfer programs, reducing uncertainty that has persisted since the programs' authorization lapsed on September 30, 2025. AdvaMed said the Senate action restores momentum for grants that support early research and development at startups and small manufacturers, and it urged the House of Representatives to move quickly on passage. The association framed the programs as an important bridge for companies that struggle to finance next-generation device development before products reach patients or later-stage commercial milestones.

SHERIDAN, WYOMING - March 31, 2026 - Medtech companies planning 2026 leadership recognition, industry positioning, and internal talent visibility now have a defined nomination window tied to one of the sector's highest-profile annual gatherings. AdvaMed has opened nominations through April 10 for three 2026 honors: the AdvaMed Lifetime Achievement Award, the AdvaMedDx Lifetime of Leadership & Service Award, and the AdvaMed Imaging Röntgen Award. All three awards are scheduled to be presented at The MedTech Conference, set for October 18-21, 2026, in Boston.

SHERIDAN, WYOMING - March 23, 2026 - Medical device procurement, market-entry, and sourcing decisions for 2026 shift as the EU-India Free Trade Agreement moves from negotiation to implementation, reducing tariff friction on most EU-made devices entering India and putting more weight on customs, conformity assessment, and regulatory execution. The agreement carries direct implications for patient access, market access, and competitiveness in the medical technology sector. For EU manufacturers and Indian buyers, the practical change is that a major cost barrier on cross-border device trade is set to ease while compliance and trade processes become a more important part of operational planning.

SHERIDAN, WYOMING - March 23, 2026 - Medical-device manufacturers, regulatory teams and healthcare procurement planners in Europe face a sharper 2026 focus on policy direction, oversight and innovation priorities as the European Commission convenes a high-level conference to assess recent sector developments and discuss what comes next. The meeting is scheduled for 16 March 2026 in Brussels and brings together Commissioner for Health Olivér Várhelyi, representatives from EU regulatory authorities, the Council, the European Parliament and experts from EU stakeholders' associations. The stated purpose is to take stock of recent key developments in the medical-devices sector and provide a view of the future, making the conference a concentrated signal of where policy and industry dialogue are heading within the EU framework.

SHERIDAN, WYOMING - March 09, 2026 - MedTech Europe participated in the first in‑person meeting of the HERA Industrial Cooperation Forum on 6 February 2026, a session in which the European Commission presented HERA's annual workplan and launched two technical working groups. The association used the meeting to underline the operational importance of medical technologies in health responses and to press for practical industry involvement in preparedness exercises. MedTech Europe also flagged the potential burden from additional reporting requirements and said forthcoming work will focus on supply‑chain risks and on supporting development, manufacturing, availability and accessibility of medical countermeasures.