Latest News

Microbot’s chairman and CEO Harel Gadot revealed that the company has been developing its ‘commercial readiness’ strategy since Q2 2025. Credit: Tada Images / Shutterstock.com

The US Food and Drug Administration (FDA) has cleared Microbot’s LIBERTY, a single-use, remotely operated robotic system for peripheral endovascular procedures.

Microbot completed the ACCESS-BVI pivotal trial (NCT06141694) for its system in April 2025. Meeting the primary and secondary endpoints, the study demonstrated a 100% success rate in the robotic navigation to target with zero device-related adverse events (AEs) through the three-day follow-up period.

Microbot’s chairman and CEO Harel Gadot revealed that the company has been developing its ‘commercial readiness’ strategy since Q2 2025 and is now ‘well-positioned’ to accelerate its market entry.

Gadot said: “With FDA clearance, we can now complete the final commercial activities that were contingent on marketing clearance, positioning us to commence commercialisation, penetrate the approximately 2.5 million annual US peripheral vascular procedures, and pursue entry into global markets.” 

A new report by MedTech Europe indicates that Europe’s medical technology sector is continuing to innovate and grow in economic strength.

The trade body’s report revealed that Europe’s overall medical technology market was worth around €170bn ($198.6bn) in 2024, with the sector employing over 930,000 staff.

Germany represents the biggest EU market with a 25% market share, followed by France, the UK, Italy, and Spain in positions 2-4, respectively.

According to MedTech Europe, digital health is rapidly scaling in Europe as a result of the convergence between breakthrough technologies, patient empowerment, and systemic efficiencies.

The assertion reflects that this charge is being spearheaded by Germany and France due to the nation’s expanded access to digital health through established reimbursement frameworks.

Germany’s DiGA (Digital Health Applications) pathway to date includes reimbursement for 59 DiGA solutions, with the country having now reached one million DiGA prescriptions issued since the pathway’s launch in 2020. 

More than 1,000 staff at the US Department of Health and Human Services (HHS) have signed an open letter calling on Robert F Kennedy Junior (RFK) Jr to resign from his post amid claims the health secretary is “endangering the nation’s health”.

The 3 September letter highlights numerous actions that RFK Jr has taken since being sworn in as health secretary in February 2025.

Grievances include RFK Jr’s “refusal” to be briefed by experts from the Centers for Disease Control and Prevention (CDC) on vaccine-preventable diseases and his decision to rescind the US Food and Drug Administration’s (FDA) emergency use authorisations for Covid-19 vaccines “without providing the data or methods” used to reach such decision. 

The letter read: “Under Secretary Kennedy’s leadership, HHS policies are placing the health of all Americans at risk, regardless of their politics.

“[…] We warn the President, Congress, and the Public that Secretary Kennedy’s actions are compromising the health of this nation, and we demand Secretary Kennedy’s resignation.”

STAAR Surgical’s largest shareholder has said it plans to vote against Alcon’s proposed $1.5bn takeover of the ailing eye specialist.

Broadwood Partners, which owns 27.3% of STAAR’s common shares, said the transaction, announced last month, suffered from “multiple process and valuation deficiencies”.

The investment firm expressed disappointment over the actions of STAAR’s board, claiming it had failed to pursue an “adequate” sale process. According to Broadwood, STAAR’s board also displayed “intransigence” in relation to Broadwood’s books and record demand, stating it had received no documents since making the request more than three weeks ago.

STAAR’s Q1 2025 financials revealed a 45% decline in sales to $42.6m, down from $77.4m in Q1 2024, with the US-based company chiefly attributing the sharp decline to weakened demand in China and additional headwinds due to government initiatives in the country affecting device procurement. 

The Advanced Medical Technology Association (AdvaMed) has called on the US Centers for Medicare & Medicaid Services (CMS) to address “serious flaws” in the health agency’s proposed rule to restart the competitive bidding programme (CBP) for certain devices in Medicare. 

The proposed rule would target durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). The CBP for DMEPOS is a system by which suppliers compete to offer medical equipment at the lowest cost to Medicare. In December 2023, the programme was paused due to feasibility issues after the Covid-19 pandemic and because of industry pushback over claims that the CBP was driving prices too low. 

In June, the CMS outlined a proposed rule to restart the CBP. The agency said the action, mooted for implementation by 2027, would function as a tool to remove fraudulent DME suppliers from the Medicare programme and reduce Medicare expenditures on the device category.