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Molecular diagnostics firm SAGA Diagnostics has introduced a colorectal cancer test that can detect even very low levels of cancer biomarkers. The test helps clinicians guide post-surgical treatment decisions.

The US FDA has published a draft guidance on clinical performance testing and evaluation for premarket submissions from manufacturers of cuffless blood pressure measuring monitors, which the agency generally regulates as class II devices.

The electrostimulation pain treatment firm reportedly shipped excessive supplies to patients for eight years, driving up revenues as well as stock prices.

AI promises to be the much-needed solution to the now overly complex field of EU medtech regulatory affairs. Will every stakeholder start using solutions such as Raiana?

As the deadline for the US FDA’s new quality system incorporating international standards fast approaches, the agency held a town hall to offer industry some last-minute tips to get ready for the regulatory framework.

The FDA has cleared Intuitive Surgical’s da Vinci 5 for some cardiac procedures, opening new opportunities for the firm. The company is also looking to expand its presence in ambulatory surgical centers, execs said during a Jan. 22 earnings call.

In an era of AI and other advanced computing methods, pure-play mechanical devices could offer better pricing and practicality, according to the CEO of prosthetics company Metacarpal.

Atul Gupta, MD and CMO of Royal Philips’ Diagnosis & Treatment business, shares his views about potential developments in imaging and wider medtech in 2026 and the value of AI. He warns that clinicians will not adopt AI they don’t trust, understand or find helpful in real-world conditions.

After receiving the FDA nod for the first in-ear EEG device for brain monitoring, Noax plans four clinical trials in the US focused on epilepsy and is looking for audio company partners to integrate the same tech for use by consumers to monitor their brain activity, the company told Medtech Insight.

GE HealthCare CEO Arduini believes the imaging market is large enough to accommodate multiple players as adoption progresses, describing photon-counting CT as a long-cycle transition rather than a near-term shift.

While several competitors are developing or launching patch pumps, Insulet CEO McEvoy described Omnipod as differentiated by both technology and manufacturing scale. She said the company has invested roughly $3bn across R&D and manufacturing.

Amid the spectacle of humanoid robots at CES 2026, Swedish medical simulation company Surgical Science opted for a quieter pitch for its suitcase-sized robotic surgery simulator aimed at taking training out of the OR.