Device Area

The US FDA has granted clearance to eMurmur, broadening the use of its AI-powered software platform. The innovative system identifies primary heart sounds to detect abnormal murmurs as they occur.

The US FDA has published a draft guidance on clinical performance testing and evaluation for premarket submissions from manufacturers of cuffless blood pressure measuring monitors, which the agency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

Abbott started 2026 as it ended 2025 – with major regulatory breakthroughs for pulsed field ablation innovations, boosting its EP credentials in the US and EU. It also broadened its IVDs platform by adding cancer detection and screening company Exact Sciences in a deal expected to close in Q2.

Subject to shareholder approval,Boston Scientific will acquire Penumbra for approximately $11bn in cash on hand and new debt, and issue 41 million shares for the remaining $4bn.

Medtech Insight spoke with Rambam Medical Center’s Michael Mimouni, who implanted the first 3D-bioprinted corneal graft in a human patient, about his hopes for Precise Bio’s approach. The patient is part of a Phase I trial evaluating PB-001 in patients with corneal edema.

Roche Diagnostics, Intuitive Surgical, Abbott and Edwards Lifesciences all acknowledge tariff headwinds, but stress preparedness, resilience and mitigation. Below is look at how management framed the impact in Q1 vs Q2 earnings calls.

Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

BioStem Technologies’ buyout of BioTissue Holding’s surgical and wound-care business adds cryopreserved and sterile technologies, Cryotek and SteriTek, and a direct sales force focused on acute care settings.

ces 2026

Withings announced at CES that its health monitoring app will integrate data from Abbott’s OTC CGM Lingo starting in Q1.

Timed to debut during this week’s CES 2026 technology conference in Las Vegas, the new feature within Abbott’s Libre glucose monitoring software uses generative artificial intelligence to predict how food choices may affect glucose levels.

perspectives 2026

Last year was a busy one for the medtech industry, with major advances in technology as well as big changes at regulatory agencies. Get a peek at the stories our readers couldn't miss.

The US FDA has granted clearance to eMurmur, broadening the use of its AI-powered software platform. The innovative system identifies primary heart sounds to detect abnormal murmurs as they occur.

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.

Abbott started 2026 as it ended 2025 – with major regulatory breakthroughs for pulsed field ablation innovations, boosting its EP credentials in the US and EU. It also broadened its IVDs platform by adding cancer detection and screening company Exact Sciences in a deal expected to close in Q2.

The US FDA has issued an early alert concerning some Axios stent and delivery systems used in endoscopic drainage procedures after receiving reports of serious injuries and deaths linked to the device.

Last year was a busy one for the medtech industry, with major advances in technology as well as big changes at regulatory agencies. Get a peek at the stories our readers couldn't miss.

Shantanu Gaur, CEO of Allurion Technologies, a company that has developed a swallowable gastric balloon, believes that GLP-1 sales could indirectly lead to increased demand for medical device-based bariatric procedures, especially as patients seek alternatives to drug side effects and weight regain.

The US FDA says Olympus has updated its instructions for a device used in many endoscopic procedures after reports of serious injuries. The class I recall follows the FDA blocking imports of other scoping devices from the Japanese firm earlier this year.

In this final part of a three-part series, Medtech Insight spoke with a neuroethicist and the first person in a trial using a BCI implant for stimulating hand movement. This story explores ethical considerations that arise when projects can no longer support patients with implanted devices.

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

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.

MIT-scientist turned entrepreneur Christin Glorioso founded start-up NeuroAge Therapeutics to reverse brain aging and fight dementia.