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.
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.
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The US FDA has published a draft guidance on clinical performance testing and evaluation for premarket submissions from manufacturers of cuffless blood pressure measuring monitors, which the agency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.
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.
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.
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.
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.
Abbott’s newly CE-marked TactiFlex Duo dual-ablation catheter used for treating AFib is competing against products already introduced by Boston Scientific, J&J and Medtronic.
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.
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.
The US FDA has sent warning letters to four companies that it says distribute HIV sample collection kits for home use without proper regulatory authorization.
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.
Boston Scientific’s $14.5bn Deal Folds Penumbra Thrombectomy Platforms Into Cardiovascular Franchise
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.
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.
In this first roundup from CES, Medtech Insight shines a light on AI-powered technologies that help the aging population live healthier and stay independent longer.
Johnson & Johnson is seeking marketing authorization from the US FDA for its Ottava surgical robot for upper abdomen procedures. If granted, Ottava could prove stiff competition for Medtronic and Intuitive.
The MAGiC catheter works with Stereotaxis’ robotic magnetic navigation technology, which allows physicians to steer catheters through the heart with precision and stability.