Device Area
Cerenovus is recalling multiple products from its Cerepak Uniform, Cerepak Heliform and Cerepak Freeform product lines due to a higher-than-expected failure to detach rate. While customers were sent a safety alert in October, the US FDA announced the recall on Feb. 5.
Women’s health start-up Midi Health has raised $100m in a Series D financing, led by Goodwater Capital with new investors Foresite Capital and Serena Ventures. Midi, which focuses on women in midlife, said the money will support the next phase of growth.
The US FDA has warned that Magellan Diagnostics blood lead tests may provide inaccurately high results, particularly with tubes from ASP Global. Magellan’s tests had previously been recalled over inaccurate low results. The FDA also issued warning letters to both firms.
Stryker’s broader orthopedics portfolio continued to benefit from strong robotic demand during the quarter, with the company reporting 28.7% organic growth in its US Orthopedics other than hips and knees business.
Medtronic has agreed to acquire Cathworks for up to $585m, converting a long-standing partnership into full ownership as it expands its footprint in coronary physiology and AI-enabled cardiovascular tools.
The US FDA says Abiomed has reported 22 serious injuries linked to an issue with some of its temporary heart pumps that provide support to patients with acute right heart failure.
INBRAIN unveiled a bidirectional "rice-sized" BCI chip partnership, Merck commercialization progress and new speech-decoding trial in France as it advances its graphene-based cortical interface toward commercialization, pending regulatory clearance.
Medtech Insight was invited to moderate a panel discussion with leading experts in neuroscience and AI during INBRAIN’s five-year anniversary in Barcelona, Spain. Panelists discussed the promises, perils in BCI development, neuroethics and outlook.
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.