Device Area
Abbott presented late-breaking data at the 2025 American College of Cardiology conference demonstrating that TriClip transcatheter edge-to-edge repair offers prolonged patient benefits compared to medical treatment alone after two years, which were not evident at one year.
The Cologuard Plus test has a sensitivity of 95% and a specificity of 94% for the detection of colorectal cancer; “unmatched accuracy,” according to Exact Sciences.
The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.
A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.
Vektor Medical is ramping up efforts to bring its vMap technology used to identify arrhythmia sources to more US hospitals, start enrollment in a multinational trial, and commercialize in Europe, pending the CE mark. Medtech Insight sat down with CEO Rob Krummen at LSI 2025 to discuss their plans.
Only 16% of venture capital general partners in Europe are women, and only 9% of those have actual investment power. Thena Capital is aiming to "redefine the image of a venture capitalist."
Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.
Early diagnosis can be “detrimental” to patients, Suzanne O'Sullivan, neurologist and author of “The Age of Diagnosis,” argued at the Wired Health conference on 18 March. "You save one life from screening 2,000 women for breast cancer, but you also treat 10 women unnecessarily," she said.
Medtech Insight sat down with Intuitive Surgical CEO Gary Guthart at the recent LSI USA conference to discuss the full launch of the new da Vinci 5 robotic system and planned digital enhancements. Guthart also offered his views on health care interoperability, AI regulation, outpatient surgeries, autonomous robots, and how the company is harnessing technology to shape the future of robotic surgery.
People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.
Cambridge, UK-based breath biopsy company Owlstone Medical will apply its volatile organic compound analysis platform in an attempt to develop a test for the identification and monitoring of pseudomonas aeruginosa in patients with cystic fibrosis.
The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.
The urine-based GAGome test showed promise in the first clinical results from the international AURORAX-0087A, in the largest study conducted on clear cell renal cell carcinoma, the most common type of kidney cancer.
Roche Diagnostics CEO Matthew Sause tells Medtech Insight about how the technology addresses the pricing challenges for mid- and low-throughput customers.
A new set of clinical lab regulations, which came into effect in January, include higher fees, an expanded set of possible consequences for labs that are not in compliance, and revised employee standards.
23andMe has filed for Chapter 11 bankruptcy and announced the resignation of founder and CEO Anne Wojcicki. Privacy concerns surrounding the sale of its extensive genetic database remain after a 2023 data breach exposed data from some 7 million users. Experts warn that bankruptcy proceedings could lead to consumer data being sold, raising questions about legal protections and consumer rights.
With the support of AIM-MASH AI Assist only one pathologist is needed to reliably make a histology assessment of inflammatory liver disease to decide whether patients should be included in MASH clinical trials.
Barcelona-based accelerator S2 Xpeed is driving the rapid growth of medtech and hardware start-ups in Europe. Operating under a "sweat equity" model, the program helps early-stage companies move from prototype to manufacturing readiness in exchange for equity. This month, the accelerator will add a fourth cohort of 10 more start-ups, five of which are in the medtech space.
The US FDA has issued an early alert about the CVAC system from Calyxo, which urologists use in removing urinary stones.
Medtech Insight sat down with Anja Streicher, chief marketing officer at Women of Wearables, a global community offering events and education resources to support the femtech industry, to discuss trends in the women's wearables tech market, challenges and innovators pushing the boundaries.