Device Area
Keep an eye on next year’s over-the-counter drug user fee negotiations for insights into the incoming Republican administration's approach to device regulation, attorneys said in a recent webinar. Other areas to watch include AI and diagnostics regulation, with potential bipartisan agreement on AI oversight
A Medtronic-funded study will use Tempus’ Next Cardiology platform to identify aortic and mitral heart valve disease patients who are being undertreated.
During an online seminar Tuesday, the FDA offered guidance on registration and listing requirements for lab-developed tests that will go into effect on 6 May 2026.
Incoming EU health commissioner gets to grips with need for MDR review and faces demands from council ministers for centralized elements in EU devices legislation.
After raising $68m series B funding in September, Neo Medical's announced on 2 December that its entire product portfolio has secured EU MDR approval. Co-CEO and founder Vincent Lefauconnier explained the rationale to Medtech Insight.
Exact Sciences lowered its full-year 2024 midpoint guidance by $90m. Commercial adjustments to the sales force are being made "to fix the basics," senior company executives told the Jefferies London Healthcare Conference.
Guardant Health expects to break even by 2028. A positive pricing outlook for the Guardant 360 lab test could bring this forward by maybe one year, CFO Mike Bell told the Jefferies London Healthcare Conference.
Medtech Insight spoke with Meghan Scanlon, president of Boston Scientific’s urology division, about integration plans for the recently acquired Axonics medtech. The purchase adds sacral neuromodulation to Boston Scientific’s portfolio, a global market that research reports valued at $1.6bn in 2023.
This week, the US device center announced a pilot program to speed communications about high-risk recalls; Cardinal paid $3.9B for Advanced Diabetes Supply Group and GIA Alliance; a companion diagnostic for Merck lung cancer drug Tepmetko got FDA clearance; and more.
Medtech Insight spoke with executives from Spanish medtech firm Time is Brain about their wearable device that monitors stroke victims in real time, potentially saving lives.
Oz is widely seen as a gifted health communicator and has device-industry cred, but brings little experience running a large government organization or with the policy and budget challenges confronting Medicare and Medicaid.
Abbott is celebrating the opening of its new manufacturing facility in Ireland for diabetes care.
Despite the growing risks cybersecurity poses to the US healthcare system, the Department of Health and Human Services continues to face challenges in meeting the threat, according to a report from the GAO. The new report also provides recommendations for the department to beef up its cyber defenses.
This week, Zimmer Biomet announced a new role of chief movement officer for Arnold Schwarzenegger, J&J MedTech receives IDE approval for Ottava, Dassault Systèmes with US FDA develop first guide for virtual twins, Mainz Biomed and Thermo Fisher team up to fight colorectal cancer.
Massachusetts-based Harbinger Health has partnered with Memorial Sloan Kettering Cancer Center in New York to accelerate the validation of its AI-driven blood test for early-stage cancer detection. The company also recently presented encouraging data at two conferences.
France’s medtech sector is strong, growing and innovative. Medtech Insight spoke to several French medtech leaders about the unique features and pitfalls their industry may face.
23andMe cut 40% of its workforce and will discontinue its therapeutic program as part of ongoing restructuring. This comes after a data breach, series of layoffs and the resignation of its board members.
The US FDA has increased the number of devices cleared through its breakthrough program, which the agency established in 2015 to expedite access to products aimed at treating life-threatening and debilitating diseases.