As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.
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.
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.
Octave Bioscience’s CEO Doug Biehn sat down with Medtech Insight at HLTH to talk about the company’s plans for expanding their multivariate biomarker blood test for MS analysis and development of a diagnostic for Parkinson’s disease.
The US FDA’s advisory panel on general and plastic surgery devices voted in favor of agency approval for a novel medical device for treating early stage, low-risk breast cancer as a potential alternative to lumpectomy. The agency is expected to make its decision on the device early next year.
In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia about his vision for AI in health care and other highlights from HLTH. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results.
The company has taken the ambitious approach of establishing a manufacturing base capable of producing millions of devices before any attempt at a regulatory submission.
Patients treated with Abbott’s Esprit BTK system had better results and fewer repeat procedures after two years than a control group, the company announced this week. Abbott vascular leader Jennifer Jones-McMeans spoke with Medtech Insight about what the results could mean for patient care.
This week, HistoSonics announced it will bring its ultrasound system for destroying liver tumors into VA hospitals, Edwards Lifesciences reports encouraging TRISCEND II trial results at TCT, study finds blood test for CRC screening are less cost-effective than alternatives, and more.
Medtech Insight talked with GE HealthCare’s chief AI officer Parminder “Parry” Bhatia at HLTH about the firm’s new CareIntellect for Oncology offering to help clinicians make efficient use of multimodal patient data, his vision for projects within AI Innovation Lab, and the future of AI in health care.
House Republicans say the FDA has not done enough to support its laboratory safety office, despite past recommendations.
Oxford Medical Products (OMP) announced positive results from its first randomized controlled trial of weight loss device Sirona, an inert dual-polymer hydrogel pill that expands in the stomach to mechanically suppress appetite. CEO Camilla Easter views the device as complementary and potentially synergistic with GLP-1 receptor agonists “at a fraction of the cost.”
Medtech Insight spoke with Vicky Demas, CEO of Identifeye, about plans for bringing the company’s AI-powered retinal screening system for early detection of diabetic retinopathy to primary care facilities. More than 50% of the roughly 38 million Americans who have diabetes skip retinal screenings at present, increasing risk of developing the leading cause of blindness in adults.
The medical device industry supports the FDA's draft guidance document on Diversity Action Plans but seeks flexibility and clarity, especially for international and IVD trials, and recommends using real-world data for postmarket studies.
During the Medtech Conference in Toronto, three of the industry’s leading CEOs shared their insights into the rapidly changing landscape of health care and how the latest advancements have the potential to make life better for patients everywhere.
Start-ups pitched a diverse deck of innovative technologies to three judges and an audience of potential investors, strategics and physicians at the Octane Medical Innovation Forum in Irvine, CA. Highlights include neuromodulation company Sinaptica Therapeutics, which won the competition for both “People’s Choice” and “Judge’s Choice.”
Slow adoption of alternatives to animal testing in the current decentralized regulatory framework shows the need for a ‘one-stop shop’ at FDA that can provide advice, precedents and qualification programs.