Market Access
Researchers from the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Center are testing Digostics’ GTT@home test in children to assess if it offers a better alternative to the clinical gold-standard oral glucose tolerance test.
Boston Scientific has integrated cardiac mapping and pulsed field ablation into a single catheter with the newly EU-approved Farawave Nav Ablation Catheter. Faraview Software also receives CE marking, allowing for visualization of catheter placement when delivering therapy.
France-based Germitec aims to double its yearly revenue by expanding its UV-C disinfection technology for endocavitary ultrasound probes into the US market.
PathAI, a Boston-based AI-pathology startup backed by $355m, partners with Brazil’s largest integrated healthcare network to support diagnosis and treatment of cancer patients using its AISight image management system.
Precision medicine startup LinusBio launches its breakthrough diagnostic aid across 44 US states. The laboratory test aims to support earlier diagnosis of autism spectrum disorder and can be ordered by health care providers.
The UK's established emergency care prehospital system potentially opens up a faster route to market for Front Line Medical Technologies's aortic occlusion device, COBRA-OS. Asha Parekh, Front Line CEO, talks to Medtech Insight about the company's different strategic approach to UK market access in comparison to North America.
Healthcare experts believe that India’s ban on imports of refurbished medical devices has left a vacuum and if an implementable policy is not introduced soon, it could prove disastrous for healthcare providers and patients.
Quibim announces $50m in an oversubscribed series A funding round. Quibim CEO Ángel Alberich-Bayarri discusses his plans for the new financing and the company’s competitive edge in training AI with multimodal data.
Boston Scientific's Farapulse Pulsed Field Ablation System achieved safety and effectiveness endpoints in the ADVANTAGE AF clinical trial for the treatment of persistent atrial fibrillation, supporting “the paradigm shift to pulse-field ablation,” said Vivek Reddy, director of electrophysiology at Mount Sinai Fuster Heart Hospital.
Guardant Health seeks to bring genomic cancer disease data into a clinical context in a new collaboration with ConcertAI aimed at designing cancer therapeutics and clinical trials, Amar Das, VP of real world evidence at Guardant Health, told Medtech Insight.
"Medtronic's device is the only DBS with adaptive capability," Amaza Reitmeier, vice president and general manager of Brain Modulation at Medtronic, told Medtech Insight. Two new BrainSense features work together to provide personalized brain stimulation for patients with Parkinson's disease.
Scotland has a strong foundation of medtech research, but to reach the ‘tipping point’ where it has gained critical startup mass, it must overcome funding challenges and foster corporate startup partnerships.
Medtechs will be indirectly affected by a new law in Switzerland that unifies the amount of funding allocated to inpatient and ambulatory care.
While medtechs still find the investment environment difficult, good companies will continue to get funded. So says Taylor Wessing partner Ross McNaughton, adding that UK life sciences innovators should in the longer-term benefit from more funds going into VC and PE under The Mansion House Compact.
MHRA AI Airlock participant Lenus Health has secured three UK provider agreements for use of its COPD predictive AI risk stratification tool for use in the NHS.
New tax on firms will leave less room for business growth, UK medtechs fear.
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.
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.
Device supply interruptions and withdrawals, now common in the EU, could threaten patient safety. Newly issued manufacturer guidance from the European Commission is intended to improve transparency and minimize disruption.
The co-founder of Pure Global discusses the regulatory consultancy's use of AI to support clients’ marketing submissions and other needs, as well as the AI-enabled medtech landscape and opportunities in China and Southeast Asia for accessing patient data for AI development purposes.