New treatments for neurodegenerative disease and motion disability will be developed by a research collaboration between digital healthcare solutions provider MC10 and US-based rehabilitation research hospital, Shirley Ryan AbilityLab.
The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
Micky Tripathi, head of The Office of the National Coordinator for Health Information Technology (ONC), thinks his office’s recent rule on AI transparency will do a good job of empowering both providers and tech developers. “I think it’s going to spur more adoption of AI-based tools in healthcare delivery, and hopefully, it’s going to establish a sort of mechanism for driving higher quality AI-based tools,” he stated during an interview this month at the Reuters Digital Health conference in San Diego. In December, the ONC finalized a new rule that instated transparency requirements for the use of AI in healthcare settings. It requires healthcare AI developers to provide more data about their products to customers, which could aid providers in determining AI tools’ risks and effectiveness. Under the new rule, AI vendors must share information about how their software works and how it was developed. That means disclosing information about ...
As the burden of documentation and various other administrative duties has increased, physician burnout has reached historical levels. In response, EHR vendors are embedding generative AI tools to aid physicians by drafting their responses to patient messages. However, there is a lot that we don’t yet know about these tools’ accuracy and effectiveness. Researchers at Mass General Brigham recently conducted research to learn more about how these generative AI solutions are performing. They published a study last week in The Lancet Digital Health showing that these AI tools can be effective at reducing physicians’ workloads and improving patient education — but also that these tools have limitations that require human oversight. For the study, the researchers used OpenAI’s GPT-4 large language model to produce 100 different hypothetical questions from patients with cancer. The researchers had GPT-4 answer these questions, as well as six radiation oncologists who responded manually. Then, the ...
On the afternoon of March 25, Yin Li, Secretary of the Municipal Party Committee of Beijing, met with Novartis Global CEO Wansheim, Pfizer Chairman and CEO Eberle, and Danaher Global President and CEO Bjørnen. Yin Li introduced the economic and social development of Beijing and the health condition of its residents. He said that the Beijing Municipal Government attaches great importance to residents’ health, vigorously develops health care, gives full play to the advantages of rich scientific and technological talent resources, and continuously improves the level of medical services for the people in the city. Beijing’s pharmaceutical and health industry has a good foundation and a perfect system. In recent years, it has laid out its biopharmaceutical industry in key areas such as cellular genes, nucleic acid drugs, new antibodies, etc., and has formed international leading source innovative varieties in the fields of antibody drugs and immunotherapy drugs. Beijing’s science ...
In the study, the Lymphoma Artificial Reader System accurately detected 90% of lymphatic cancersResearchers from Chalmers University of Technology in Sweden have developed a new computer model using artificial intelligence (AI), which successfully identifies signs of lymphatic cancer. The model was developed in collaboration with researchers from Memorial Sloan Kettering Cancer Center, Chalmers University of Technology, Medical University in Vienna, Icahn School of Medicine at Mount Sinai and NYU Langone Health, with results published in The Lancet Digital Health. Lymphoma is a cancer of the lymphatic system, including the lymph nodes, spleen, thymus gland and bone marrow, and can affect other organs throughout the body. The two main subtypes of lymphoma are Hodgkin’s lymphoma and non-Hodgkin’s lymphoma, which is the sixth most common cancer in the UK, responsible for around 14,200 cases every year, according to Cancer Research UK. Using AI-assisted image analysis of lymphoma, researchers developed a deep learning ...
The National Institute for Health and Care Excellence (NICE) has recommended two artificial intelligence (AI)-powered software tools for use in the NHS for stroke diagnosis. The two softwares – e-Stroke and RapidAI – were selected after the health technology assessment agency found some evidence of faster and better access to treatment after using the software. Currently the leading cause of disability, responsible for more than 100,000 cases in the UK every year, a stroke is a life-threatening medical condition that occurs when the blood supply to parts of the brain is cut off. NICE advised that the software tools can be used within the NHS “while further evidence is generated to help better determine their cost-effectiveness”. The institute also noted that some form of AI was deployed in 99 out of 107 stroke units in England. e-Stroke, developed by Brainomix, was implemented in hundreds of hospitals in the UK, as ...
The Medicines and Healthcare products Regulatory Agency (MHRA) has set out a regulatory roadmap to enable safe access to medical technology, including artificial intelligence (AI) and diagnostics. The Roadmap Towards the Future Regulatory Framework for Medical Devices will support the development of new regulations that will prioritise patient safety and help ensure individuals continue to have access to the devices they need without delay, while enhancing the UK’s position as “a world-leading environment for medical technology innovators,” the MHRA said. The roadmap is also set to offer “significant new opportunities for patients and healthcare” by enhancing the UK’s ability to benefit from advancing medical technology such as implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease. Dr Laura Squire, the MHRA’s MedTech regulatory reform lead and chief officer of healthcare, quality and access, said: “Today’s exciting medical technology advances offer important new opportunities for ...
GLP-1s — which lower blood sugar to help people lose weight — are taking the healthcare industry by storm and have several implications for digital health companies. This includes headwinds for established nutrition programs and the potential for the launch of new virtual weight loss startups, according to a PitchBook report published Friday. The PitchBook authors believe that because of the prevalence of obesity in the U.S., the impact of GLP-1s “will extend far beyond the drugmakers themselves.” So far, four GLP-1 agonists have FDA approval: Ozempic, Rybelsus, Wegovy and Mounjaro. Wegovy, however, is the only one indicated for weight loss, while the others are indicated for Type 2 diabetes. PitchBook listed the potential effect of weight loss drugs on several specific VC-backed digital health companies. For example, Ro and Noom may see new customers through their weight loss telehealth offerings. Form Health could see a rising adoption of their ...
Dive Brief Enovis has struck an agreement to buy orthopedics company LimaCorporate for 800 million Euros ($847 million). The acquisition of the Italy-based company will scale Enovis’ global reconstruction unit, creating a $1 billion business that is forecast to grow in the high single digits and generate $40 million in cost synergies over the next three years. Vik Chopra, an analyst at Wells Fargo, said the acquisition was “much larger than what we were expecting,” in a conference call with Enovis management. Shares in Enovis rose 5% to $54.16 after the Delaware-based company disclosed the deal. Dive Insight Enovis, formerly called Colfax, has grown its operations through a series of acquisitions since the start of the decade, globalizing its reconstruction business with the $285 million takeover of Mathys in 2021 and adding other assets to establish and build its foot and ankle business. “At the time [of the Mathys deal], ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.