Orthogonal worked with Brian Binkowski, to gain a clearer picture of the state of SaMD approvals in the U.S. Following is what they learned about the rate of FDA approvals and clearances and which companies are having the most success getting their products cleared for the U.S. market.
As part of its reorganization of the CDRH, the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office that will include the Office of Supply Chain Resilience (OSCR), Digital Health Center of Excellence (DHCoE), Office of Technology and Data Services (OTDS), Office of Readiness and Response (ORR) and Office of Equity and Innovative Development (OEID).
The Digital Medicine Society (DiMe) is partnering with PHTI, ZS, and other leading organizations to develop and launch core components of integrated evidence plans for digital health products to support faster regulatory approval and commercialization.
Emerging technologies, integrated vendor ecosystems and enhanced regulatory compliance will redefine care delivery and shape the needs of healthcare stakeholders. Following are six healthcare technology trends that will shape care delivery and the MedTech market in 2024.
“We are incredibly fortunate to welcome Dr. Rizk to our advisory board. Her remarkable track record and profound knowledge in digital health will be invaluable as we continue to be at the forefront of redefining patient monitoring standards.”
The integration of artificial intelligence (AI) into breast cancer detection and treatment is already making a profound impact. AI-powered algorithms enhance early detection by analyzing vast amounts of data and identifying subtle abnormalities often invisible to the human eye. These technologies empower healthcare professionals to make informed decisions, improving the accuracy of diagnoses and tailoring treatment plans to the specific genetic makeup and health conditions of individual patients. This integration represents a paradigm shift in the cancer care continuum.
“The V-CHAMPS Challenge showed us that artificial intelligence (AI) models that performed well on the synthetic patient data in Phase 1 also performed well on the RWD during Phase 2, highlighting the potential value of using synthetic data in AI model development.”
In his new role, Kesavan will assume responsibility for leading CitiusTech’s global delivery organization. This will encompass enhancing practice capability, service delivery maturity, market innovation to drive profitable business growth by collaborating across practices, markets, delivery and functions.
“The new framework will strengthen the MHRA’s ability to keep patients safe, while at the same time contributing to an environment which encourages the launch of the most innovative healthcare products that make a real difference to the public’s health. The roadmap sets out how we will work with stakeholders, including patients, as the process moves forward.”
Even AI models trained on general medical literature will have difficulty making sense of the nuances specific to primary care, which is full of unique jargon, abbreviations and other idiosyncrasies. As always, the proverbial devil is in the details. Any AI solution worth its salt must be fluent in the specific idioms of the field and empower clinicians to deliver the best care that they can.
