Beginning October 1, 2023, the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot will expand to include the Office of Neurological and Physical Medicine Devices (OHT5).
This week Huma Therapeutics received FDA Class II 510(k) clearance for its Software as a Medical Device (SaMD) platform, potentially speeding approval of a variety of AI and machine-learning (ML)-powered digital health devices. We spoke with Kaushik Gune, U.S. Head of Healthcare at Huma, about the current state of digital health technologies, the value of partnerships to enhance the use of real world data and how digital health is likely to advance in the coming years.
The $16.6 billion acquisition will bring Abiomed’s breakthough Impella heart pumps into the Johnson & Johnson MedTech portfolio.
Physicians are looking for better ways to treat patients with congestive heart failure. This includes the integration of remote monitoring and novel technologies.
Although the medtech industry is expected to enjoy steady growth, device companies are still challenged to attract the skilled labor that manufacturing requires.
The certification comes at a time when many companies have been saying that the May 2020 deadline is too soon.
This major health threat is driving demand for more diagnostic tests and devices to treat cardiac problems.
Despite pricing pressures, several sectors within the medical device industry can expect to enjoy growth and attract attention from investors.
The Children’s National Health System is accepting proposals for technologies that address unmet needs in children.
The company continues to drive global expansion by investing in high growth segments and expanding its innovation pipeline to new markets.