…effective treatment or diagnosis as compared to the current standard of care. For example, if there is information supporting the device’s use in diverse settings such that a patient population…
…effective treatment or diagnosis as compared to the current standard of care. For example, if there is information supporting the device’s use in diverse settings such that a patient population…
…the component materials of the device with the body. The new guidance includes recommendations on the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations,…
…the component materials of the device with the body. The new guidance includes recommendations on the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations,…
…results. For example, data strategies that work well for traditional product development and commercialization are not always the right match for digital health. In addition, many companies lack regulatory wisdom…
…results. For example, data strategies that work well for traditional product development and commercialization are not always the right match for digital health. In addition, many companies lack regulatory wisdom…
…the patient experience and foster better communication between doctors and their patients. Through this technology, medical professionals can present complex information in an accessible and visually compelling manner. Enhanced Symptom…
…the patient experience and foster better communication between doctors and their patients. Through this technology, medical professionals can present complex information in an accessible and visually compelling manner. Enhanced Symptom…
On September 6, the FDA published three new draft guidances as part of its efforts to modernize the 510(k) Program with the goal of improving the safety of medical devices…
On September 6, the FDA published three new draft guidances as part of its efforts to modernize the 510(k) Program with the goal of improving the safety of medical devices…
…to propel the biotech industry into a new era of M&A activity. Could 2024 be the year that finally reshapes the M&A narrative? The Coming Patent Cliff In the coming…
…to propel the biotech industry into a new era of M&A activity. Could 2024 be the year that finally reshapes the M&A narrative? The Coming Patent Cliff In the coming…
