PMD Solutions Announces Successful FDA Pre Submission Meeting and Progresses with Plans for FDA 510K Submission in 2017 ‘RespiraSense’
PMD Solutions, an Irish Medical Technology firm, announces a successful Pre Submission meeting with the FDA for ‘RespiraSense’, the world’s first respiratory rate wearable specifically designed for trend monitoring of acute patients. RespiraSense is a novel technology that provides medical staff an alert to abnormal breathing, one of the earliest signs of possible patient deterioration from conditions such as respiratory compromise, worsening pneumonia, increasing severity of sepsis, and oncoming heart attacks, through trend monitoring respiratory rate. Respiratory rate is shown to be the earliest and most sensitive sign of patient deterioration. The benefit of having RespiraSense is that it can support the timely identification of deterioration, leading to improved interventions, resulting in better patient outcomes – lower length of stay, fewer preventable ICU admittance, and lower cost of care. RespiraSense has been successfully trialled in the perioperative setting and it is a timely technology that will address the global clinical need for robust monitoring of patients on the general and post-operative care floors.
Myles Murray CEO of PMD stated “Resulting from the successful pre-submission milestone, PMD plans to proceed with FDA 510K submission in 2017. PMD Solutions is entirely focused on improving patient outcomes by making every breath count. Respiratory rate’s value has been significantly published for the last 10 years, and yet manual counting breaths remains to be the global industry standard. Spontaneous breathing is challenging to measure accurately, however, this challenge has become PMD’s advantage as a result of its novel wearable respiratory sensor technology.”
“RespiraSense has centres of excellence across Europe with world-leading opinion leaders in the field of vital signs and patient deterioration. With the increasing pressures put onto healthcare institutions, prevention is the word when it comes to addressing both financial savings without compromising patient safety.”
“PMD’s novel platform technology will provide clinicians important and timely trending information to help prevent in-hospital adverse events. This technology supports global (Early Warning Score) initiatives while also providing a boost towards the implementation of digital (and paperless) healthcare”.
“We look forward with confidence to our ongoing clinical investigations within in emergency, perioperative and acute medicine settings. All demonstrating that a positive impact to both outcomes and financial savings is a reality.”
– Myles Murray-