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A New Voler Systems Case Study

Heart Pump Console Software Passes FDA Review with Zero Conditions, Facilitating Faster Path to Clinical Trials

This large medical device company sells cardiac equipment. It acquired a smaller company with a proof-of-concept heart pump that serves as a lifesaving solution for people undergoing heart surgery.

Problem/Goal

• The organization lacked software expertise to develop software for a Class III medical device.
  
  The pump's design augments the heart's pumping function during surgery and reduces the risk of death for patients with a high mortality rate. The pump folds into a catheter, is inserted into the femoral vein in the thigh, guided to the heart, and then is unfolded to begin pumping. The heart pump includes a console with a display, sensors, and controls. 
  
  
• Needed to modify the pump's electronics and provide the user with error alerts to prevent device failure.
  
  The console measures and controls the speed of the pump and, therefore, the blood volume. It also measures pressure and detects any blood leakage into the pump drive system. The software had to control the pump, measure sensors, and provide an intuitive user interface to alert the user of any potential problems.

Please Join Voler at Any of These Events in June, if You Happen to be in the San Francisco / Santa Clara Area

Voler National Networking Series 2023
Next City: Santa Clara CA

If you are based in Silicon Valley, and if you want to join Voler Systems for a networking evening at the BareBottle Taproom in Santa Clara on Thursday, June 15th, please drop Miguel a note at miguel.adao@volersystems.com. We will have a private area at the venue from 5:30 pm to 8:00 pm, but we do have a limit of 40 people for our space. It should be a fun evening. We will have a guided beer-tasting tour and everything! Will you join us? Please let us know asap. 

Coming to the Wilson Sonsini Medical Device Conference? Let's Meet for Coffee.

Voler's President Walt Maclay and a few members of his team will be attending Wilson Sonsini's Medical Device Conference on June 15-16, in San Francisco.

 Will you also be attending? Please let us know. Let's meet for a coffee there!

Let's Connect at #SensorsConverge

Learn more about IoT data transmission, the various communication standards, and the changes coming in the future at my talk at Sensors Converge on June 22.

Voler's Walt Maclay will dive into 5G’s impact on IoT and wearable devices on Thursday, June 22, at 10:10 am PDT in Grand Ballroom G.

Use code MACLAY for $100 off your All-Access Pass or a FREE Expo Hall Pass. Take advantage of the discount by registering today!

https://www.sensorsconverge.com/sensorsconvergecom/register

Abstract of Walt Maclay's Talk at the Event

5G is being heavily promoted to make IoT better, but 5G is focused on high data rates and low latency, which is not needed for most IoT applications. The frequency bands used by 5G are:

• Low-band, Below 1 GHz
• Mid-band, 1-6 GHz
• High-band, 6-86 GHz

There are services in 4G or LTE (CAT-M and NB-IoT) that have now been adopted as part of 5G. They offer low band width wide area communication at low power. At 100 bps, they can transmit directly to a cell tower at a power level that is about 20 times lower than a standard 5G modem. They are compatible with 5G and are promised to co-exist with 5G for many years. For IoT applications that have low data rates, CAT-M and NB-IoT are the preferred choice.

Watch the Webinar Recording of "Inside the Latest FDA Guidance on mHealth Security for Your Mobile Pipelines"

Voler has helped many premier clients turn product ideas into reality. Whether you’re looking for Wearable Technology, Circuit Design, Electronic Design, Wireless, Sensors, Software and Firmware, Motion Control, or FPGA Development, Voler can help you identify risks while keeping the projects on time, on budget, and easy to manufacture.