Hi @sabineThe reply function isn't working for me today. You've...

Hi @sabine

The reply function isn't working for me today. You've posted some good information. We at HC appreciate it.

Last year EBR announced a trading halt because some technical issues surrounding the transmitter caused the battery to deplete faster than expected in about 5% of devices. I am guessing the problem was reported to the FDA before EBR had time to inform the market. Hence the trading halt. Batteries can deplete in pacemakers, defibrillators, and CRT devices. When they do, the manufacture is obliged to issue an advisory to its customers, and to report the problem to the FDA. If you google 'battery depletion' and 'pacemakers', 'cardiac devices' and 'FDA' you will discover many advisories issued by Boston Scientific, Abbott Labs, Medtronic, and others. The causes of battery depletion are many and varied.

Just because a device is FDA approved doesn't mean manufacturers no longer have to pay attention to quality control. The FDA insists on giving oversight to ensure devices continue to meet safety standards. As they should. The manufacturing processes are usually to blame, which can manifest in material faults.

Power depletion issues are unfortunately not that uncommon in the cardiac device market. I think any extra testing can only strengthen EBR's final FDA submission. That's what the CEO said.

The rechargeable battery project is not part of the FDA submission. In future, if a battery is depleting faster than desired then the ease of recharging may mitigate some risks.

I'm comfortable with not knowing the detailed technical reasons that the final PMA module wasn't submitted in Q1 this year. It's EBR's prerogative. I will be totally satisfied when EBR announces the final module has been lodged. And hooray for that!