FDA News

Injectable cardiac monitor receives FDA clearance

Biotronik announced that an injectable cardiac monitor to identify unexplained syncope or suspected arrhythmia has received FDA clearance.

The injectable cardiac monitor (Biomonitor III) is 60% smaller than previous versions and is preloaded in an injection tool to simplify the insertion process, according to a press release from the company.

This tool can be used in office-based procedures and has been shown to reduce procedural costs and case times. The accuracy to detect and diagnose arrhythmias with this monitor has been improved with increased signal quality and a patient application for patient-provider engagement, in addition to system diagnostics and the ability to note symptoms, according to the press release.

“When physicians are not burdened by poor signal quality, clinically irrelevant data, inaccurate, or worse, missed detections, more time can be devoted to ensuring a timely and accurate diagnosis,” Raul Weiss, MD, FACC, professor of clinical medicine and director of the electrophysiology fellowship program at Ohio State University Medical Center, said in the press release.

The monitor has a feature (Intelligent Memory Management) to improve workflow performance and to deliver the most relevant detections, according to the press release. It also has a home monitoring system and is MR conditional for both 1.5 T and 3 T applications.

This device maintains exceptional functionality in detecting arrhythmia and its reduced size and novel delivery tool simplifies the injection procedure,” Ryan Walters, president of Biotronik, said in the press release. “Physicians and patients can count on Biomonitor III to deliver timely and accurate data to identify potentially life-threatening cardiac arrhythmias faster and more confidently than ever before.”

Disclosures: Walters is an employee of Biotronik. Weiss reports he received grants/research support from Biosense Webster, Biotronik, Boston Scientific, Medtronic and St. Jude; consults for Biosense Webster, Biotronik, Boston Scientific and Merit Medical, and is on the advisory board for Biosense Webster and Boston Scientific.

Biotronik announced that an injectable cardiac monitor to identify unexplained syncope or suspected arrhythmia has received FDA clearance.

The injectable cardiac monitor (Biomonitor III) is 60% smaller than previous versions and is preloaded in an injection tool to simplify the insertion process, according to a press release from the company.

This tool can be used in office-based procedures and has been shown to reduce procedural costs and case times. The accuracy to detect and diagnose arrhythmias with this monitor has been improved with increased signal quality and a patient application for patient-provider engagement, in addition to system diagnostics and the ability to note symptoms, according to the press release.

“When physicians are not burdened by poor signal quality, clinically irrelevant data, inaccurate, or worse, missed detections, more time can be devoted to ensuring a timely and accurate diagnosis,” Raul Weiss, MD, FACC, professor of clinical medicine and director of the electrophysiology fellowship program at Ohio State University Medical Center, said in the press release.

The monitor has a feature (Intelligent Memory Management) to improve workflow performance and to deliver the most relevant detections, according to the press release. It also has a home monitoring system and is MR conditional for both 1.5 T and 3 T applications.

This device maintains exceptional functionality in detecting arrhythmia and its reduced size and novel delivery tool simplifies the injection procedure,” Ryan Walters, president of Biotronik, said in the press release. “Physicians and patients can count on Biomonitor III to deliver timely and accurate data to identify potentially life-threatening cardiac arrhythmias faster and more confidently than ever before.”

Disclosures: Walters is an employee of Biotronik. Weiss reports he received grants/research support from Biosense Webster, Biotronik, Boston Scientific, Medtronic and St. Jude; consults for Biosense Webster, Biotronik, Boston Scientific and Merit Medical, and is on the advisory board for Biosense Webster and Boston Scientific.