PC-based ECG systems (resting, stress and long-term ECG) and ABPM including cardiology software
Pulse Biomedical, Inc.
King of Prussia, PA (USA) · Meßstetten (DE)New on Amplifa
About Pulse Biomedical
Pulse Biomedical, Inc. (PBI), headquartered in King of Prussia, Pennsylvania (USA), is a supplier of computer-based cardiology diagnostic systems under the QRS-Card™ brand. The portfolio includes resting ECG, stress ECG, long-term ECG (Holter) and ABPM (24-hour blood pressure measurement) as well as the QRS-Card™ Cardiology Suite, which turns a laptop, notebook or tablet into a complete cardiology diagnostic workstation. Originally, PBI was an FDA-registered manufacturer that developed its own hardware and software for diagnostic-quality twelve-lead ECG devices; today the company acts as a reseller of these systems. Ownership of the hardware design and source code, including automatic ECG measurement and interpretation algorithms as well as the 24-hour Holter algorithm, remains with the company. Distribution is handled through independent distributors worldwide as well as in the OEM business, among others for Oxford Instruments, Ergoline, Guident and Cardinal Health. A branch office in Meßstetten (Germany) serves the European market.
- Site
- King of Prussia, PA, USA
- Processes
- PC-based cardiology diagnostic software (QRS-Card Cardiology Suite), Resting ECG, Stress ECG, Holter ECG, ABPM, OEM manufacturing, Distribution via independent distributors worldwide, Technical support
- Materials
- QRS-Card™ ECG Hardware, QRS-Card™ Cardiology Suite
- Certificates
- FDA approval (USA), CE marking, Approval Canada/Japan/China
- Industries
- Medical technology, Cardiology
- 01
Development/ownership of hardware design and software source code
- 02
Manufacturing (historical, FDA-registered)
- 03
Distribution via independent distributors worldwide
- 04
OEM manufacturing for third parties
- 05
Technical support
Products & Software
QRS-Card™ ECG Hardware
External hardware module (approximately hand-sized) with connection to PC via serial interface, USB or Bluetooth.
QRS-Card™ Cardiology Suite
PC-based software for managing all resting, stress and Holter ECG/ABPM patient data and reports.
Locations
King of Prussia, PA, USA
USHeadquarters / Sales
Meßstetten, Germany
DEGerman Branch Office
Products
Inside the production
Industries
Additional services
Reference customers
Quality & Approvals
In addition to the US FDA approval, approvals exist in Canada, Japan and China as well as CE marking for the European market.
| Evidence | King of Prussia, PA, USA |
|---|---|
| FDA approval (USA) | |
| CE marking | |
| Approval Canada/Japan/China |
History
- 1991
FDA approval for Resting QRS-Card ECG (November)
- 1998
FDA approval for Stress ECG (July)
- 2003
FDA approval for Holter ECG (January)
- 2010
FDA approval for Bluetooth Wireless ECG (July)