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Bardy Diagnostics

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uuid0002a8y

Namestring
Bardy Diagnostics
Legal namestring
Bardy Diagnostics, Inc.
Websiteurl
bardydx.com
Company typeenum
Private
Founded yearint
2013
Descriptiontext

Bardy Diagnostics is a US-based developer of ambulatory cardiac monitoring technology, founded in 2013 by electrophysiologist Gust H. Bardy, M.D. The company's flagship product is the Carnation Ambulatory Monitor (CAM) Patch, a single-use, wire-free ECG patch designed for extended wear up to 14 days. The CAM Patch is placed along the sternum to optimize P-wave signal capture, addressing the limited atrial signal clarity that constrains conventional Holter and competing patch monitors. The company complements the device with the BDxCONNECT cloud-based patient management portal (HIPAA-compliant, ISO/IEC 27001 certified, with EHR integration API) and the proprietary CAM Report, a multi-field diagnostic report format that combines near-field, medium-field, and far-field R-R interval views, delivered within an average of under 48 hours after data upload.

The company monetizes through hardware sales of the CAM Patch and professional ECG analysis services performed by CRAT- and CCT-certified technicians (operated via Baxter's Independent Diagnostic Testing Facility), reimbursed under CPT codes for continuous cardiac monitoring of 48 hours to 15 days. An in-house convolutional neural network analyzes ECG recordings and R-R interval data to produce AF yes/no output every half-second, with published performance of 96.82% sensitivity and 99.86% specificity. Bardy sells primarily through a direct enterprise sales force targeting electrophysiologists, cardiologists, hospitals, and health systems, supported by clinical evidence from peer-reviewed head-to-head studies against Holter, Zio XT, and MCT.

Bardy Diagnostics operates from its Bellevue, Washington headquarters with operational centers in Houston TX, New Providence NJ, and Milpitas CA. In 2025, the company was acquired by Baxter International Inc. and now operates as a wholly-owned subsidiary, with all trademarks (BardyDx, CAM, BDx Design) owned by Baxter. The firm is private and does not publicly disclose revenue.

Short descriptiontext

Bardy Diagnostics develops the P-wave centric Carnation Ambulatory Monitor (CAM) Patch, a wire-free ECG patch for up to 14-day cardiac monitoring, along with the BDxCONNECT portal and AI-powered AF detection. The company serves electrophysiologists, cardiologists, and hospitals in the United States and operates as a subsidiary of Baxter International Inc.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersSeattle, United States
HQ citystring
Seattle
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Offices4 records

Each record includes

City, Country, Type, Description, Source

Keyword5 values
ambulatory cardiac monitoring, ECG patch monitor, P-wave centric ECG, atrial fibrillation detection, remote cardiac monitoring
Industry1 code
1Cardiac Monitoring (ECG/Holter/Event/Patch, Loop Recorders)
CodeHLAHACABPrimaryYes
NAICS code2 codes
  • Electromedical and Electrotherapeutic Apparatus Manufacturing334510
  • Medical Laboratories621511
SIC code2 codes
  • Electromedical & Electrotherapeutic Apparatus3845
  • Services-Medical Laboratories8071
Product category
Ambulatory Cardiac Monitoring Devices
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model2 records
1Ambulatory Cardiac Monitoring Services
TypeHardware Sales
Description

The company generates revenue through the sale of CAM Patch devices and associated monitoring services. Services include ECG data collection, analysis by certified ECG technicians (CRAT- and CCT-certified), and CAM Report generation. Reimbursement is based on CPT codes for continuous cardiac monitoring ranging from 48 hours to 15 days. The company provides billing support through its Customer Experience Team and offers multiple payment options for patients including phone, online, and mail payment methods.

bardydx.com
2ECG Analysis and Reporting Services
TypeProfessional Services
Description

Revenue generated from professional ECG analysis services provided through Baxter's IDTF (Independent Diagnostic Testing Facility) within the United States. Reports are prepared by certified technicians and provided within 2 business days. Practices can also choose to analyze data using their own in-house ECG technicians.

bardydx.com
Marketing channels8 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels3 records

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components5 values
Personnel, Operations, Technology or R&D, Marketing or Sales, Supply Chain
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Brand1 of 3 records shown
1CAM (Carnation Ambulatory Monitor)
Description

P-wave centric ECG patch monitor for ambulatory cardiac monitoring, designed to optimize P-wave signal capture and deliver high diagnostic accuracy for detecting arrhythmias.

bardydx.com
+2 more records
Core offering1 text field

Bardy Diagnostics develops, manufactures, and sells the Carnation Ambulatory Monitor (CAM) Patch, a single-use P-wave centric ECG patch monitor for up to 14 days of continuous ambulatory recording, paired with the BDxCONNECT cloud-based patient management portal and the proprietary multi-field CAM Report. Revenue is generated from CAM Patch device sales and associated ECG analysis and reporting services performed by certified technicians, with reimbursement under CPT codes for continuous cardiac monitoring ranging from 48 hours to 15 days.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 5 values shown
  • 96% of patients prefer CAM Patch over 3-lead standard Holter monitor
+4 more records
Product overview1 text field

Bardy Diagnostics offers a unified ambulatory cardiac monitoring solution centered on three integrated components: the Carnation Ambulatory Monitor (CAM) Patch (a P-wave centric ECG patch designed for up to 14-day extended wear), the BDxCONNECT cloud-based patient management and EHR integration portal, and the CAM Report system (delivering multi-view ECG analysis within 2 business days). These products work together as an end-to-end solution enabling patient monitoring, secure data upload, expert ECG analysis by certified technicians, and rapid clinical reporting.

Product and service4 records
1Carnation Ambulatory Monitor (CAM) Patch
CategoryAmbulatory Cardiac Monitoring Device
Description

Lightweight, wire-free, single-use P-wave centric ECG patch monitor designed for up to 14 days of continuous ambulatory recording along the sternum, enabling patients to mark symptoms via a button and capturing every heartbeat with optimized atrial signal clarity for arrhythmia diagnosis.

2BDxCONNECT Portal
CategoryCardiac Monitoring Data Platform
Description

HIPAA-compliant, ISO/IEC 27001-certified web-based patient management portal that supports patient registration, secure cloud transmission of patch monitor data, EHR integration via API, automatic notifications and alerts, and physician-editable online reporting.

3CAM Report
CategoryDiagnostic ECG Reporting
Description

Proprietary report format providing multiple diagnostic field views including Near-Field (8-second traditional view with R-R measurements), Medium-Field (56-second snapshot with 24 seconds pre/post episode), and Far-Field (40-minute R-R interval plot with 20 minutes pre/post) for enhanced arrhythmia diagnosis.

4ECG Analysis and Reporting Services
CategoryCardiac Diagnostic Services
Description

Professional ECG analysis services performed by CRAT- and CCT-certified ECG technicians, with CAM Reports prepared within 2 business days and practices retaining the option to perform analysis using their own in-house ECG technicians.

Scale indicator7 records

Each record includes

Type, Value, Description, Source

Partnership1 partner
Strategic tierCoreTypeOthers
Description

Bardy Diagnostics is now part of Baxter. The company operates as Bardy Diagnostics, Inc., a subsidiary of Baxter International Inc. All trademarks (BardyDx, Bardy Diagnostics, BDx Design, CAM) are owned by Baxter International Inc. or its subsidiaries. The redirect page confirms 'Bardy Diagnostics is now part of Baxter.'

Recent move7 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight5 records

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

Public competitor (Zio patch) and the most direct peer — Bardy explicitly benchmarks clinical performance against Zio XT in published head-to-head studies, with overlapping electrophysiologist and cardiologist customer base.

TypeEmerging player
Description

Offers a 7-lead wearable ECG patch with AI-powered arrhythmia detection; competes in ambulatory cardiac monitoring with overlapping remote-monitoring use cases targeting similar cardiology customers.

TypeRegional player
Description

Australia-based developer of diagnostic ECG, Holter, and sleep monitoring systems; comparable in ambulatory cardiac monitoring hardware/services but primarily serves Asia-Pacific and select international markets rather than US focus of Bardy.

TypeEmerging player
Description

Developer of a credit-card-sized 3D ECG device for remote cardiac monitoring with AI-driven synthesis; competes in ambulatory arrhythmia detection with overlapping cardiology customer base.

TypeBroad incumbent
Description

Provides ECG management systems, Holter analysis, and cardiac diagnostic infrastructure widely deployed in hospitals; competes indirectly via incumbent ECG analysis platforms that integrate with hospital cardiology workflows.

TypeBroad incumbent
Description

Acquired Preventice Solutions (BodyGuardian) to enter remote cardiac monitoring; broader medtech incumbent now offering ambulatory ECG patch monitoring services directly competing with CAM Patch for cardiology accounts.

TypeBroad incumbent
Description

Acquired BioTelemetry to offer a broad portfolio including MCT (mobile cardiac telemetry) and ECG monitoring services; competes in ambulatory cardiac monitoring space though as part of a much larger diagnostic and patient monitoring portfolio.

TypeDirect peer
Description

Maker of KardiaMobile ECG devices and AI-based AF detection algorithms; addresses the same electrophysiologist and cardiologist customer base for arrhythmia detection, though primarily via handheld/smartphone rather than patch form factor.

TypeEmerging player
Description

Developer of the Cardea SOLO wearable ECG sensor and AI-based arrhythmia analysis; smaller, earlier-stage competitor in the same ambulatory cardiac patch category with overlapping electrophysiologist customers.

TypeBroad incumbent
Description

Hillrom (now part of Baxter, parent of Bardy Diagnostics) provides Welch Allyn vital signs and bedside patient monitoring; potential channel partner and broader incumbent in hospital-based cardiac and patient monitoring.

Market position
Strengths5 records

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Headline, Details, Source

Weaknesses5 records

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Competitive moat4 records

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Type, Details

Key risks6 records

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Key highlights7 records

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Customer concentration

Classification, Details

Named customers2 records

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Name, Industry, Type, Use case, Source, UUID

Segment3 records

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Ideal customer profile2 records

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Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

AI capability2 records

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Type, Description, Source

AI maturity
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Has app

Feature5 records

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Core technology
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Profiles5 records

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No data
Compliance2 records

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Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds4 records

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Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors11 records

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Bardy Diagnostics

Ambulatory Cardiac Monitoring Devicesbardydx.com

Bardy Diagnostics develops the P-wave centric Carnation Ambulatory Monitor (CAM) Patch, a wire-free ECG patch for up to 14-day cardiac monitoring, along with the BDxCONNECT portal and AI-powered AF detection. The company serves electrophysiologists, cardiologists, and hospitals in the United States and operates as a subsidiary of Baxter International Inc.

What Bardy Diagnostics does

Bardy Diagnostics is a US-based developer of ambulatory cardiac monitoring technology, founded in 2013 by electrophysiologist Gust H. Bardy, M.D. The company's flagship product is the Carnation Ambulatory Monitor (CAM) Patch, a single-use, wire-free ECG patch designed for extended wear up to 14 days. The CAM Patch is placed along the sternum to optimize P-wave signal capture, addressing the limited atrial signal clarity that constrains conventional Holter and competing patch monitors. The company complements the device with the BDxCONNECT cloud-based patient management portal (HIPAA-compliant, ISO/IEC 27001 certified, with EHR integration API) and the proprietary CAM Report, a multi-field diagnostic report format that combines near-field, medium-field, and far-field R-R interval views, delivered within an average of under 48 hours after data upload.

The company monetizes through hardware sales of the CAM Patch and professional ECG analysis services performed by CRAT- and CCT-certified technicians (operated via Baxter's Independent Diagnostic Testing Facility), reimbursed under CPT codes for continuous cardiac monitoring of 48 hours to 15 days. An in-house convolutional neural network analyzes ECG recordings and R-R interval data to produce AF yes/no output every half-second, with published performance of 96.82% sensitivity and 99.86% specificity. Bardy sells primarily through a direct enterprise sales force targeting electrophysiologists, cardiologists, hospitals, and health systems, supported by clinical evidence from peer-reviewed head-to-head studies against Holter, Zio XT, and MCT.

Bardy Diagnostics operates from its Bellevue, Washington headquarters with operational centers in Houston TX, New Providence NJ, and Milpitas CA. In 2025, the company was acquired by Baxter International Inc. and now operates as a wholly-owned subsidiary, with all trademarks (BardyDx, CAM, BDx Design) owned by Baxter. The firm is private and does not publicly disclose revenue.

Bardy Diagnostics firmographics

Firmographics
Name
Bardy Diagnostics
Legal name
Bardy Diagnostics, Inc.
Website
https://bardydx.com
Company type
Private
Founded year
2013
Operating status
Operating
Headcount range
11–50 employees
Short description
Bardy Diagnostics develops the P-wave centric Carnation Ambulatory Monitor (CAM) Patch, a wire-free ECG patch for up to 14-day cardiac monitoring, along with the BDxCONNECT portal and AI-powered AF detection. The company serves electrophysiologists, cardiologists, and hospitals in the United States and operates as a subsidiary of Baxter International Inc.
Ownership category
akta.pro rank

Bardy Diagnostics industry classification

Industry
Product category
Ambulatory Cardiac Monitoring Devices
NAICS
Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Medical Laboratories (621511)
SIC
Electromedical & Electrotherapeutic Apparatus (3845), Services-Medical Laboratories (8071)
akta.pro primary industry
Cardiac Monitoring (ECG/Holter/Event/Patch, Loop Recorders) (HLAHACAB)

Keywords

  • Ambulatory cardiac monitoring
  • ECG patch monitor
  • P-wave centric ECG
  • Atrial fibrillation detection
  • Remote cardiac monitoring

Where Bardy Diagnostics is headquartered

Location

Headquarters

HQ city
Seattle
HQ country
United States
HQ region
North America

Offices4 records

Markets served

Bardy Diagnostics business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Personnel, Operations, Technology or R&D, Marketing or Sales, Supply Chain

Revenue model

  1. Ambulatory Cardiac Monitoring Services: The company generates revenue through the sale of CAM Patch devices and associated monitoring services. Services include ECG data collection, analysis by certified ECG technicians (CRAT- and CCT-certified), and CAM Report generation. Reimbursement is based on CPT codes for continuous cardiac monitoring ranging from 48 hours to 15 days. The company provides billing support through its Customer Experience Team and offers multiple payment options for patients including phone, online, and mail payment methods.
  2. ECG Analysis and Reporting Services: Revenue generated from professional ECG analysis services provided through Baxter's IDTF (Independent Diagnostic Testing Facility) within the United States. Reports are prepared by certified technicians and provided within 2 business days. Practices can also choose to analyze data using their own in-house ECG technicians.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels8 records

Bardy Diagnostics product offering

Product offering

Core offering

Bardy Diagnostics develops, manufactures, and sells the Carnation Ambulatory Monitor (CAM) Patch, a single-use P-wave centric ECG patch monitor for up to 14 days of continuous ambulatory recording, paired with the BDxCONNECT cloud-based patient management portal and the proprietary multi-field CAM Report. Revenue is generated from CAM Patch device sales and associated ECG analysis and reporting services performed by certified technicians, with reimbursement under CPT codes for continuous cardiac monitoring ranging from 48 hours to 15 days.

Product overview

Bardy Diagnostics offers a unified ambulatory cardiac monitoring solution centered on three integrated components: the Carnation Ambulatory Monitor (CAM) Patch (a P-wave centric ECG patch designed for up to 14-day extended wear), the BDxCONNECT cloud-based patient management and EHR integration portal, and the CAM Report system (delivering multi-view ECG analysis within 2 business days). These products work together as an end-to-end solution enabling patient monitoring, secure data upload, expert ECG analysis by certified technicians, and rapid clinical reporting.

Differentiator

Problem solved

Functional benefit

Brands

  • CAM (Carnation Ambulatory Monitor): P-wave centric ECG patch monitor for ambulatory cardiac monitoring, designed to optimize P-wave signal capture and deliver high diagnostic accuracy for detecting arrhythmias.
  • BDxCONNECT
  • CAM Report

Products and services

  • Carnation Ambulatory Monitor (CAM) Patch Lightweight, wire-free, single-use P-wave centric ECG patch monitor designed for up to 14 days of continuous ambulatory recording along the sternum, enabling patients to mark symptoms via a button and capturing every heartbeat with optimized atrial signal clarity for arrhythmia diagnosis.
  • BDxCONNECT Portal HIPAA-compliant, ISO/IEC 27001-certified web-based patient management portal that supports patient registration, secure cloud transmission of patch monitor data, EHR integration via API, automatic notifications and alerts, and physician-editable online reporting.
  • CAM Report Proprietary report format providing multiple diagnostic field views including Near-Field (8-second traditional view with R-R measurements), Medium-Field (56-second snapshot with 24 seconds pre/post episode), and Far-Field (40-minute R-R interval plot with 20 minutes pre/post) for enhanced arrhythmia diagnosis.
  • ECG Analysis and Reporting Services Professional ECG analysis services performed by CRAT- and CCT-certified ECG technicians, with CAM Reports prepared within 2 business days and practices retaining the option to perform analysis using their own in-house ECG technicians.

Quantifiable outcome

  • 96% of patients prefer CAM Patch over 3-lead standard Holter monitor
  • +4 more outcomes

Companies that use Bardy Diagnostics

Customer profile

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Bardy Diagnostics technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature5 records

Bardy Diagnostics partnerships and signals

Strategic signal

Partnerships

One partnership is on record.

  • Baxter International Inc.coreOthersBardy Diagnostics is now part of Baxter. The company operates as Bardy Diagnostics, Inc., a subsidiary of Baxter International Inc. All trademarks (BardyDx, Bardy Diagnostics, BDx Design, CAM) are owned by Baxter International Inc. or its subsidiaries. The redirect page confirms 'Bardy Diagnostics is now part of Baxter.'

Scale indicators7 records

Recent moves7 records

Expansion highlights5 records

Bardy Diagnostics competitors and assessment

Company assessment

Direct peers

  • iRhythm Technologies: Public competitor (Zio patch) and the most direct peer — Bardy explicitly benchmarks clinical performance against Zio XT in published head-to-head studies, with overlapping electrophysiologist and cardiologist customer base.
  • AliveCor: Maker of KardiaMobile ECG devices and AI-based AF detection algorithms; addresses the same electrophysiologist and cardiologist customer base for arrhythmia detection, though primarily via handheld/smartphone rather than patch form factor.

Emerging players

  • SmartCardia: Offers a 7-lead wearable ECG patch with AI-powered arrhythmia detection; competes in ambulatory cardiac monitoring with overlapping remote-monitoring use cases targeting similar cardiology customers.
  • HeartBeam: Developer of a credit-card-sized 3D ECG device for remote cardiac monitoring with AI-driven synthesis; competes in ambulatory arrhythmia detection with overlapping cardiology customer base.
  • Cardiac Insight: Developer of the Cardea SOLO wearable ECG sensor and AI-based arrhythmia analysis; smaller, earlier-stage competitor in the same ambulatory cardiac patch category with overlapping electrophysiologist customers.

Regional players

  • Compumedics: Australia-based developer of diagnostic ECG, Holter, and sleep monitoring systems; comparable in ambulatory cardiac monitoring hardware/services but primarily serves Asia-Pacific and select international markets rather than US focus of Bardy.

Broad incumbents

  • GE Healthcare (MUSE Cardiology): Provides ECG management systems, Holter analysis, and cardiac diagnostic infrastructure widely deployed in hospitals; competes indirectly via incumbent ECG analysis platforms that integrate with hospital cardiology workflows.
  • Boston Scientific (Preventice Solutions): Acquired Preventice Solutions (BodyGuardian) to enter remote cardiac monitoring; broader medtech incumbent now offering ambulatory ECG patch monitoring services directly competing with CAM Patch for cardiology accounts.
  • Philips (BioTelemetry/Cardiac Monitoring): Acquired BioTelemetry to offer a broad portfolio including MCT (mobile cardiac telemetry) and ECG monitoring services; competes in ambulatory cardiac monitoring space though as part of a much larger diagnostic and patient monitoring portfolio.
  • Hillrom / Baxter Patient Monitoring: Hillrom (now part of Baxter, parent of Bardy Diagnostics) provides Welch Allyn vital signs and bedside patient monitoring; potential channel partner and broader incumbent in hospital-based cardiac and patient monitoring.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Bardy Diagnostics social profiles

Digital presence

Bardy Diagnostics compliance and trust

Trust signal

Compliance2 records

Bardy Diagnostics financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Bardy Diagnostics leadership team

Management profile

Number of profiles

Profiles5 records

Bardy Diagnostics funding detail

Funding detail

Funding overview

Funding rounds4 records

Investors11 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Bardy Diagnostics M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Bardy Diagnostics

What does Bardy Diagnostics do?

Bardy Diagnostics develops, manufactures, and sells the Carnation Ambulatory Monitor (CAM) Patch, a single-use P-wave centric ECG patch monitor for up to 14 days of continuous ambulatory recording, paired with the BDxCONNECT cloud-based patient management portal and the proprietary multi-field CAM Report. Revenue is generated from CAM Patch device sales and associated ECG analysis and reporting services performed by certified technicians, with reimbursement under CPT codes for continuous cardiac monitoring ranging from 48 hours to 15 days.

Is Bardy Diagnostics a public or private company?

Bardy Diagnostics is a private company. It is classified as corporate owned and is currently operating.

When was Bardy Diagnostics founded?

Bardy Diagnostics was founded in 2013. It employs 11 to 50 people.

Where is Bardy Diagnostics based?

Bardy Diagnostics is headquartered in Seattle, United States, in the North America region.

How does Bardy Diagnostics make money?

Two revenue lines are on record. Ambulatory Cardiac Monitoring Services are the primary driver. The others are ECG Analysis and Reporting Services.

Who are Bardy Diagnostics's main competitors?

Direct peers on record are iRhythm Technologies and AliveCor. Emerging players are SmartCardia, HeartBeam and Cardiac Insight. Compumedics is listed as a regional player. Broad incumbents are GE Healthcare (MUSE Cardiology), Boston Scientific (Preventice Solutions), Philips (BioTelemetry/Cardiac Monitoring) and Hillrom / Baxter Patient Monitoring.

Does Bardy Diagnostics have an API?

No public API is recorded for Bardy Diagnostics.

What industry is Bardy Diagnostics in?

Bardy Diagnostics's product category is Ambulatory Cardiac Monitoring Devices. Its primary akta.pro industry code is HLAHACAB, Cardiac Monitoring (ECG/Holter/Event/Patch, Loop Recorders). Its NAICS code is 334510 and its SIC code is 3845.

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Live signals
DAICiRhythm Presents New Data on Ambulatory Cardiac MonitoringiRhythm Technologies presented data from the AVALON study at the Heart Rhythm Society’s annual meeting, demonstrating that its Zio long-term continuous monitoring service achieved higher diagnostic yields and lower rates of repeat testing and cardiovascular events compared to other ambulatory cardiac monitoring modalities in a commercially insured population. The analysis of 428,707 patients reinforced the clinical superiority of the Zio system over competitors such as Bardy, BioTelemetry, and Preventice, while also highlighting improved patient engagement through the MyZio app.DAICHuman ECG Monitoring Outperforms AI Dependent Remote Cardiac MonitoringA clinical trial presented at the Heart Rhythm 2021 meeting found that human-oversight dependent continuous ECG monitors detected significant arrhythmias with a 209% higher accuracy rate than AI-dependent mobile cardiac telemetry systems. The study compared Preventice BioGuardian MCT monitors against Bardy Carnation Ambulatory Monitors, revealing that algorithmic monitoring missed critical events in several patients that were correctly identified by human review.PR NewswireBardy Diagnostics Carnation Ambulatory Monitor Patch decreases both time to diagnosis and readmissions in Emergency Department patients with possible arrhythmia concerns in Clinical Study from OverlakA clinical study from Overlake Medical Center presented at the 2021 Heart Rhythm Society Conference found that Bardy Diagnostics' Carnation Ambulatory Monitor (CAM) patch reduced average time to diagnosis for emergency department patients with potential arrhythmias from 21 days to 7 days. The study of 412 patients over two years also showed that 30-day emergency department readmissions decreased dramatically from 40% to 7%. Bardy Diagnostics showcased the CAM patch technology at the conference, noting the monitoring solution generated new cardiology patient referrals, with 209 new patients referred to Overlake's cardiology department during the study period.PR NewswireHillrom Provides Update on Planned Acquisition of Bardy Diagnostics, Inc.Hillrom has asserted that a "Company Material Adverse Effect" has occurred under its acquisition agreement with Bardy Diagnostics, citing unexpected Medicare reimbursement rate reductions published by Novitas Solutions on January 29, 2021 for CPT codes related to long-term cardiac monitoring. BardyDx has responded by filing a complaint against Hillrom in the Delaware Court of Chancery, putting the deal's closing conditions in dispute. Hillrom states it remains committed to creating long-term shareholder value and will provide further updates as appropriate.PR NewswireHillrom Comments On Novitas Reimbursement DecisionHillrom announced it is assessing a recent reimbursement rate decision by Medicare Administrative Contractor Novitas Solutions, which published new Category 1 reimbursement rates for extended Holter cardiac monitoring CPT codes on January 29, 2021. The new rates apply to CPT codes 93241, 93243, 93245, and 93247, which are relevant to Hillrom's pending acquisition of Bardy Diagnostics. Hillrom stated it is monitoring the fluid situation and cannot provide further comment at this time, while reaffirming its commitment to creating long-term shareholder value.PR NewswireBardy Diagnostics® Announces CE Mark Certification for 14-Day Carnation® Ambulatory Monitor (CAM®) Patch in Europe and Expansion of Home Enrollment Program Amidst COVID-19 CrisisBardy Diagnostics received CE mark certification for its 14-Day Carnation Ambulatory Monitor (CAM) patch, expanding its market access in Europe alongside existing U.S. and Canadian clearances. The company also announced the expansion of its Home Enrollment Program to facilitate remote patient monitoring and reduce exposure risks during the COVID-19 pandemic.PR NewswireBardy Diagnostics™ Names Ed Vertatschitsch as Chief Operating Officer and Announces Additions to the Leadership TeamBardy Diagnostics announced the appointment of Ed Vertatschitsch as Chief Operating Officer effective January 2, 2020, along with additional leadership team additions including Cristina Gutierrez as VP of Market Development & Training, Liz Mynhier promoted to VP of Clinical Services & Customer Experience, and Brit Baird promoted to VP of Regulatory Affairs & Quality Assurance. Vertatschitsch brings over 17 years of medical device industry experience from roles at Varian Medical Systems and Calypso Medical, where he served as President and CEO. The company stated it is experiencing accelerating growth with the success of its Carnation Ambulatory Monitor patch and expansion of its ECG analysis technologies.PR NewswireBardy Diagnostics™ Wins the Remote Monitoring in Arrhythmias Digital Health Pitch Session at European Society of Cardiology Congress 2019 and Presents at UK Heart Rhythm Congress 2019Bardy Diagnostics, Inc. won the Remote Monitoring in Arrhythmias Technology and Innovation Pitch Session at the European Society of Cardiology Congress 2019 in Paris for its P-wave centric Carnation Ambulatory Monitor. The company's founder and CEO Dr. Gust H. Bardy also presented at the Heart Rhythm Congress 2019 in Birmingham, UK, highlighting the importance of high-fidelity ECG tracings in arrhythmia diagnosis. The CAM patch recently received FDA 510(k) clearance to extend monitoring duration to 14 days and has won multiple industry awards including the MedTech Breakthrough Award and Frost & Sullivan Award.PR NewswireBardy Diagnostics™ Receives FDA 510(k) Clearance for 14-Day Carnation Ambulatory Monitor (CAM) PatchBardy Diagnostics, Inc. announced it received 510(k) clearance from the U.S. Food and Drug Administration for a 14-day extended wear version of its Carnation Ambulatory Monitor patch, expanding beyond its existing 2-Day and 7-Day product lines. The P-wave centric cardiac monitoring device demonstrated 40% higher arrhythmia detection compared to the iRhythm Zio XT patch in a peer-reviewed study and four times the detection rate of traditional Holter monitors. The company, which has won multiple industry awards including the 2019 MedTech Breakthrough Award and 2019 Frost & Sullivan Award, expects the longer monitoring duration to improve diagnostic accuracy and reduce reliance on additional diagnostic tools.PR NewswireBardy Diagnostics™ Selected As Finalist For Two MedTech Insight Awards To Be Announced At AdvaMed's Annual MedTech ConferenceBardy Diagnostics, Inc. (BardyDx) was selected as a finalist in two categories for the 2nd Annual Medtech Insight Awards: "Best Technical Innovation: Diagnostics" and "Best Proof-of-Value of an Innovation." The recognition highlights the company's Carnation Ambulatory Monitor (CAM), a P-wave centric ambulatory cardiac patch monitoring device, with winners to be announced on September 23, 2019 in Boston, MA. The company stated this adds to its growing list of industry recognitions, including the 2019 MedTech Breakthrough Award and the 2019 Frost & Sullivan Award.