Connected In-Clinic Devices
Engineered for FDA Clearance & Hospital Deployment
From procedure-enabling devices to clinical diagnostic systems, we design every layer of the connected system, so the same engineering satisfies the submission and the hospital review.
What Sets Us Apart
The Connected In-Clinic System
An In-Clinic Device Is One Component of a Five-Layer System Inside the Hospital
WHAT WE SOLVE FOR
Clinical Device Programs Break Down in Predictable Places
We’ve built across enough in-clinic programs to recognize where the clinical environment creates risk. These are the program-level problems we solve.
Wireless Works in the Lab and Fails in the Hospital
The Device Fleet Can't Be Managed Remotely
Clinical Engineering Rejects the Network Architecture
Hospital IT Security Blocks Deployment
Workflow Integration Treated as a UX Problem
Verification That Ignores Clinical Use Conditions
Regulatory & Compliance
The Submission and the Hospital Review Evaluate the Same System
FDA PATHWAY
Design Controls Run Through Every Discipline
IEC 62304 and ISO 14971 govern how our firmware, mobile, and cloud engineers work, so requirements trace to tests, risk controls trace to design decisions, and the design history file reflects what was actually built. Section 524B cybersecurity documentation comes out of the same process.
Hospital Readiness
Hospital Requirements Enter the Architecture Early
MDS2 disclosure, HIPAA data handling, and EHR and PACS integration are design inputs when we architect the network and cloud layers.
The evidence clinical engineering and IT security ask for exists because the system was built to produce it.
Every requirement engineered into the architecture.
for Class II devices
for novel low-to-moderate-risk devices
for Class III devices
for clinical investigation of an unapproved device
as a premarket submission requirement under FDA's February 2026 final guidance
for system-level threat modeling and architecture decisions
at the connectivity and software level
Security across the health software lifecycle
Medical Device Software Lifecycle
Risk Management
Quality Management System Regulation
Quality Management
Basic Safety and Essential Performance
and Design Input/Output Documentation
for BLE and Wi-Fi
for Wireless Medical Devices
International Certifications
Wireless Coexistence
Clinical messaging with hospital information systems
EHR data exchange
Imaging system integration
Manufacturer disclosure for hospital security review
Patient Data Privacy
Compliance Frameworks
for Healthcare Applications
Clinical Domains
We've Built Connected In-Clinic Systems Across the Clinical Landscape.
That landscape runs from procedural devices in the cath lab to the treatment, programming, and fitting systems clinicians use in the clinic. Every domain below is grounded in delivered programs.
Implant Programming Systems
Cochlear Implant Fitting Systems
Cath Lab & Cardiac Assessment Systems
Connected Clinical Treatment Devices
Respiratory Therapy Devices
Surgical Setup & Fitting Systems
Neuromodulation Clinical Systems
Contrast Injection Systems
In-Clinic Programs We've Been Trusted With.
We’re drawn to the hard problems, and these are a few of the complex connected in-clinic systems we’ve helped build.
A Connected Docking Station for Clinical Microneedling Devices
DermapenWorld’s Dp4™ microneedling pens are used in clinics around the world, all kept current through a companion app.
The Dp DOCK™ is where a pen sits between treatments. It syncs the pen to the app, installs firmware updates, watches its battery, and will not let it be stored with a needle cartridge attached.
For a practitioner, that means a pen that is current and ready for the next treatment without anyone thinking about it. It also means a dock that has to work with every version of the pen and app in the field, in a clinic where it will never get a second look.
Next-Generation Remote Management for a Cath Lab Device System
One in four angiography patients has chronic kidney disease, and the contrast dye that makes the procedure possible is hard on the kidneys.
Osprey Medical’s FDA-cleared DyeVert™ PLUS diverts part of the dye before it reaches the patient, cutting the amount delivered by about 40 percent with no loss of image quality, and tracks each patient’s cumulative dose against their kidney function in real time.
For those patients, that means a heart procedure with less risk of kidney injury. It also means a tablet talking wirelessly to bedside devices inside a cath lab, one of the noisiest radio environments in a hospital, where nothing can drop mid-procedure.
A Non-Invasive Cardiac Assessment Platform for Clinical Studies
Knowing how well a failing heart is pumping usually takes an echocardiogram and a trained operator, or a catheter threaded into the heart.
Sensydia’s Cardiac Performance System reads ejection fraction, cardiac output, and pulmonary artery pressure from disposable sensors on the chest, in minutes, at the bedside. Its ejection fraction measurement was first FDA-cleared in 2018, and the full platform holds Breakthrough Device Designation.
For a patient in an ICU or emergency department, that means answers without a referral or a procedure. It also means one measurement running across sensors, a gateway, a tablet, and the cloud, carrying patient data the whole way, while the platform is still being proven in clinical studies.
A Connected Docking Station for Clinical Microneedling Devices
Next-Generation Remote Management for a Cath Lab Device System
A Non-Invasive Cardiac Assessment Platform for Clinical Studies
A Connected Docking Station for Clinical Microneedling Devices
DermapenWorld’s Dp4™ microneedling pens are used in clinics around the world, all kept current through a companion app.
The Dp DOCK™ is where a pen sits between treatments. It syncs the pen to the app, installs firmware updates, watches its battery, and will not let it be stored with a needle cartridge attached.
For a practitioner, that means a pen that is current and ready for the next treatment without anyone thinking about it. It also means a dock that has to work with every version of the pen and app in the field, in a clinic where it will never get a second look.
Next-Generation Remote Management for a Cath Lab Device System
One in four angiography patients has chronic kidney disease, and the contrast dye that makes the procedure possible is hard on the kidneys.
Osprey Medical’s FDA-cleared DyeVert™ PLUS diverts part of the dye before it reaches the patient, cutting the amount delivered by about 40 percent with no loss of image quality, and tracks each patient’s cumulative dose against their kidney function in real time.
For those patients, that means a heart procedure with less risk of kidney injury. It also means a tablet talking wirelessly to bedside devices inside a cath lab, one of the noisiest radio environments in a hospital, where nothing can drop mid-procedure.
A Non-Invasive Cardiac Assessment Platform for Clinical Studies
Knowing how well a failing heart is pumping usually takes an echocardiogram and a trained operator, or a catheter threaded into the heart.
Sensydia’s Cardiac Performance System reads ejection fraction, cardiac output, and pulmonary artery pressure from disposable sensors on the chest, in minutes, at the bedside. Its ejection fraction measurement was first FDA-cleared in 2018, and the full platform holds Breakthrough Device Designation.
For a patient in an ICU or emergency department, that means answers without a referral or a procedure. It also means one measurement running across sensors, a gateway, a tablet, and the cloud, carrying patient data the whole way, while the platform is still being proven in clinical studies.
Connected Medical Systems, Engineered As One.
Our latest thinking on connected medical device development.
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