Secure & Reliable Firmware for Connected Devices

BACtrack was the first company the FDA allowed to market breathalyzers for consumer use, and in 2013 it released the world’s first smartphone breathalyzer.

BACtrack Mobile pairs with a phone over Bluetooth, turning a breath sample into a blood alcohol estimate on the screen in the person’s hand.

That means anyone can know their number before making a decision that depends on it. It also means an accuracy people stake real decisions on has to survive a wireless link to whatever phone they happen to carry.

Cardiac ablation treats rhythm disorders by delivering energy through a catheter to precise points inside the heart.

A cardiac ablation company is building a new system in which each catheter handle stores its own calibration and log data.

For the electrophysiologist, that means each catheter brings its own calibration to the system before energy is delivered. It also means data that gates a high-energy therapy has to read correctly every time.

CLiC™ is Cardinal IG’s smart privacy glass, and after more than ten years of development it entered full-scale production in 2026.

A pane switches from clear to private in under a tenth of a second, with no tint or distortion, and ties into smart home and building control systems.

For a home or a hospital room, that means privacy on command with no blinds or drapes. It also means a window that is now a connected device, one that has to stay secure and keep working for as long as the glass does, and be built the same way for every manufacturer who puts it into a window, glass door, or glass partition.

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.

Envoy built the first FDA-approved hearing device that lives entirely inside the body.

The Acclaim™ Cochlear Implant is designed for severe hearing loss, with a sensor that uses the ear’s own anatomy to capture sound in place of an external microphone.

There is nothing to take off before sleeping or showering. There is also nothing easy to power, charge, or connect, and the parts other implants keep outside the head are sealed inside, out of reach without surgery.

In cardiac arrest, survival depends on a defibrillator working the instant a care team reaches for it.

A global acute care company is building wireless connectivity into its next generation of defibrillators, with the security architecture to protect it.

For a care team, that means the data a defibrillator gathers can move with a patient, without a cable. It also means a wireless path into a device that delivers a shock, where security can never slow it down.

Whether a narrowed coronary artery gets a stent often comes down to a pressure reading taken across the blockage mid-procedure.

A global cardiovascular device company makes one of the systems that delivers it, in cath labs worldwide, and is bringing its wireless link and security to a new generation.

For the cardiologist, that means a stent decision based on how blood actually flows. It also means replacing the wireless link and its security on a system already in cath labs, while the measurement stays the same.

A global fashion brand’s smartwatches reached millions of wrists across several product generations, and they were designed to look like watches first.

Under the face they tracked health and activity, moved logs and firmware updates to a phone over Bluetooth, and ran on a battery sized for a fashion case.

For the wearer, that meant a watch chosen for how it looked that still did what a smartwatch does. It also meant pairing with every phone and OS version its wearers owned, each handling Bluetooth its own way, at a scale where a one-in-a-million quirk came up every day.

Hyperice’s Core™ Meditation Trainer is a handheld device you cup in both palms, with heart sensors in the handles and a pulse you breathe along with.

It reads heart rate and heart rate variability to tell when you have settled into a focused state, and the app’s guided sessions respond to that.

For someone who wonders whether they are meditating right, that means a device that can tell them. It also means a consumer product whose first act out of the box is updating its own firmware over Bluetooth, in a living room, where a failed update is a returned product.

Inspire® is the first FDA-approved neurostimulation therapy for moderate to severe obstructive sleep apnea.

A small implant stimulates the nerve that controls the tongue in time with the patient’s breathing, and a connected system sits around it, with a Bluetooth remote the patient holds, an app, and a clinician web portal that monitors the implant wirelessly.

For someone who could never live with a mask, that means sleeping with nothing on their face and starting therapy with a click. It also means the system around a Class III implant has moved through several device generations while every implant already placed stays in a body for years, so no part of the system can change without accounting for every implant in the field.

Kiddo began at GoodParents as a wristband for children ages 4 to 10, built to give parents real-time insight into their child’s health and wellbeing.

The band reads temperature, perspiration, heart rate, and motion, and the parent app turns those readings into scores for health, activity, sleep, and emotional wellbeing.

That means a parent sees how their child is sleeping and coping, along with how active they are. It also means sensors on a small child’s wrist, worn through play and sleep, have to read steadily enough to become a score a parent can trust.

Portal Diabetes holds FDA Breakthrough Device designation for the Portal Pump™, an implantable insulin delivery system.

The pump is designed to sit in the abdomen, dose from a continuous glucose monitor with a heat-stable concentrated insulin, and take refills in a clinic after weeks or months.

For someone with type 1 diabetes, that means no carbohydrate counting, no meal announcements, and no waking in the night. It also means a loop that closes with no one in it, which has to be trusted before it is ever implanted and then stays in for five to seven years.

A stealth-stage medical startup is developing an implanted neuromodulation therapy that its clinicians can adjust without the patient in the room.

For the patient, that means a therapy that changes when it needs to instead of at the next appointment.

It also means every adjustment travels from a clinician’s screen to a device inside someone’s body, and that path has to be trusted at Class III stakes before anything is implanted.

Synchron ran the first FDA-approved clinical trial of a permanently implanted brain-computer interface, and all six patients met the primary safety endpoint.

The Stentrode® is placed through a blood vessel, with no open brain surgery, and sits in a vein beside the motor cortex reading the intent to move.

For someone with severe paralysis, that means texting, browsing, and opening apps by thought alone. It also means the connection out of the body is the whole product, at Class III stakes. Nothing the implant does reaches a screen unless that link holds.

In CT and MRI, the contrast injector sits beside the patient while the technologist runs the scan from a control room next door.

Control from that room is common, but it usually means running cable through the wall. A global radiology company asked whether wireless could replace it.

For an imaging department, that means installing an injector without new cable through the shielding. It also means a command that starts contrast flowing has to work in every facility, and the program had to show where it could.