Roundup: Bluetooth Medical Devices Cleared by FDA in 2023

Randy Horton
Randy Horton

Bluetooth technology makes connected medical devices more powerful, more sophisticated and easier to use, helping MedTech companies to improve patient outcomes faster. It allows developers to offload processing power to patients’ smartphones, facilitates the automatic transfer of data from the medical device to a clinician portal or cloud database, and lets patients adjust treatment through their personal smart devices.

With all the benefits Bluetooth provides, it’s no surprise that many FDA-cleared medical devices incorporate it into their systems. What Bluetooth-enabled medical devices have received FDA clearance so far in 2023? This blog lists the devices that have had their clearance made public and describes how they use Bluetooth.



Dexcom receives 510(k) for G6 CGM

Dexcom G6 Continuous Glucose Monitoring System (CGM)


The Dexcom G6 Continuous Glucose Monitoring System (CGM) is an interoperable connected device that measures and displays glucose values for patients with diabetes. It uses BLE to transmit data from the sensor/applicator to a BLE-enabled display device, either a receiver or a mobile application. Dexcom received clearance for their G7 CGM last December. This filing for the previous model includes an alternate receiver to bring it in line with the G7.



Signifier Medical Technologies receives 510(k) for eXciteOSA



eXciteOSA is a removable muscle stimulator that delivers neuromuscular stimulation to the tongue to relieve symptoms of obstructive sleep apnea. It uses Bluetooth to communicate with a smartphone app that controls the device. This device had already received clearance, with a contraindication for people with metal implants in their mouth. Signifier Medical Technologies has since conducted an observational study that demonstrated no significant difference in side effects for people with and without metal dental work. This new filing removes the contraindication.



Tidepool receives 510(k) for Tidepool Loop

Tidepool Loop


Tidepool Loop is a fully interoperable solution for Type 1 diabetes management. It uses Bluetooth to communicate with any compatible integrated CGM or alternate controller enabled insulin infusion pump.



Acurable receives 510(k) for AcuPebble Ox100

AcuPebble Ox100


Acurable’s AcuPebble Ox100 is a wearable device that records, analyses, displays, exports and stores biophysical parameters that aid in diagnosing sleep apnea. Bluetooth communication is used between the sensor in the device and the AcuPebble companion mobile app.



Vivify Health receives 510(k) for Care Team Portal

Vivify Health is a platform for remote patient monitoring. This clearance is specifically for the platform’s clinician portal. Like many health portals, it allows clinicians to view and manage patient information, schedule video visits and send secure messages, among other things. Patient data can be collected wirelessly over Bluetooth and sent to the portal.



Adherium receives 510(k) for Hailie Sensor NF0110

Hailie Sensor NF0110


Hailie Sensor NF0110 is an electronic data capture accessory that remotely monitors patients who use compatible inhalers. This clearance is specifically to add functionality for Teva HFA pressurized metered dose inhalers. Adherium has already received clearance for compatibility with AstraZeneca and GSK inhalers. The Hailie sensor has a Bluetooth interface to wirelessly exchange medication usage data with a paired communications device and compatible mobile software applications.



Perifit receives 510(k) for Perifit connected device system



Perifit is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening the pelvic floor muscles through exercise. The device provides biofeedback to a companion smart phone app over Bluetooth.



Abbott Diabetes Care receives 510(k) for FreeStyle Libre 2 Flash Glucose Monitoring System and FreeStyle Libre 3 Continuous Glucose Monitoring System

Abbott Diabetes Care


These diabetes monitoring devices from Abbott received new clearance that allows for connectivity with automated insulin delivery (AID) systems. Both systems autonomously communicate with digitally connected devices over Bluetooth.

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Respiree receives 510(k) for RS001 Cardio-Respiratory Wearable



From Digital Therapeutics company Respiree, the RS001 is a chest wearable that measures respiration directly. It can be used on patients suffering from cardio-pulmonary diseases such as chronic obstructive pulmonary disease (COPD) and congestive heart failure. It uses Bluetooth to wirelessly transfer patient data to mobile devices.



Neuromod receives De Novo for Lenire Tinnitus Treatment Device



Neuromod’s Lenire is a non-invasive treatment device for tinnitus. It combines acoustic and electrical intraoral stimulation to relieve tinnitus pain. The Lenire system includes Bluetooth headphones that connect wirelessly to a handheld controller.



Neuro20 receives 510(k) for Neuro20 Pro System

Neuro20 Pro System


The Neuro20 Pro System is a bodysuit that stimulates muscles to improve or facilitate muscle performance. It has a variety of uses, including retraining muscles after an injury and maintaining or increasing range of motion. The device control unit generates and transmits electrical signals to the electrodes in the suit via Bluetooth.



Masimo receives De Novo for Opioid Halo

Opioid Halo


Masimo’s Opioid Halo is a system that detects opioid-induced respiratory depression, the direct cause of death from opioid overdose. It features a tetherless, adhesive fingertip sensor and a reusable Masimo SET pulse oximeter and Bluetooth chip.



Casana receives 510(k) for the Heart Seat

Casana Smart Toilet Seat


Your eyes aren’t fooling you. Casana’s medical device is a smart toilet seat that remotely monitors heart rate and oxygen saturation when it is sat on by a patient. It sends health data to providers over Bluetooth, and notifies them when parameters are outside of a set threshold.



Medtronic receives 510(k) for MiniMed 770G

Medtronic MiniMed 770G


The Medtronic MiniMed 770G is a closed-loop system for diabetes management. This clearance enables the firmware over-the-air update feature. With this feature, Medtronic can distribute wireless firmware updates over Bluetooth to upgrade patients’ insulin pumps without the need for the pump to be returned. It also allows 770G users to upgrade their pump firmware to the recently approved 780G firmware, which adds new features.



DynamiCare receives Breakthrough Device Designation for DCH-002

DyanmiCare’s DCH-002 is a Digital Therapeutic intended to treat alcohol use disorder. It combines a smartphone app with a Bluetooth-connected, police-grade breathalyzer and a reloadable, risk-protective smart debit card. Participants complete random breath tests, and if they test negative, they are awarded a cash reward on their smart debit card (which blocks access to bars, liquor stores and cash withdrawals).


Looking for a partner to develop your Bluetooth enabled medical device? Orthogonal’s extensive library of edge cases, testing methods and mitigations will help you get the most out of Bluetooth communication for connected medical devices.

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