Roundup: Bluetooth Medical Devices Cleared by FDA in 2023

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.

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1/11/2023

Dexcom receives 510(k) for G6 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.

1/18/2023

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.

1/23/2023

Tidepool receives 510(k) for 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.

2/3/2023

Acurable receives 510(k) for 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.

2/6/2023

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.

2/8/2023

Adherium receives 510(k) for 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.

2/20/2023

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.

3/6/2023

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

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.

3/8/2023

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.

3/8/2023

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.

3/9/2023

Neuro20 receives 510(k) for 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.

3/8/2023

Masimo receives De Novo for 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.

4/24/2023

Casana receives 510(k) for the Heart 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.

4/21/2023

Medtronic receives 510(k) for 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.

5/5/2023

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).

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