. 2021 Jun 13;16(1):168–214. doi: 10.1177/19322968211007212

Table 1.

Regulatory Features of NIO-GM, NIFS-GM, or MI-GM Identified Products (in Alphabetical Order Within Each Category of Invasiveness).

Entry number	Product and manufacturer	Degree of invasiveness	Headquarter country	Which inclusion criteria were met	PubMedarticle	Regulatory status	Adjunctive or non-adjunctive (if cleared by the FDA)
1	No product name; Afon Technology	NIO-GM	Wales	Google News⁸⁵	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.^85,86	N/A
2	Alertgy NI-GM; Alertgy	NIO-GM	USA	Google News⁸⁷	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.⁸⁸	N/A
3	No product name; AnnNIGM	NIO-GM	Russia	Google News⁸⁹	None	Not cleared by FDA and has not received CE Mark of approval. No patent identified.	N/A
4	Add on to the Apple Watch; Apple	NIO-GM	USA	Google News⁹⁰	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.^90,91	N/A
5	BioMKR; Prediktor Medical	NIO-GM	Norway	Google News⁹²	None	Not cleared by FDA and has not received CE Mark of approval. Patent pending.⁹³	N/A
6	Blood Analysis Sensor; Brolis Sensor Technology	NIO-GM	Lithuania	Google News⁹⁴	None	Not cleared by FDA and has not received CE Mark of approval. Patent pending.⁹⁵	N/A
7	CompanionCM; Socrates Health Solutions	NIO-GM	USA	Google News⁹⁶	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.^97,98	N/A
8	CompanionSR; Socrates Health Solutions	NIO-GM	USA	Google News⁹⁶	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.^97,98	N/A
9	D-Band; DiaMonTech	NIO-GM	Germany	Google News⁹⁹	Lubinski¹⁰⁰	Not cleared by FDA but the manufacturer has submitted a pre-submission to the FDA for the D-Base to the FDA.¹⁰¹ Has not received CE Mark of approval. Patented technology.^102,103	N/A
10	D-Base; DiaMonTech	NIO-GM	Germany	Google News⁹⁹	Lubinski¹⁰⁰	Not cleared by FDA and has not received CE Mark of approval. Patented technology.^102,103	N/A
11	D-Pocket; DiaMonTech	NIO-GM	Germany	Google News⁹⁹	Lubinski¹⁰⁰	Not cleared by FDA and has not received CE Mark of approval. Patented technology.^102,103	N/A
12	GlucoBeam; RSP Systems	NIO-GM	Denmark	Google News¹⁰⁴	Pleus¹⁰⁵	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹⁰⁶	N/A
13	GlucoFit; GlucoActive	NIO-GM	Poland	Google News¹⁰⁷	None	Not cleared by FDA and has not received CE Mark of approval. No patent identified.	N/A
14	Gluco Quantum; Genki Vantage Ltd	NIO-GM	China	Google News¹⁰⁸	None	Not cleared by FDA and has not received CE Mark of approval. Has not received CE Mark of approval but has initiated ISO 13485 certification process. Patented technology.^109,110	N/A
15	Glucosense; Glucosense Diagnostics Ltd	NIO-GM	England	Google News¹¹¹	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹¹²	N/A
16	GlucoStation; GlucoActive	NIO-GM	Poland	Google News¹¹³	None	Not cleared by FDA and has not received CE Mark of approval. No patent identified.	N/A
17	GlucoTrack; Integrity Applications Ltd	NIO-GM	Israel	Google News,¹¹⁴ CE Mark¹¹⁵	Lin¹¹⁶	Not cleared by FDA. Received the CE Mark of approval June 2013 for DF-F model. Received final CE Mark of approval in March 2014.¹¹⁵	N/A
18	GlucoWear; GlucoActive	NIO-GM	Poland	Google News¹⁰⁷	None	Not cleared by FDA and has not received CE Mark of approval. No patent identified.	N/A
19	GlucoWise; MediWiSe	NIO-GM	England	Google News¹¹¹	Gonzales⁵	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹¹⁷	N/A
20	Glutrac; Add Care Ltd	NIO-GM	China	Google News¹¹⁸	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹¹⁹	N/A
21	HELO Extense; Wor(l)d Master Distributors	NIO-GM	USA	Google News¹²⁰	Gonzales⁵	Not cleared by FDA and has not received CE Mark of approval. Patent pending.^121,122	N/A
22	HELO LX PRO; Wor(l)d Master Distributors	NIO-GM	USA	Google News¹²⁰	None	Not cleared by FDA and has not received CE Mark of approval. Patent pending.^121,122	N/A
23	LIFELEAF; LifePlus	NIO-GM	USA	Google News¹²³	None	Not cleared by FDA and has not received CE Mark of approval. Patent pending.¹²⁴	N/A
24	Movano Wearable CGM; Movano	NIO-GM	USA	Google News¹²⁵	None	Not cleared by FDA and has not received CE Mark of approval. Patent pending.¹²⁶	N/A
25	No product name; Omni Sciences, Inc.	NIO-GM	USA	Google News¹²⁷	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.^90,128	N/A
26	Sanmina; Sanmina Corporation	NIO-GM	USA	Google News¹²⁹	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹³⁰	N/A
27	TensorTip Combo Glucometer; Cnoga Medical Ltd	NIO-GM	Israel	Google News,¹³¹ CE Mark¹³²	Pfützner¹³³	Not cleared by FDA. Received the CE Mark of Approval.¹³²	N/A
28	Uband; Know Labs, Inc.	NIO-GM	USA	Google News¹³⁴	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹³⁵	N/A
29	Bios; GraphWear Technologies Inc.	NIFS-GM	USA	Google News⁸⁹	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹³⁶	N/A
30	gSense; Nutrix	NIFS-GM	Switzerland	Google News¹³⁷	None	Not cleared by FDA and has not received CE Mark of approval. No patent identified.	N/A
31	NextGen CGM; Echo Therapeutics	NIFS-GM	USA	Google News⁸⁹	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹³⁸	N/A
32	Saliva Glucose Biosensor; Gbs Inc.	NIFS-GM	USA	Google News¹³⁹	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹⁴⁰	N/A
33	sugarBEAT; Nemaura Medical	NIFS-GM	USA	Google News,¹⁴¹ CE Mark¹⁴²	Gonzales⁵	Has received CE Mark of Approval.¹⁴² Submitted a premarket approval medical device application to the FDA for its SugarBEAT glucose monitor.¹⁴³	N/A
34	Tear Glucose Sensor; NovioSense	NIFS-GM	Netherlands	Google News¹⁴⁴	Geelhoed-Duijvestijn¹⁴⁵	Not cleared by FDA and has not received CE Mark of approval. Patented technology.³⁶	N/A
35	AiDex CGM; GlucoRx (Rebranding of MicroTech Medical)^146,147	MI-GM	England	Google News⁸⁹	None	Not cleared by FDA and has not received CE Mark of approval. No patent identified.	N/A
36	Biolinq CGM; Biolinq	MI-GM	USA	Google News¹⁴⁸	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹⁴⁹	N/A
37	Care Sense Air; i-SENS	MI-GM	South Korea	Google News⁸⁹	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹⁵⁰	N/A
38	Cascade CGM system; Waveform	MI-GM	USA	Google News, CE Mark¹⁵¹	Rebec¹⁵²	Not cleared by FDA. Received CE Mark of approval in 2019 and usable for people who are over 2 years of age¹⁵¹	N/A
39	CT-100; POCTech X Ascensia	MI-GM	POCTech: China Ascensia: Switzerland	Google News,¹⁵³ CE Mark¹⁵⁴	None	Not cleared by FDA. Received CE Mark of approval.¹⁵²	N/A
40	Dexcom G6; Dexcom	MI-GM	USA	Google News,¹⁵⁵ FDA cleared,¹⁵⁶ CE Mark¹⁵⁷	Isaacson¹⁵⁸	Cleared by the FDA in October, 2019 for use in adults and children over 2 years of age.¹⁵⁶ Received CE Mark of approval in 2020.¹⁵⁷	Non-adjunctive¹⁵⁹
41	Dexcom G7; Dexcom	MI-GM	USA	Google News¹⁶⁰	None	Not cleared by FDA and has not received CE Mark of approval. No patent identified.	N/A
42	Eclipse 3; iCGM GlySens	Implanted MI-GM	USA	Google News¹⁶¹	None	Not cleared by FDA and has not received CE Mark of approval. Patent pending.¹⁶²	N/A
43	Eversense; Senseonics	Implanted MI-GM	USA	Google News,¹⁶³ FDA cleared,¹⁶⁴ CE Mark¹⁶⁵	Fokkert¹⁶⁶	Cleared by the FDA for people who are over 18 years of age.¹⁶⁴ Received CE Mark of approval in 2016.¹⁶⁵	Non-adjunctive¹⁶⁷
44	FiberSense Technology CGM; EyeSense	MI-GM	Switzerland	Google News⁹⁰ (manufacturer is mentioned)	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹⁶⁸	N/A
45	FreeStyle Libre 14 day; Abbott Diabetes Care	MI-GM	USA	Google News,¹⁶⁹ FDA cleared,¹⁷⁰ CE Mark¹⁷¹	Kudva¹⁷²	Cleared by the FDA.¹⁷⁰ Received CE Mark of approval in 2014.¹⁷¹	Non-adjunctive¹⁷³
46	FreeStyle Libre 2; Abbott Diabetes Care	MI-GM	USA	Google News,¹⁷⁴ FDA cleared,¹⁷⁵ CE Mark¹⁷⁶	Denham¹⁷⁷	Cleared by the FDA for adults and children with diabetes ages 4 years and above.¹⁷⁵ Received CE Mark of approval in 2018.¹⁷⁶	Non-adjunctive¹⁷⁸
47	FreeStyle Libre 3; Abbott Diabetes Care	MI-GM	USA	Google News,¹⁷⁹ CE Mark¹⁷⁹	O’Neill¹⁸⁰	Not cleared by the FDA. Has received CE Mark of approval for adults and children with diabetes ages 4 years and above.¹⁷⁹	N/A
48	Glucomen Day CGM; A. Menarini Diagnostics	MI-GM	Italy	Google News,¹⁸¹ CE Mark¹⁸²	O’Neill¹⁸⁰	Not cleared by the FDA. Waveform partner received CE Mark of approval to release Glucomen day.¹⁸²	N/A
49	Glunovo i3 CGM; Infinovo Medical Co Ltd.	MI-GM	China	Google News,¹⁸³ CE Mark¹⁸⁴	None	No news articles about Infinovo CE Mark. However, LinkedIn page of Infinovo indicates CE Mark has been received as of June 2019.¹⁸⁴	N/A
50	Glyde CGM; GluSense	Implanted MI-GM	Israel	Google News¹⁸⁵	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹⁸⁶	N/A
51	Indigo CGM; Indigo	Implanted MI-GM	Belgium	Google News¹⁸⁷	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹⁸⁸	N/A
52	No product name; Integrated Medical Sensors	Implanted MI-GM	USA	Google News¹⁸⁹	Mujeeb-U-Rahman¹⁹⁰	Not cleared by FDA and has not received CE Mark of approval. Patent pending.¹⁹¹	N/A
53	No product name; One Drop (acquired Sano Intelligence, Inc., which was developing patch biosensor glucose monitor)¹⁹²	MI-GM	USA	Google News¹⁹³	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.¹⁹⁴	N/A
54	K’Watch; PKvitality	MI-GM	France	Google News¹⁹⁵	Gonzales⁵	Not cleared by FDA and has not received CE Mark of approval. Patented technology.^196,197	N/A
55	Lumee; Profusa	Implanted MI-GM	USA	Google News⁸⁹	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.^198,199	N/A
56	Medtronic Guardian Connect (Powered by Medtronic Guardian Sensor 3); Medtronic MiniMed	MI-GM	USA	Google News,²⁰⁰ FDA cleared,²⁰¹ CE Mark²⁰²	Sadhu²⁰³	FDA has approved the Android version of its guardian connect system.²⁰¹ Received CE Mark of approval in 2016.²⁰²	Adjunctive²⁰⁴
57	Medtronic Synergy; Medtronic MiniMed	MI-GM	USA	Google News²⁰⁵	None	Not cleared by FDA and has not received CE Mark of approval. No patents identified.	N/A
58	Medtronic Zeus; Medtronic MiniMed	MI-GM	USA	Google News²⁰⁵	None	Not cleared by FDA and has not received CE Mark of approval. No patents identified.	N/A
59	No product name; Metronom Health	MI-GM	USA and Belgium	Google News⁸⁹	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.^206,207	N/A
60	PercuSense CGM; PercuSense	MI-GM	USA	Google News²⁰⁸	None	Not cleared by FDA and has not received CE Mark of approval. Patent pending.²⁰⁹	N/A
61	Sanvita CGM; Sanvita Medical, LLC and LifeScan	MI-GM	Sanvita Medical, LLC: USA Lifescan: USA	Google News²¹⁰	None	Not cleared by FDA and has not received CE Mark of approval. Patent pending.²¹¹	N/A
62	Sencell; Lifecare AS	MI-GM	Norway	Google News²¹²	None	Not cleared by FDA and has not received CE Mark of approval. Patented technology.²¹³	N/A
63	SugarSenz; Glucovation	MI-GM	USA	Google News²¹⁴	None	Not cleared by FDA and has not received CE Mark of approval. Patent pending.²¹⁵	N/A
64	SynerG; Pacific Diabetes Technologies	MI-GM	USA	Google News²¹⁶	Jacobs²¹⁷	Not cleared by FDA and has not received CE Mark of approval. Patented technology.²¹⁸	N/A
65	TouchCare System A6; Medtrum	MI-GM	China	Google News⁸⁹	Zhou²¹⁹	Not cleared by FDA and has not received CE Mark of approval. Patented technology.²²⁰	N/A

PubMed article refers to the first author of an article indexed in the PubMed database. Abbreviations: CE, Conformité Européenne; FDA, United States Food and Drug Administration; MI-GM, minimally invasive glucose monitor; NIFS-GM, noninvasive fluid sampling glucose monitor; NIO-GM, noninvasive optical glucose monitor; USA, United States of America.