Innovative Devices for Unmet Needs
The Food and Drug Administration (FDA) has made a positive decision on the marketing applications of the following products. What sets them apart? They are innovative devices that qualified and participated in FDA’s Breakthough Products program.
Read more about FDA’s Breakthrough Products Program.
FDA Breakthrough Devices
| Manufacturer | Trade Name | Submission Number | Submission Decision Date |
|---|---|---|---|
| SI-BONE, INC | IFUSE BEDROCK GRANITE IMPLANT SYSTEM | K222774 | 12/22/2022 |
| ROCHE DIAGONOSTICS | ELECSYS B-AMYLOID (1-42) CSF II, | K221842 | 12/7/2022 |
| ELECSYS PHOSPHO-TAU (181P) CSF | |||
| ULTROMICS LIMITED | ECHOGO HEART FAILURE | K222463 | 11/23/2022 |
| CALA HEALTH, INC. | CALA KIQ | K222237 | 11/22/2022 |
| CARLSMED, INC. | APREVO ANTERIOR LUMBAR INTERBODY FUSION DEVICE WITH INTERFIXATION | K222009 | 11/22/2022 |
| ARGENTUM MEDICAL, INC. | SILVERLON WOUND CONTACT, BURN CONTACT DRESSINGS | K221218 | 10/26/2022 |
| PHAGENESIS LIMITED | PHAGENYX SYSTEM | DEN220025 | 9/16/2022 |
| MAGNUS MEDICAL, INC. | MAGNUS NEUROMODULATION SYSTEM (MNS) WITH SAINT TECHNOLOGY, MODEL NUMBER 1001K | K220177 | 9/1/2022 |
| RENOVIA, INC. | LEVA PELVIC HEALTH SYSTEM | K213913 | 6/30/2022 |
| EARLITEC DIAGNOSTICS, INC. | EARLIPOINT SYSTEM | K213882 | 6/8/2022 |
| SI-BONE, INC. | IFUSE BEDROCK GRANITE IMPLANT SYSTEM | K220195 | 5/26/2022 |
| NEUROMETRIX, INC. | QUELL-FM | DEN210046 | 5/18/2022 |
| BONESUPPORT AB | CERAMENT G | DEN210044 | 5/17/2022 |
| W. L. GORE & ASSOCIATES, INC. | GORE TAG THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE) | P210032 | 5/13/2022 |
| FUJIREBIO DIAGNOSTICS, INC. | LUMIPULSE G ß-AMYLOID RATIO (1-42/1-40) | DEN200072 | 5/4/2022 |
| TRANSMEDICS, INC. | ORGAN CARE SYSTEM (OCS) HEART SYSTEM | P180051/S001 | 4/27/2022 |
| ULTRATHERA TECHNOLOGIES, INC. | GYROSTIM | K220231 | 4/27/2022 |
| VASCUTEK, LTD. | THORAFLEX HYBRID | P210006 | 4/19/2022 |
| CARTIHEAL, LTD. | AGILI-C | P210034 | 3/29/2022 |
| SPECTRANETICS, INC. | CAVACLEAR LASER SHEATH | DEN210024 | 12/21/2021 |
| KOIOS MEDICAL, INC. | KOIOS DS | K212616 | 12/16/2021 |
| APPLIEDVR, INC. | EASEVRX | DEN210014 | 11/16/2021 |
| SYNCTHINK, INC. | EYE-SYNC | K202927 | 10/2/2021 |
| PAIGE.AI | PAIGE PROSTATE | DEN200080 | 9/21/2021 |
| CANARY MEDICAL, INC. | CANARY TIBIAL EXTENSION WITH CANARY HEALTH IMPLANTED REPORTING PROCESSOR (CHIRP) SYSTEM | DEN200064 | 8/27/2021 |
| MICROTRANSPONDER, INC. | VIVISTIM PAIRED VNS SYSTEM | P210007 | 8/27/2021 |
| SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ADVIA CENTAUR ENHANCED LIVER FIBROSIS (ELF) | DEN190056 | 8/20/2021 |
| CARLSMED, INC. | APREVO TRANSFORAMINAL IBF | K210542 | 6/30/2021 |
| COGNOA, INC. | COGNOA ASD DIAGNOSIS AID | DEN200069 | 6/2/2021 |
| NEUROLUTIONS, INC. | NEUROLUTIONS IPSIHAND UPPER EXTREMITY REHABILITATION SYSTEM | DEN200046 | 4/23/2021 |
| HELIUS MEDICAL, INC. | PORTABLE NEUROMODULATION STIMULATOR (PONS) | DEN200050 | 3/26/2021 |
| MEDTRONIC, INC. | HARMONY TPV SYSTEM | P200046 | 3/26/2021 |
| SHOCKWAVE MEDICAL, INC. | SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) SYSTEM WITH SHOCKWAVE C2 CORONARY INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER | P200039 | 2/12/2021 |
| ABBOTT LABORATORIES | I-STAT ALINITY SYSTEM | K201778 | 1/8/2021 |
| CARLSMED, INC. | APREVO INTERVERTEBRAL BODY FUSION DEVICE | K202034 | 12/3/2020 |
| CERUS CORPORATION | INTERCEPT BLOOD SYSTEM FOR PLASMA | BP130076/S034 | 11/24/2020 |
| NIGHTWARE, INC. | NIGHTWARE KIT | DEN200033 | 11/6/2020 |
| FOUNDATION MEDICINE, INC. | FOUNDATIONONE LIQUID CDX | P200006 | 10/26/2020 |
| ROCHE MOLECULAR SYSTEMS, INC. | COBAS BKV | K202215 | 9/2/2020 |
| MEDTRONIC MINIMED, INC. | MINIMED 770G SYSTEM | P160017/S076 | 8/31/2020 |
| FOUNDATION MEDICINE, INC. | FOUNDATIONONE LIQUID CDX | P190032 | 8/26/2020 |
| GUARDANT HEALTH, INC. | GUARDANT360 CDx | P200010 | 8/7/2020 |
| ROCHE MOLECULAR SYSTEMS, INC. | COBAS EBV | DEN200015 | 7/30/2020 |
| AMBU INNOVATION GMBH | AMBU DUODENO SYSTEM | K201098 | 7/17/2020 |
| BAY LABS, INC. | CAPTION GUIDANCE | DEN190040 | 2/7/2020 |
| BOSTON SCIENTIFIC | EXALT MODEL D, SINGLE-USE DUODENOSCOPE, EXALT CONTROLLER | K193202 | 12/13/2019 |
| TUSKER MEDICAL | TULA SYSTEM | P190016 | 11/25/2019 |
| ORASURE TECHNOLOGIES | ORAQUICK EBOLA RAPID ANTIGEN TEST | DEN190025 | 10/10/2019 |
| CVRX, INC. | BAROSTIM NEO SYSTEM | P180050 | 8/16/2019 |
| IMPULSE DYNAMICS, INC. | OPTIMIZER SMART SYSTEM | P180036 | 3/21/2019 |
| PEAR THERAPEUTICS | RESET-O | K173681 | 12/10/2018 |
| SPIRATION, INC. | SPIRATION VALVE SYSTEM | P180007 | 12/3/2018 |
| AVITA MEDICAL, LLC. | RECELL AUTOLOGOUS CELL HARVESTING DEVICE | BP170122 | 9/20/2018 |
| PULMONX CORPORATION | ZEPHYR ENDOBRONCHIAL VALVE SYSTEM | P180002 | 6/29/2018 |
| MEDTRONIC MINIMED, INC. | MINIMED 670G SYSTEM | P160017/S031 | 6/21/2018 |
| CLINICAL RESEARCH CONSULTANTS, INC. | CUSTOMFLEX ARTIFICIAL IRIS | P170039 | 5/30/2018 |
| IDX, LLC | IDX-DR | DEN180001 | 4/11/2018 |
| CONCENTRIC MEDICAL, INC. | TREVO PRO VUE RETRIEVER AND TREVO XP PRO VUE RETRIEVER (TREVO RETRIEVER) | K173352 | 2/15/2018 |
| BANYAN BIOMARKERS, INC. | BANYAN BTI | DEN170045 | 2/14/2018 |
| EMPATICA SRL | EMBRACE | K172935 | 1/26/2018 |
| FOUNDATION MEDICINE, INC. | FOUNDATIONONE CDX | P170019 | 11/30/2017 |
| INSIGHTEC | EXABLATE | P150038 | 7/11/2016 |