AnatomyOrganismsDiseasesChemicals and DrugsAnalytical, Diagnostic and Therapeutic Techniques and EquipmentPsychiatry and PsychologyPhenomena and ProcessesDisciplines and OccupationsAnthropology, Education, Sociology and Social PhenomenaTechnology, Industry, AgricultureHumanitiesInformation ScienceNamed GroupsHealth CareGeographicals
Breakthrough PainTerminology as TopicOrphan Drug ProductionRadionuclide GeneratorsPhylogenyMolecular Sequence DataEponymsRare DiseasesChlorofluorocarbonsSequence Analysis, DNADrug ApprovalAdministration, BuccalLamivudineChickenpoxUnited States Food and Drug AdministrationUnited StatesMercury CompoundsRespiratory Protective DevicesRNA, Ribosomal, 16SMetrorrhagiaFungemiaFentanylAmino Acid SequenceEpicardial MappingDNA, BacterialHepatitis B, ChronicAntiviral AgentsBase SequenceLevonorgestrelDNA, RibosomalCheeseBody Surface Potential MappingTreatment OutcomeGastric Acidity DeterminationSpecies SpecificityGenetic VariationMutationPrecipitating FactorsPhenotypeHepatitis B e AntigensTrauma CentersAntifungal AgentsAnalgesics, OpioidTime FactorsBacterial Typing TechniquesHistory, 20th CenturyCharcoalMedically Underserved AreaDrug Resistance, ViralNeoplasmsGenotypeContraceptive Agents, FemaleRetrospective StudiesLabor PainTherapeuticsHistory, 21st CenturyOrganophosphonatesGastric AcidIntrauterine Devices, Medicated2-PyridinylmethylsulfinylbenzimidazolesZygomycosisEchinocandinsSlovakiaPolymerase Chain ReactionProduct LabelingSerotypingHepatitis B virusHeart Conduction SystemHistory, 19th CenturyGloves, ProtectiveBabesia bovisUterine HemorrhageHistory, 17th CenturyOmeprazoleTrichosporonosisCluster AnalysisGenes, BacterialChemopreventionMycosesBacterial ProteinsAdenineIridiumCarboxinCandidiasisVesico-Ureteral RefluxNobel PrizeHistory, 16th CenturyClostridium tertiumPainDrug Therapy, CombinationAnti-Ulcer AgentsTreatment FailureReverse Transcriptase InhibitorsGenes, rRNAHospitalsRNA, Ribosomal, 23SDrug SubstitutionPericardiumTrichosporonGastroesophageal Reflux
TherapyNUsurface Meniscus ImplantCyberSecurity Breakthrough AwardsUnmet needExpediteReceived breakthrough deviceIndications2022Meniscus2023RecognitionVaccineTreatmentProgramChief medicalAccelerateClinicalOrganization that recognizesReflectsReceive priorityFood and Drug AdminRegulatoryPatientsPotentialWorthyReviewDataSystemMedicalCriteriaTechnologySignificantPublicationCompanyPress releaseProvideFast Track
Therapy53
  • Drugs granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA). (wikipedia.org)
  • Drugs may be listed more than once since breakthrough therapy can be awarded for multiple indications. (wikipedia.org)
  • CDER Breakthrough Therapy Designation Approvals Data as of December 31, 2022" (PDF). (wikipedia.org)
  • AstraZeneca and MSD have announced the granting of Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for its MEK 1/2 inhibitor and potential new medicine selumetinib. (pharmatimes.com)
  • The Breakthrough Therapy Designation acknowledges the significant unmet need of these patients and the potential benefit of selumetinib in this setting. (pharmatimes.com)
  • The FDA has granted Breakthrough Therapy Designation for an investigational antibody drug for the treatment of primary progressive multiple sclerosis (PPMS). (pharmacytimes.com)
  • Ocrelizumab is the first investigational medicine for MS to be granted Breakthrough Therapy Designation by the FDA," said head of Global Product Development, Sandra Horning, MD. "With no approved treatments for primary progressive MS, ocrelizumab has the potential to address an important unmet need. (pharmacytimes.com)
  • The designation is for the Prapela SVS hospital bassinet pad used as adjunctive therapy in newborns with prenatal opioid exposure and/or diagnosed with neonatal abstinence syndrome. (masslifesciences.com)
  • A drug which could become the first ever treatment for Autism Spectrum Disorder has been granted Breakthrough Therapy Designation by the FDA. (pharmaphorum.com)
  • The FDA assigns breakthrough therapy designation to expedite the development and review of drugs and vaccines that are intended to prevent or treat serious conditions. (pharmacytimes.com)
  • The combination of tiragolumab and atezolizumab (Tecentriq) was granted breakthrough therapy designation based on promising efficacy and safety data observed in the phase 2 CITYSCAPE trial. (cancernetwork.com)
  • The FDA has granted the novel cancer immunotherapy tiragolumab breakthrough therapy designation (BTD) in combination with atezolizumab (Tecentriq) for the first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations, according to Roche, the developer of the agent. (cancernetwork.com)
  • 1. Roche's novel anti-TIGIT tiragolumab granted FDA Breakthrough Therapy Designation in combination with Tecentriq for PD-L1-high non-small cell lung cancer. (cancernetwork.com)
  • Merck & Co's V114 received breakthrough therapy designation by the US Food and Drug Administration. (pharmaceutical-technology.com)
  • On 30 January, Merck & Co's V114 (15-valent pneumococcal conjugate vaccine) received breakthrough therapy designation by the US Food and Drug Administration (FDA), for the prevention of invasive pneumococcal disease in infants, children and adolescents. (pharmaceutical-technology.com)
  • However, Pfizer also has a late-stage, 20-valent conjugate pneumococcal vaccine, 20vPnC, which has also received FDA breakthrough therapy designation in adults. (pharmaceutical-technology.com)
  • This, in addition to V114's breakthrough therapy designation for infants, means that Pfizer' Prevnar 13 could stand to lose its grip on the lucrative pneumococcal vaccine market in infants. (pharmaceutical-technology.com)
  • RARITAN, NJ - April 8, 2013 - Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted a third Breakthrough Therapy Designation for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib. (jnj.com)
  • Ibrutinib has been granted Breakthrough Therapy Designation as a monotherapy in the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with deletion of the short arm of chromosome 17 (del17p). (jnj.com)
  • This third Breakthrough Therapy Designation reflects the potential importance of ibrutinib for patients diagnosed with a 17p deletion chromosomal abnormality in CLL/SLL, and we are committed to working with Pharmacyclics and the FDA to expedite development and review of ibrutinib as quickly as possible. (jnj.com)
  • The implications of Breakthrough Therapy Designation cannot be determined at this time. (jnj.com)
  • Janssen and Pharmacyclics are working with the FDA to determine any potential implications of the Breakthrough Therapy Designation to the ongoing and planned development activities. (jnj.com)
  • In February 2013 , FDA granted Breakthrough Therapy Designations for ibrutinib as a monotherapy for two B-cell malignancies: in patients with relapsed or refractory Mantle cell lymphoma (MCL) who have received prior therapy, and in patients with Waldenström's macroglobulinemia (WM). (jnj.com)
  • Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy Designation is intended to expedite the development and review time for a potential new medicine "to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. (jnj.com)
  • PALO ALTO, Calif., May 26, 2021 /PRNewswire/ -- Varian, a Siemens Healthineers company, announced today that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its cardiac radioablation (CRA) system, currently in development as a noninvasive therapy for select patients with refractory ventricular tachycardia (VT). (varian.com)
  • AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV. (worldpharmanews.com)
  • The Breakthrough Therapy Designation, together with its recent PRIME eligibility from the European Medicines Agency, will help us to bring MEDI8897 to all infants at risk for RSV as quickly as possible. (worldpharmanews.com)
  • TITUSVILLE, N.J., Aug. 16, 2016 - Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for esketamine, an investigational antidepressant medication, for the indication of major depressive disorder with imminent risk for suicide. (jnj.com)
  • This also marks the second time esketamine has received a Breakthrough Therapy Designation from the U.S. regulatory authority. (jnj.com)
  • Breakthrough Therapy Designation is intended to expedite development and review timelines when preliminary clinical evidence indicates the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies for serious or life-threatening conditions. (jnj.com)
  • The esketamine Phase 2 clinical trial data presented by Janssen in May 2016 at the Society of Biological Psychiatry 71st Annual Scientific Meeting in Atlanta, Georgia, provided preliminary clinical evidence to support the Breakthrough Therapy Designation for major depressive disorder with imminent risk for suicide. (jnj.com)
  • The U.S. Food and Drug Administration (FDA) granted lenvatinib (Lenvima) Breakthrough Therapy designation for investigational use in patients with advanced or metastatic renal cell carcinoma who were previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy. (ascopost.com)
  • Lenvatinib was designated as a Breakthrough Therapy based on results of a phase II open-label, multicenter study involving 153 patients who were previously treated with a VEGF-targeted therapy and randomly assigned 1:1:1 to receive lenvatinib and everolimus (Afinitor), lenvatinib, or everolimus. (ascopost.com)
  • The FDA granted Breakthrough Therapy Designation to BAVENCIO for this indication, and the sBLA is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. (emdserono.com)
  • The United States Food and Drug Administration has granted Galderma's nemolizumab a Breakthrough Therapy Designation following phase 2 results which suggests the drug is a considerable alleviant for pruritus associated with prurigo nodularis. (dermatologytimes.com)
  • The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to AbbVie's investigational hepatitis C virus (HCV) regimen. (hepmag.com)
  • The FDA has granted olaparib (Lynparza), a first-in-class oral PARP inhibitor, breakthrough therapy designation for patients with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer (mCRPC). (targetedonc.com)
  • The Breakthrough Therapy designation for Lynparza is encouraging news for patients, and their families, as there are currently very limited treatment options for metastatic castration-resistant prostate cancer. (targetedonc.com)
  • Under the breakthrough therapy designation, the FDA will expedite review of submission data within 60 days of receiving it. (targetedonc.com)
  • AstraZeneca has been granted the FDA breakthrough therapy designation for durvalumab, an immunotherapy treatment PD-L1-positive inoperable or metastatic urothelial bladder cancer following progression on prior treatment with a platinum-based regimen. (patientsrising.org)
  • and SAN DIEGO, April 08, 2019 (GLOBE NEWSWIRE) - PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for orphan diseases, today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy designation for PB2452, a novel reversal agent for the antiplatelet drug ticagrelor. (mtngp.com)
  • Breakthrough Therapy designation is designed to expedite the development and review of promising new drugs for serious or life-threatening conditions, when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. (mtngp.com)
  • With all the features of the Fast Track program, Breakthrough Therapy designation also offers companies the opportunity for increased communication with FDA and an organizational commitment involving more intensive guidance from FDA senior managers. (mtngp.com)
  • The Breakthrough Therapy designation for PB2452 was supported by Phase 1 trial results, in which PB2452 achieved immediate and sustained reversal of ticagrelor's antiplatelet effects. (mtngp.com)
  • Breakthrough Therapy designation for PB2452 highlights the critical unmet need for a therapy to reverse the antiplatelet activity of ticagrelor, which is widely prescribed to patients with acute coronary syndrome or a history of heart attack," said John Lee, M.D., Chief Medical Officer of PhaseBio. (mtngp.com)
  • Breakthrough Therapy designation supports our goal of making the first approved reversal agent for ticagrelor available to patients and physicians as soon as possible. (mtngp.com)
  • GlaxoSmithKline plc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Tafinlar® (dabrafenib) for treatment of patients with metastatic BRAF V600E mutation-positive non-small cell lung cancer (NSCLC) who have received at least one prior line of platinum-containing chemotherapy. (worldpharmatoday.com)
  • The Breakthrough Therapy designation was based on interim efficacy and safety results from an ongoing Phase II study of dabrafenib administered orally to 25 patients who had NSCLC with the BRAF V600E mutation and who had received at least one previous course of chemotherapy. (worldpharmatoday.com)
  • The Breakthrough Therapy designation was enacted as part of the 2012 FDA Safety and Innovation Act and is intended to expedite development and review of drugs to treat serious or life-threatening medical conditions when preliminary clinical evidence demonstrates that the drug may have substantial improvement on at least one clinically significant endpoint over available therapies. (worldpharmatoday.com)
  • Breakthrough Therapy designation includes all the features of the Fast Track designation, as well as more intensive guidance from the FDA on a drug's clinical development program. (worldpharmatoday.com)
  • SHANGHAI, Feb. 27, 2015 - WuXi PharmaTech (Cayman) Inc. (NYSE: WX), a leading open-access R&D capability and technology platform company serving the pharmaceutical, biotechnology, and medical device industries with operations in China and the United States, congratulates our partner TaiMed Biologics for receiving breakthrough therapy designation from the U.S. FDA for ibalizumab (TMB355). (wuxibiologics.com)
  • The FDA designates a drug as a breakthrough therapy if it is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. (wuxibiologics.com)
  • The US Food and Drug Administration (FDA) granted NBI-98854 Breakthrough Therapy Designation for the treatment of tardive dyskinesia in October 2014. (medscape.com)
NUsurface Meniscus Implant3
  • FDA has granted a Breakthrough Device Designation to Active Implants' NUsurface ® Meniscus Implant. (medicaldesignbriefs.com)
  • Creating a new segment in meniscal surgery with meniscus replacement, their Nusurface Meniscus Implant has been granted breakthrough device designation by the FDA. (idataresearch.com)
  • Joint preservation developer Active Implants has been granted Breakthrough Device Designation from the Food and Drug Administration for its NUsurface Meniscus Implant. (med-technews.com)
CyberSecurity Breakthrough Awards6
  • SEATTLE--( BUSINESS WIRE )--AuthenticID, a global leader in identity proofing and fraud prevention solutions, has been selected by CyberSecurity Breakthrough as a winner of the "Authentication Solution of the Year" award in the 7th annual CyberSecurity Breakthrough Awards program. (businesswire.com)
  • The mission of the CyberSecurity Breakthrough Awards is to honor excellence and recognize the innovation, hard work, and success in a range of information security categories, including Cloud Security, Threat Detection, Risk Management, Fraud Prevention, Mobile Security, Email Security, and many more. (businesswire.com)
  • Part of Tech Breakthrough , a leading market intelligence and recognition platform for global technology innovation and leadership, the CyberSecurity Breakthrough Awards program is devoted to honoring excellence in information security and cybersecurity technology companies, products and people. (businesswire.com)
  • The CyberSecurity Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough information security companies and products in categories including Cloud Security, Threat Detection, Risk Management, Fraud Prevention, Mobile Security, Web and Email Security, UTM, Firewall and more. (businesswire.com)
  • NEW YORK, NY - December 12, 2017 - Align , the premier global provider of technology infrastructure solutions and cybersecurity services, announced today that it was selected as the winner of the "Overall Risk Management Solution Provider of the Year" award in the 2017 CyberSecurity Breakthrough Awards. (align.com)
  • The CyberSecurity Breakthrough Awards program is devoted to honoring excellence in information security and cybersecurity technology companies, products and people. (align.com)
Unmet need2
  • The Breakthrough Device Designation is a significant step in our mission to fulfill a substantial unmet need in the U.S. orthopedic market," says Ted Davis, president and CEO of Active Implants. (medicaldesignbriefs.com)
  • The FDA's designation of the BlueLeaf endovenous valve formation system as Breakthrough is an important recognition of both the tremendous unmet need for deep vein reflux patients and the potential of the novel non-implant valve technology as treatment for the severe symptoms they frequently experience. (venousnews.com)
Expedite4
  • Click Therapeutics chief strategy officer Austin Speier said: "We are thrilled to receive this Breakthrough designation as it will facilitate collaborative discussions with the FDA and help expedite the process of bringing a first-in-class migraine digital therapeutic to patients. (medicaldevice-network.com)
  • The breakthrough designation is intended to expedite the development of glecaprevir/pibrentasvir as well as its FDA review process. (hepmag.com)
  • The FDA Breakthrough Devices Program was implemented to expedite the development and review process for medical devices that are novel or offer new technology for patients with life-threatening or irreversibly debilitating conditions. (med-technews.com)
  • The Breakthrough device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system," Powell added. (takethehealth.com)
Received breakthrough device5
  • Prapela, Inc. announces it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). (masslifesciences.com)
  • We are thrilled to have received breakthrough device designation and pleased to have the strong, continued support from our investors. (wreg.com)
  • We are thrilled to have received breakthrough device designation and pleased to have the strong, continued support from our investors, both significant milestones for the company," commented Dr. Nitin Salunke , President and CEO of Supira Medical. (wreg.com)
  • PAVmed Inc. , a differentiated, multiproduct medical device company, announced that the company's majority owned subsidiary, Lucid Diagnostics Inc. has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its EsoGuard Esophageal DNA Test on esophageal samples collected using its EsoCheck Cell Collection Device in a prevalent well-defined group of patients at elevated risk for esophageal dysplasia due to chronic gastroesophageal reflux disease (GERD). (mpo-mag.com)
  • InterVene recently announced that it has received Breakthrough Device designation from the US Food and Drug Administration (FDA) for the company's BlueLeaf endovenous valve formation system. (venousnews.com)
Indications1
  • I am very gratified that FDA agreed with us that EsoGuard satisfies all of its criteria for Breakthrough Device designation for the proposed indications for use," said Alberto Gutierrez, Ph.D., Lucid's regulatory consultant and former director of the FDA's Office of In-Vitro Diagnostics (OIVD). (mpo-mag.com)
20221
  • In April 2022, GBS6 was also granted PRIME designation by the European Medicines Agency's Committee for Medicinal Products for Human Use, which supports the development of medications that target an unmet medical need. (pharmacytimes.com)
Meniscus1
20231
  • LOS GATOS, Calif. , Nov. 21, 2023 /PRNewswire/ -- Supira Medical, Inc. , a Shifamed portfolio company, announced today that it has received U.S. Food and Drug Administration (FDA) breakthrough device designation for its Supira System, a next-generation percutaneous ventricular assist device (pVAD). (wreg.com)
Recognition1
  • Tech Breakthrough LLC does not endorse any vendor, product or service depicted in our recognition programs, and does not advise technology users to select only those vendors with award designations. (businesswire.com)
Vaccine1
  • Based on 30 SARS-CoV-2 RT-PCR-positive specimens from inpa- available data, seven (2%) vaccine breakthrough cases§§ were tients and outpatients to CDPHE for sequencing each week. (cdc.gov)
Treatment14
  • The FDA Breakthrough Devices Program recognizes medical devices that meet certain criteria and hold the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. (biospace.com)
  • Selumetinib was already granted Orphan Drug Designation for the treatment of NF1 by the US FDA in February 2018, and the European Medicines Agency in August 2018. (pharmatimes.com)
  • Varian's CRA system was designated a Breakthrough Device by the FDA because of its potential to offer a more effective treatment for select patients with refractory VT. (varian.com)
  • The FDA Breakthrough Device Program is intended to provide patients with more timely access to medical devices that have the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. (varian.com)
  • The FDA Breakthrough Device Program was created to offer patients more timely access to breakthrough technologies which "provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions" by expediting their development, assessment and review through enhanced communications and more efficient and flexible clinical study design, including more favorable pre/post market data collection balance. (mpo-mag.com)
  • Esketamine was first granted this designation for treatment-resistant depression in November 2013. (jnj.com)
  • This designation reinforces the potential of esketamine as a novel treatment for patients with major depressive disorder who are at imminent risk for suicide, a condition for which there currently is no approved treatment and which represents a major public health challenge. (jnj.com)
  • To qualify for FDA "breakthrough device" designation under the 21st Century Cures Act (Cures Act), makers of new medical devices must demonstrate that the product provides for "more effective treatment or diagnosis" of a life-threatening or irreversibly debilitating human disease or condition. (g2intelligence.com)
  • These two new breakthrough device designations will help us accelerate our mission to bring life-saving diagnosis and treatment to cancer patients as early as possible. (targetedonc.com)
  • The designation was given based on results from the Phase II MAGELLAN-1 study of glecaprevir/pibrentasvir among people with genotype 1 of the virus who failed a previous treatment attempt. (hepmag.com)
  • Unity HA announces today that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to the Pulsante® SPG Microstimulator System for the treatment of acute headache pain associated with chronic cluster headaches. (realeve.net)
  • Recently the results of a double blind, randomized controlled clinical trial has been published in The Lancet journal 1 , and this breakthrough designation brings us closer to a potential long term treatment option for patients with cluster headaches. (realeve.net)
  • Breakthrough Device designation is only awarded to breakthrough technologies that have the potential to provide more effective treatment and diagnosis for life-threatening or irreversible debilitating diseases or conditions. (ceramtec-medical.com)
  • The breakthrough devices programme is a voluntary programme for certain medical devices and certain device-led products, that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, with the aim to provide timely access to these devices and lower the burden required for Medicare reimbursement. (neuronewsinternational.com)
Program5
  • I have participated in the designation of several IVD Breakthrough Devices and understand the value this brings to Lucid's clinical development program. (mpo-mag.com)
  • PDUFA VII Already: Could Breakthrough Ideas Apply Outside Program? (citeline.com)
  • The Breakthrough Devices Program was established by the FDA to provide patients and healthcare providers with timely access to transformative medical devices through frequent interactions with the manufacturer during in development, assessment, and review of innovative medical devices. (realeve.net)
  • The goal of the FDA's Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review. (ceramtec-medical.com)
  • Through the Breakthrough Device program, the FDA will provide ProLung with expedited reviews and the Centers for Medicare Medicaid Services (CMS) has provisions for a simpler and faster pathway to reimbursement. (ioniqsciences.com)
Chief medical1
  • Click Therapeutics chief medical officer Shaheen Lakhan said: "Breakthrough further affirms that our unique approach to unlock undruggable CNS targets has merit through the combination of digital neuroactivation and modulation (DiNaMo) and neurobehavioral interventions. (medicaldevice-network.com)
Accelerate1
  • We're excited about the Breakthrough Device designation and the potential to accelerate our BioPoly Knee System into the US market. (biopolyortho.com)
Clinical4
  • Currently, the test is available for both research and clinical use and has been granted a total of 3 breakthrough device designations by the FDA for multiple cancer types. (targetedonc.com)
  • Data and Evidence -The sponsor seeking the designation must provide sufficient data and evidence to support the potential clinical benefit of the device. (victech.com)
  • Flexible Clinical Trial Design -The FDA may provide flexibility in the design of clinical trials for breakthrough devices. (victech.com)
  • I am thrilled that the BioPoly Knee System has been recognized by the FDA as a Breakthrough Device, and we now have the ability to move quickly through the regulatory process with our FDA-approved clinical study," says Herb Schwartz, Founder and CTO of BioPoly. (biopolyortho.com)
Organization that recognizes1
  • CyberSecurity Breakthrough is a leading independent market intelligence organization that recognizes the global information security market's top companies, technologies, and products. (businesswire.com)
Reflects1
  • Our designation as a Breakthrough Device reflects the significance of our potential future contribution in the leading cause of cancer mortality in the U.S. (biospace.com)
Receive priority2
  • Breakthrough Devices receive priority FDA review, and a bipartisan bill before Congress (H.R. 5333) seeks to require Medicare to temporarily cover all Breakthrough Devices for three years while determining permanent coverage. (mpo-mag.com)
  • Expedited Review Process -Devices designated as breakthrough receive priority review, which means the FDA commits to providing timely feedback to the manufacturer during the development process. (victech.com)
Food and Drug Admin7
  • HAYWARD, Calif.--( BUSINESS WIRE )-- RefleXion Medical, Inc ., a therapeutic oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for its biology-guided radiotherapy* ( BgRT ) for use in treating lung tumors. (biospace.com)
  • FloBio , a medical diagnostics company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. (clpmag.com)
  • Click Therapeutics has secured Breakthrough Device Designation for its CT-132 prescription digital therapeutic to treat episodic migraine, from the US Food and Drug Administration (FDA). (medicaldevice-network.com)
  • Chinese medical device company Pulse Medical Technology has received the US Food and Drug Administration (FDA) Breakthrough Device designation for its fourth generation μFR system. (nsmedicaldevices.com)
  • Roche announced on Tuesday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Elecsys Amyloid Plasma Panel for the detection of Alzheimer's disease. (labpulse.com)
  • The US Food and Drug Administration (FDA) has granted breakthrough device designation to the Avantis spinal cord stimulation system (Reach Neuro, Inc), which has been shown in early testing to restore arm and hand movement in patients with post-stroke upper limb paresis. (takethehealth.com)
  • The US Food and Drug Administration (FDA) has granted breakthrough device designation to the Stentrode brain-computer interface for its fully-implantable medical device that can translate brain activity or stimulate the nervous system from the inside of a blood vessel, without the need for open brain surgery. (neuronewsinternational.com)
Regulatory2
  • More Frequent Interactions -Manufacturers of breakthrough devices are given increased access to FDA staff for development and regulatory requirements discussions. (victech.com)
  • The designation as a Breakthrough Device by the regulatory authority is an encouraging signal to CeramTec. (ceramtec-medical.com)
Patients5
  • The designation followed positive results from a phase 3 double-blind global multi-center study that showed a significant reduction in disability progression and other markers of disease activity in patients administered Ocrevus compared with placebo. (pharmacytimes.com)
  • FDA's Breakthrough Products: Could Patients Drive The Designations? (citeline.com)
  • Sen. Bennet is receiving letters from patients asking to talk with FDA about products they think could be a breakthrough. (citeline.com)
  • The designation is meant to help patients gain faster access to innovative medical technologies that have the potential to offer significant improvements over existing options. (victech.com)
  • Early Access to Patients -Breakthrough devices might be made available to patients sooner, especially if they address unmet medical needs or offer substantial benefits over existing treatments. (victech.com)
Potential3
  • The breakthrough potential of BgRT lies in its ability to detect and then immediately treat moving tumors. (biospace.com)
  • This designation validates our belief that EsoGuard is a groundbreaking technology that has the potential to have as great an impact on esophageal cancer as widespread Pap screening has had in preventing deaths from cervical cancer. (mpo-mag.com)
  • Potential for Earlier Reimbursement -An FDA Breakthrough Device designation can signal to payers and reimbursement agencies that the device is considered innovative and potentially valuable. (victech.com)
Worthy2
  • I am very excited that the FDA deemed EsoGuard worthy of Breakthrough Device designation. (mpo-mag.com)
  • Solutions to deep vein reflux have been elusive despite decades of research, and InterVene's autologous, endovenous approach is worthy of prioritisation, so the designation is a fitting and positive development," said William Marston, the George Johnson Jr distinguished professor of Vascular Surgery at the University of North Carolina School of Medicine (Chapel Hill, USA). (venousnews.com)
Review2
  • The designation, which accelerates the development and review of, is based on data from the phase II TOPARP-A trial. (targetedonc.com)
  • Dedicated Review Team -Breakthrough devices are assigned a dedicated FDA review team, which can lead to a more streamlined and coordinated review process, reducing delays. (victech.com)
Data3
  • The first anti-TIGIT molecule to be granted this designation, tiragolumab was granted BTD based on data from the global, double-blind, randomized phase 2 CITYSCAPE trial (NCT03563716). (cancernetwork.com)
  • Critics say many of these drugs are not actually 'breakthrough' medicines because they are based on preliminary data. (patientsrising.org)
  • Newly developed miniature data acquisition systems (MIDAS) were used to measure bolt load changes during initial face advance and cross-cut breakthrough. (cdc.gov)
System2
  • As a heart rhythm specialist who routinely treats individuals with VT, I am thrilled to see the FDA recognize Varian's cardiac radioablation system as a breakthrough technology. (varian.com)
  • FORT WAYNE, IN - BioPoly LLC announced today the FDA has granted the company a Breakthrough Device designation for its BioPoly Knee System. (biopolyortho.com)
Medical4
  • Garwood Medical Devices was granted a Breakthrough Device designation from FDA for the BioPrax™ device, a minimally invasive electrical stimulation tool in development to help eliminate biofilm infections on knee implants during early intervention procedures. (orthoworld.com)
  • Pulse Medical president Bing LIU said: "We are delighted that μFR has been designated an FDA breakthrough device. (nsmedicaldevices.com)
  • Within the VIC Tech portfolio, SFC Fluidics and Solenic Medical have both announced FDA Breakthrough Device designation. (victech.com)
  • For startup companies developing innovative new medical devices, Breakthrough Device designation adds to the company's overall credibility with investors and has numerous practical benefits. (victech.com)
Criteria1
  • In 2018, the agency issued detailed guidance explaining how it applies the criteria in considering whether to grant breakthrough device clearance. (g2intelligence.com)
Technology1
  • AuthenticID's breakthrough solution guards against algorithmic bias and runs 100% on machine learning and computer vision technology, with patented AI technology that verifies identities with confidence, allowing customers to manage identity-based transactions and solving business challenges around fraud detection and deterrence, onboarding, and staying compliant. (businesswire.com)
Significant1
  • The designation is granted to treatments that may offer a significant advancement over those currently available. (hepmag.com)
Publication1
  • The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. (who.int)
Company1
  • Speaking on the new testing method, Alon Singer, Chief Executive Officer at HelixBind said that the company is thrilled to secure the breakthrough device designation from US FDA and it is a strong validation of the company's work. (itresearchbrief.com)
Press release1
  • To read a press release about the designation, click here . (hepmag.com)
Provide1
  • But what is FDA Breakthrough Device designation and what benefits does it provide? (victech.com)
Fast Track1
  • MEDI8897 is being developed in partnership with Sanofi Pasteur and received Fast Track designation from the US FDA in March 2015. (worldpharmanews.com)