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Specialty Devices

Myomo gets CE mark for MyoPro myoelectric arm brace Medical robotics firm Myomo has secured CE mark for commercial sale of its MyoPro myoelectric arm orthosis throughout the European Economic Area (EEA). Specialty Devices > Orthopedic Devices > News

Latest Specialty Devices News by Sector

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Anesthesia & Respiratory Devices

FDA approves Adherium’s new inhaler monitoring device
By MDBR Staff Writer
Adherium has received 510(K) clearance from the US Food and Drug Administration (FDA) for its new inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler.
Patient Care > Patient Monitoring > News
Verathon launches new portable handheld video laryngoscope system
Verathon has announced the launch of its all-new GlideScope Go video laryngoscope system.
Specialty Devices > Anesthesia & Respiratory Devices > News

Cardiovascular Devices

Abbott starts US study of Amplatzer device to correct common congenital heart defect in newborns
Abbott has started a US pivotal clinical study evaluating the safety and effectiveness of a modified version of its Amplatzer device designed to correct a common congenital heart defect that occurs in approximately 80,000 pre-term infants in the US each year.
Specialty Devices > Cardiovascular Devices > News
Biotronik's tiny, MRI-safe CRT pacemaker secures FDA approval
By MDBR Staff Writer
Biotronik has secured approval from the US Food and Drug Administration (FDA) for its Edora HF-T QP, a MR conditional quadripolar (QP) cardiac resynchronization therapy pacemaker (CRT-P).
Specialty Devices > Cardiovascular Devices > News

Dental Devices

Young Innovations announces acquisition of VarnishAmerica
Young Innovations, a global manufacturer and distributor of dental supplies and equipment, today announced the acquisition of VarnishAmerica and other product lines from Medical Products Laboratories.
Specialty Devices > Dental Devices > News
Natural Dental Implants develops 3D printed tooth
By MDBR Staff Writer
German firm Natural Dental Implants (NDI) has developed a 3D printed version of the Replicate tooth.
Patient Care > Patient Monitoring > News

Diabetes Care Devices

Dexcom, Fitbit collaborate to develop diabetes management tools
By MDBR Staff Writer
DexCom has collaborated with wearables brand Fitbit to develop and commercialise easy-to-use mobile tools for patients to better manage their diabetes.
Specialty Devices > Diabetes Care Devices > News
EnteroMedics secures approval for Gastric Vest system clinical trial in Spain
EnteroMedics has secured approval from the Ministry of Health, Social Services, and Equality (MHSSE) in Spain via the Agency of Medicines and Medical Devices, and the CEIC Ethics Committee to start a clinical trial for the Gastric Vest System in Spain.
Specialty Devices > Diabetes Care Devices > News

Orthopedic Devices

K2M launches Everest minimally invasive XTower instrumentation
K2M Group Holdings has launched Everest minimally invasive (MI) XTower instrumentation, an enhancement to the Everest MI XT spinal system, at the Society for Minimally Invasive Spine Surgery Annual Forum (SMISS) event.
Specialty Devices > Orthopedic Devices > News
Spinal Resources’ Swedge pedicle screw system gets FDA 510(k) clearance
Spinal Resources (SRI) announced that it has received FDA 510(k) clearance for its Swedge pedicle screw system.
Specialty Devices > Orthopedic Devices > News

Drug Delivery Devices

Medtronic gets Japanese regulatory approval for IN.PACT admiral drug-coated balloon
Medtronic announced that the IN.PACT admiral drug-coated balloon (DCB) received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of peripheral artery disease (PAD) in the upper leg - specifically, in the thigh (superficial femoral arteries (SFA)) and behind the knee (popliteal arteries).
Specialty Devices > Drug Delivery Devices > News
FDA grants OTC clearance for ABMC’s Rapid TOX Cup II
American Bio Medica (ABMC) announced that the US Food and Drug Administration (FDA) has granted 510(k) marketing clearance for over-the-counter use to the company's Rapid TOX Cup II drug test product line.
Specialty Devices > Drug Delivery Devices > News