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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

Somnarus' disposable diagnostic patch detects sleep apnea
By MDBR Staff Writer
A clinical trial has demonstrated that Somnarus' new, disposable diagnostic patch effectively identifies obstructive sleep apnea across all severity levels.
Patient Care > Patient Monitoring > News
Philips to acquire US firm RespirTech
By MDBR Staff Writer
Royal Philips has signed an agreement to acquire Respiratory Technologies (RespirTech), a US-based provider of an innovative airway clearance solution for patients with chronic respiratory conditions such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis.
Specialty Devices > Anesthesia & Respiratory Devices > News

Cardiovascular Devices

Medtronic gets CE mark for Attain Stability Quad MRI SureScan active-fixation heart lead
Medtronic announced that it has received CE mark for the Attain Stability Quad MRI SureScan left heart lead.
Specialty Devices > Cardiovascular Devices > News
BioVentrix recruits first patient in IDE study of Revivent TC transcatheter ventricular enhancement system
BioVentrix has announced enrollment of the first patient in the international arm of the ALIVE pivotal clinical trial.
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

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
Insulia receives FDA clearance and CE mark to integrate Toujeo
Voluntis has announced that Insulia, its digital companion for people with Type 2 diabetes, has received FDA clearance and the CE mark to integrate Toujeo (insulin glargine U-300).
Specialty Devices > Diabetes Care Devices > News

Orthopedic Devices

FDA approves Stryker’s Serrato pedicle screw for use in non-cervical spine
By MDBR Staff Writer
Stryker has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Serrato pedicle screw for use in the non-cervical spine, which is part of the firm’s Xia 3 spinal system.
Specialty Devices > Orthopedic Devices > News
FDA approves Renovis Surgical’s 3D-printed posterior lumbar interbody fusion systems
By MDBR Staff Writer
Renovis Surgical Technologies has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its 3D-printed Tesera porous titanium interbody fusion systems.
Specialty Devices > Orthopedic Devices > News

Drug Delivery Devices

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
Surmodics secures IDE approval to start trial of SurVeil drug-coated balloon
Surmodics has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial of the SurVeil™ drug-coated balloon (DCB).
Specialty Devices > Drug Delivery Devices > News