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Specialty Devices

FDA approves first electronic device for opioid withdrawal therapy The US Food and Drug Administration (FDA) has granted permission to Innovative Health Solutions to market bridge neurostimulation system NSS-2 Bridge, the first device for use in helping to reduce the symptoms of opioid withdrawal. Specialty Devices > Anesthesia & Respiratory Devices > News

Latest Specialty Devices News by Sector

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Anesthesia & Respiratory Devices

Sunovion gets FDA approval for Lonhala Magnair inhalation solution to treat COPD
Sunovion Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Lonhala Magnair (glycopyrrolate) inhalation solution (25 mcg twice daily), also known as SUN-101/eFlow, for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Specialty Devices > Anesthesia & Respiratory Devices > News
FDA approves first electronic device for opioid withdrawal therapy
The US Food and Drug Administration (FDA) has granted permission to Innovative Health Solutions to market bridge neurostimulation system NSS-2 Bridge, the first device for use in helping to reduce the symptoms of opioid withdrawal.
Specialty Devices > Anesthesia & Respiratory Devices > News

Cardiovascular Devices

PQ Bypass receives IDE approval to initiate study of procedure for patients with peripheral artery disease
PQ Bypass has received conditional approval of its investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate the pivotal DETOUR II clinical trial.
Specialty Devices > Cardiovascular Devices > News
Edwards buys medical technology firm Harpoon Medical
By MDBR Staff Writer
Edwards Lifesciences has acquired medical technology firm Harpoon Medical for $100m.
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

Glooko’s mobile insulin dosing system enhances glycemic control in Type 2 Diabetes
By MDBR Staff Writer
A feasibility study has demonstrated that Glooko’s mobile health app improved glycemic control in people with Type 2 Diabetes
Specialty Devices > Diabetes Care Devices > News
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

Orthopedic Devices

THINK Surgical receives CE mark for the TSolution One surgical system for total knee arthroplasty
THINK Surgical has received CE Mark approval for the TSolution One surgical system, bringing active robotic precision to Total Knee Arthroplasty (TKA).
Specialty Devices > Orthopedic Devices > News
Camber Spine secures FDA clearance for Spira-C open matrix cervical interbody
Camber Spine has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its SPIRA-C Open Matrix Cervical Interbody device, an interbody fusion implant and second in the SPIRA family to employ a novel arched design as well as Surface by Design technology.
Specialty Devices > Orthopedic Devices > News

Drug Delivery Devices

Bayer’s Amikacin Inhale fails to meet primary end point in phase III clinical study
By MDBR Staff Writer
Bayer’s Amikacin Inhale has failed to meet the primary end point in a global phase III clinical study program.
Specialty Devices > Drug Delivery Devices > News
Amgen introduces Enbrel Mini single-dose cartridges with reusable auto-injector
By MDBR Staff Writer
Amgen has announced the US launch of Enbrel Mini single-dose prefilled cartridge with AutoTouch reusable autoinjector tp provide additional administration option for Enbrel (Etanercept) users.
Specialty Devices > Drug Delivery Devices > News