New Approvals – Page 26 – media

Biotronik’s tiny, MRI-safe CRT pacemaker secures FDA approval

Biotronik has secured approval from the US Food and Drug Admini(FDA) for its Edora HF-T QP, a MR conditional quadripolar (QP) cardiac resynchronization therapy pacemaker (CRT-P).
- Source: medicaldevices
- 549
- August 23, 2017
cardiac Company Insight New Approvals QP
FDA approves Malin’s Hourglass peripheral embolization plug

FDA has cleared Irish life sciences company Malin Corp for its Hourglass peripheral embolization plug.
- Source: massdevice
- 566
- August 23, 2017
Company Insight embolization FDA New Approvals peripheral
US regulators wave through Pfizer’s leukaemia drug

Pfizer’s Besponsa has been approved by the US Food and Drug Administration (FDA). It's the first and only CD22-directed antibody-drug conjugate indicated to treat relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
- Source: pharmatimes
- 1,064
- August 21, 2017
ALL antibody Company Insight FDA New Approvals
Camber spine wins FDA nod for Spira interbody fusion device

Camber Spine Technologies' Spira open matrix anterior lumbar interbody fusion device won FDA clearance from the FDA.
- Source: massdevice
- 466
- August 17, 2017
interbody lumbar New Approvals
FDA approves Renovis Surgical’s 3D-printed posterior lumbar interbody fusion systems

The clearance for 3D-printed Tesera porous titanium interbody fusion systems has been secured from the US Food and Drug Administration (FDA) by Renovis Surgical Technologies.
- Source: orthopedicdevices
- 435
- August 15, 2017
Company Insight FDA interbody lumbar New Approvals
FDA clears AUM’s diagnostic cardiovascular device

The US Food and Drug Administration (FDA) has cleared AUM Cardiovascular’s acoustic and electrocardiogram (ECG) device called CADence to aid detection of physiological and pathological heart murmurs.
- Source: medicaldevice-network
- 465
- August 11, 2017
CADence cardiovascular FDA heart New Approvals
NICE backs new treatment option for psoriasis

The National Institute for Health and Care Excellence has issued draft guidelines backing NHS use of Almirall’s Skilarence to treat moderate to severe plaque psoriasis.
- Source: pharmatimes
- 530
- August 9, 2017
Company Insight New Approvals NHS NICE psoriasis
In2Bones wins FDA nod for 2 foot repair systems

In2Bones said today that its US subsidiary received FDA clearance for its 5MS Fracture repair and CoLag locking compression screw systems.
- Source: massdevice.com
- 646
- August 9, 2017
Company Insight deformities fracture New Approvals system
New hepatitis C therapies approved in Europe

Patients with hepatitis C in Europe could soon gain access to two new pan-genotypic treatment options after the European Commission issued approval for AbbVie’s Maviret and Gilead’s Vosevi following an accelerated review.
- Source: pharmatimes
- 449
- August 1, 2017
hepatitis inhibitor New Approvals
EU approves CV benefit claim for Novo’s Victoza

Novo Nordisk’s diabetes drug Victoza is now approved in Europe as the only GLP-1 analogue with a label including prevention of cardiovascular events.
- Source: pharmatimes
- 442
- July 31, 2017
cardiovascular Company Insight diabetes New Approvals

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