New Approvals – Page 9 – media

Handheld device from Israeli startup to let pregnant women take smartphone ultrasound scans

A technology that can change the way women check their baby’s health is in the final stages of development. PulseNmore LTD, an Israeli startup is developing a handheld ultrasound device that can be connected to any smartphone for monitoring the growth of a fetus.
- Source: drugdu
- 717
- May 11, 2018
digital health New Approvals pregnancy
Lynparza tablets (ovarian cancer) given go-ahead by European regulators

With a view to widening the scope of treatment for ovarian cancer patients, EU regulators have greenlighted MSD’s Lynparza and stamped approval for a new dosing regimen and tablet formulation for AstraZeneca.
- Source: drugdu
- 759
- May 10, 2018
AstraZeneca cancer New Approvals pharma
FDA approve iSchemaView’s 3D CTA

iSchemaView has received FDA approval for its latest product, RAPID CTA, a 3D imaging platform for computed tomography angiography (CTA).
- Source: drugdu
- 3,560
- May 4, 2018
digital health FDA imaging New Approvals
Central Government plan to set up 20 AIIMS, upgrade 73 medical colleges across India

Indian Prime Minister Narendra Modi on Wednesday approved a plan to set up 20 All India Institutes of Medical Sciences (AIIMS) across the country.
- Source: drugdu
- 546
- May 4, 2018
healthcare India New Approvals
AHA new digital health screening services to identify chronic disease risk

The American Heart Association, one of the leading non-profit organizations that foster cardiac care, is working to enhance community health through a new business line - Health Screening Services (HSS). The new health screening services will help consumers become more conscious of personal health risk factors and motivate them to make changes in their behaviors and lifestyle.
- Source: drugdu
- 640
- May 4, 2018
AMA digital health New Approvals
Tisagenlecleucel Granted FDA Approval for Large B-Cell Lymphoma

Based on data from the phase II JULIET study, tisagenlecleucel (Kymriah) has received FDA approval for the treatment of adult patients with relapsed/refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after 2 or more lines of systemic therapy.
- Source: targetedonc
- 3,693
- May 3, 2018
FDA New Approvals tisagenlecleucel
China hands out landmark nod with lightning speed

GSK’s Cervarix and Merck’s previous version of Gardasil took about 10 years to reach the Chinese market. (Merck)
- Source: fiercepharma
- 938
- May 2, 2018
CFDA Gardasil GSK New Approvals
AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis

In clinical studies, more than half of patients receiving risankizumab achieved complete skin clearance (PASI 100) at one year (52 weeks) (1) The Biologics License Application is supported by four Phase 3 studies of more than 2,000 patients with moderate to severe plaque psoriasis (1-3) Risankizumab is an investigational compound designed to selectively inhibit IL-23 by binding to its p19 subunit and is being evaluated for the potential to deliver long-term skin clearance for psoriasis patients with 12-week dosing (4)
- Source: prnewswire
- 659
- April 27, 2018
AbbVie FDA New Approvals plaque psoriasis
FDA to expedite review of IDx-DR, a breakthrough AI diagnostic system

IDx, a privately held AI diagnostics company, announced today that it has filed its De Novo submission to the FDA for IDx-DR, an AI-based system for the autonomous detection of diabetic retinopathy — a leading cause of blindness. The FDA has granted IDx-DR with a “Breakthrough Device” designation, which means the submission will receive expedited review.
- Source: prweb
- 673
- April 26, 2018
blindness diabetic retinopathy FDA IDx-DR New Approvals
Steth IO launches digital stethoscope housed within smartphone case

On Tuesday, Bothell, Washington-based Steth IO announced the launch of its smartphone-based digital stethoscope.
- Source: MobiHealthNews
- 850
- April 26, 2018
FDA medtech mHealth New Approvals

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