Latest Biotechnology, Pharmaceutical and Healthcare News from SmartBrief

06:41 EDT 15th August 2018 | BioPortfolio

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Showing News Articles 1–25 of 3,600+ from SmartBrief

Tuesday 14th August 2018

Believe that life is worth living, and your belief will help create the fact.

William James, philosopher and psychologist

FDA OKs Ivantis' microinvasive glaucoma surgical device

Ivantis has secured approval from the FDA for its Hydrus Microstent, designed to be used in conjunction with cataract surgery -More- 

Utah congresswoman wants permanent action against medical device tax

Rep.  -More- 

FDA clears 7D Surgical's machine-vision image guided surgery system

The FDA has given 7D Surgical 510(k) clearance for its machine-vision image guided surgery system for cranial surgery.  -More- 

GI Dynamics' EndoBarrier gets IDE from FDA

The FDA has given investigational device exemption approval for a pivotal trial of GI Dynamics' EndoBarrier device, a plastic -More- 

Scientists create hemodialysis catheter placement device

An insertion support device designed to improve placement of tunneled cuffed catheters for hemodialysis was developed by rese -More- 

The 10 most innovative medical devices of 2018

The nominees for the best medical technology of 2018 were recently announced for the 12th Annual Prix Galien USA Awards.  -More- 

Former Abbott exec named SetPoint president, CEO

Murthy Simhambhatla, a former Abbott executive, was appointed by SetPoint Medical as president and CEO.  -More- 

Endologix updates timeline for FDA approval of Nellix stent graft

Endologix has pushed its timeline for FDA premarket approval of its Nellix 3.5 endovascular sealing system to the first half  -More- 

MacuLogix gets $10M boost

Middletown, Pa.-based medtech company MacuLogix has secured a Horizon Technology Finance-led loan facility valued at $10 mill -More- 

HSBC provides $17M credit facility to Covalon Tech

Covalon Technologies has reached an agreement with HSBC for a $17 million credit facility that will be used to support its op -More- 

AdvaMed raises concerns about draft HDE program guidance

AdvaMed released comments on the FDA's draft guidance on the humanitarian device exemption program, noting a lack of clarity  -More- 

Monday 13th August 2018

It's bad policy to speculate on what you'll do if a plan fails, when you're trying to make a plan work.

Condoleezza Rice, diplomat and political scientist

FDA extends deadline for GUDID compliance for some combo products

The FDA has extended the deadline for the submission of unique device identifier data into the Global Unique Device Identific -More- 

FDA authorizes marketing of NaturalCycles' contraceptive app

The FDA has granted NaturalCycles Nordic permission to market its Natural Cycles app, a contraception method designed for pre -More- 

Study examines efficacy of artificial pancreas in type 2 diabetes

Researchers in Switzerland and the UK found that type 2 diabetes patients who used an artificial pancreas had significantly b -More- 

Medtronic announces launch of cardioverter defibrillator system study

A pilot study of Medtronic's Extravascular Implantable cardioverter defibrillator system has begun, with the first implantati -More- 

Worldwide liquid biopsy market poised for growth, report shows

A Meddevicetracker report predicts the global liquid biopsy market will reach $2 billion by 2022 at a compound annual growth  -More- 

EKF Dx, McKesson Medical-Surgical enter US distribution deal

An agreement has been reached by EKF Diagnostics with McKesson Medical-Surgical for the US distribution of the DiaSpect Tm re -More- 

Israeli sleep apnea Dx device maker plans to list on Nasdaq

Israel-based Itamar Medical has filed a request with the Securities and Exchange Commission to be listed for trading on Nasda -More- 

Dexcom sees Q2 sales growth after G6 CGM release

Dexcom generated 42% higher year-over-year sales in the second quarter after the June launch of its G6 integrated continuous  -More- 

Insulet exec plans to upend diabetes care

Insulet CEO Patrick Sullivan says he plans to make Insulet a billion-dollar company focused on making lives of patients with  -More- 

Researchers use CRISPR to improve biofuel yield using yeast

By using the CRISPR gene-editing tool to alter two of the more than 12 million nucleotides in the yeast genome, scientists fr -More- 

Is gene editing the future of agriculture?

Startups such as Calyxt are leading the way as companies apply gene-editing techniques to soybeans and other crops.  -More- 

Follow-on funding pulls in $175.5M for RegenxBio

A follow-on funding pulled in $175.5 million for RegenxBio, which has an ongoing Phase I/II study of RGX-501 for the treatmen -More- 

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