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78 Total results for product and free and sample content found

Medtech Insight: 世界の医療機器・医療技術の最新情報

Device Tax-Repeal Bill Introduced In House With 227 Co-Sponsors

By Sue Darcey 11 Apr 2019

US House Representatives Ron Kind, D-Wis., and Jackie Walorski, R-Ind., have introduced a permanent medical device tax-repeal bill, alongside 225 co-sponsors from both parties.

Topic medtech

Medtech Insight: 世界の医療機器・医療技術の最新情報

If You Build It, They Will Come: FDAer Says Pre-Cert Program Getting Global Attention, AI Paper Just the Start

By ferdous-al-faruque 11 Apr 2019

International regulators are interested in seeing how they too can apply the US FDA’s precertification program, which is currently in the pilot stage. In an exclusive interview with Medtech Insight, the agency’s top digital health officer, Bakul Patel, talks about global curiosity about the program that could allow companies to get certain medical software on the market based on trust. Patel also expects an upcoming artificial intelligence draft guidance from the FDA will form from a recent discussion paper – but he says industry needs to do more.

Topic medtech

Medtech Insight: 世界の医療機器・医療技術の最新情報

Start-Up Spotlight: Innovative Cardiovascular Solutions Hopes To Win Regulatory Nod For Embolic Protector For TAVR

By Bob Kronemyer 22 Mar 2019

Transcatheter aortic valve replacement (TAVR) is performed routinely using devices providing protection from stroke as standard of care. However, cerebral embolic protection devices currently available do not capture and remove emboli from all three vessels leading to the brain. The Emblok Embolic Protection System from Innovative Cardiovascular Solutions (ICS) has developed an embolic filter designed to protect all three cerebral vessels during TAVR and remove debris from the entire circulatory system.

Topic Medtech

Meddevicetracker: 医療機器の市場調査分析・データベース

Meddevicetracker's Real-time Device Market Data API Solution

13 Mar 2019

Bringing our trusted data to your systems – fast.

Topic Medtech

Medtech Insight: 世界の医療機器・医療技術の最新情報

Drug-Coating Safety Risk Acknowledged At Cardiology Gathering, But Cause Remains Elusive

By elizabeth-orr 07 Mar 2019

Physicians and researchers in an all-day session at the Cardiovascular Research Technologies conference in Washington, DC, on March 5 largely backed the recent finding that paclitaxel-coated balloons and stents may be tied to a higher patient mortality rate. But the specific mechanism underlying the deaths remains unknown.

Topic medtech

Medtech Insight: 世界の医療機器・医療技術の最新情報

4C Medical Plans First Early Feasibility Study For An Implantable In Japan

By elizabeth-orr 07 Mar 2019

4C Medical plans to conduct both an early feasibility study and the pivotal trial for its mitral regurgitation treatment device simultaneously in Japan, the US and Canada. The company says the study is the first early feasibility study in Japan for an implantable device.

Topic medtech

Medtech Insight: 世界の医療機器・医療技術の最新情報

GE Deals Biopharma Biz To Danaher For $21.4Bn; Planned Healthcare IPO Probably Won't Happen

27 Feb 2019

The proposed IPO for GE's healthcare business could be off the table, CEO Lawrence Culp said as GE announced plans to sell its biopharma business to Danaher for $21.4bn. The deal will provide the conglomerate with a much needed cash injection to handle its rising debts.

Topic BioPharmaceutical Medtech

Medtech Insight: 世界の医療機器・医療技術の最新情報

Medical Device Registration In UK Under A No Deal Brexit Questions Answered

27 Feb 2019

The UK government is introducing new registration requirements for medical devices in the event of a no-deal Brexit. They will be rolled out according to the risk class of products. But some fundamental questions have arisen.

Topic Brexit Medtech

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