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Device Week

Set Alert for Device Week

Device Week – April 21, 2017

On this week's Medtech Insight podcast we highlight two big M&A deals: Abbott & Alere, and Medtronic & Cardinal Health.

Commercial Deals Medical Device

Device Week – April 14, 2017

On this week's Medtech Insight podcast: cybersecurity and US FDA warning letter headaches for St. Jude; a conversation with AdvaMed CEO Scott Whitaker; a profile of device-maker InVivo Therapeutics, which is looking to leverage 2tst Century Cures provisions; a verdict was reached in a Kimberly-Clark fraud suit; comments roll in on the Diagnostic Accuracy and Innovation Act in the US; and more.

Regulation Policy

Device Week – April 7, 2017

On this week's podcast, we checked in on Q1 2017 trends that we have spotted in Medtech Insight's online data trackers for venture funding, M&A and global product approvals.

Medical Device In Vitro Diagnostics

Device Week – March 31, 2017

On this week's podcast, we discuss the disappointing data news that has come in recent weeks for Abbott Labs' Absorb BVS bioresorbable scaffold; the latest user-fee reauthorization hearing on Capitol Hill; our interview with outgoing AdvaMed chair Vince Forlenza; and deep-dives into compliance and IP challenges facing the digital medtech space.

Device Week Research & Development

Device Week – March 24, 2017

On this week's Medtech Insight podcast: the latest on efforts to repeal and replace the Affordable Care Act; reauthorization of MDUFA IV coming along; user fees for device reviews proposed by Trump administration; device firms advised to keep an eye on pricing policies in China; new R&D developments; orthopedic companies gather at the American Academy of Orthopedic Surgeons annual conference; and more.

Regulation Policy

Device Week – Mar. 17, 2017

On this week's Medtech Insight podcast: President Trump releases budget "blueprint" calling for cuts in many US agencies, including FDA; class II designations formalized by FDA for a slew of important products; FDA proposes exempting from 510(k) requirements hundreds of class II devices; a new surgical robotic project wins a €4m grant from European Commission; an update from the American College of Cardiology annual scientific sessions.

FDA Medical Device

Device Week – March 10, 2017

On this week's podcast, we discussed a controversial modification to FDA's definition of "intended use," patent issues with Boston Scientific’s Lotus valve, the Republican bill to replace the Affordable Care Act and some disappointing clinical trial data that was presented at the annual Society of Interventional Radiology conference.

Device Week Medical Device

Device Week – March 3, 2017

Pan-cancer screening test developer Grail bags more than $1bn in funding; Trump bashes US FDA; fight likely in Senate over Seema Verma's appointment to head CMS; "FDA Precheck" floated by agency; a deep-dive look into the surgical robot market.

FDA Commercial

Device Week – Feb. 24, 2017

On this week's Medtech Insight podcast: the response by a US FDA advisory panel to Claret Medical's de novo submission for the first brain-filter device intended to protect patients undergoing transcatheter aortic heart valve replacement; a reporting trip to the Israeli innovation hub; a Boston Scientific recall; and bariatric surgery data.

Device Week Metabolic

Device Week – Feb. 17, 2017

On this week's Medtech Insight podcast: US House Ways and Means Committee sets out plans for the next two years, including a review of all taxes and fees connected to the Affordable Care Act; Allergan and Hologic enter into separate big-money acquisitions in the aesthetics devices arena; a deep-dive look at the osteoporosis diagnostics market.

Regulation Policy
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