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Device Week

Set Alert for Device Week

Device Week – Global Regulations Update, Aug. 9, 2017

Want to know more about medtech regulatory efforts in countries from Singapore to Myanmar to Russia, and more in between? In this week's podcast, Ashley Yeo provides an update from his reporting on what governments in the Asia and Eurasia regions are doing to focus oversight on devices and diagnostics. The short answer: A lot.

Regulation Device Week Asia Pacific

Device Week – The Summer Of M&As, Aug. 21, 2017

In this week's Device Week podcast, we look at recent mergers and acquisitions. While the year started out slow, July was the busiest month for medtech M&A deals. At this rate the industry is set to break last year's deal count. We go in-depth into some of the major deals, and more.

Device Week M & A

Device Week – Earnings Review, Aug 4, 2017

With earnings season in full swing, Tina Tan and Reed Miller of Medtech Insight review the performances of companies across the orthopedics sector and throw the spotlight on some big medtech pureplays and diversified health care firms.

Sales & Earnings Medical Device

Device Week – US Policy Roundup, July 28, 2017

In this week's podcast, Medtech Insight journalists discuss what was a busy week in Washington, DC: The health-care failure on Capitol Hill, and what it means for medtech; FDA's new plan for digital health; and one case to watch during the US Supreme Court's next term.

United States Policy

Device Week – July 21, 2017

On this week's Medtech Insight podcast: US Senate passes $2.8bn FDA spending bill; US approvals and clearances strong in first six months of 2017; the global heart-valve repair and replacement devices market is highlighted.

Medical Device FDA

Device Week – July 14, 2017

On this week's Medtech Insight podcast: FDARA user-fee bill progresses in the US Congress; a deep-dive look into the US Open Payments database yields interesting news and trends; in an unusual step, US FDA publicly shares 483 inspection observation form after troublesome Magellan Diagnostics audit; standards organization GS1 and the Healthcare Industry Distributors Association try to solve billing headaches; top management shaken up at Zimmer Biomet.

Compliance Regulation

Device Week – July 7, 2017

On this week's Medtech Insight podcast: supply-chain oversight program MedAccred makes a splash in industry; first diagnostic to use flow cytometry to detect rare blood cancers wins US FDA clearance; Ethicon sues Intuitive over surgical tool patents; Konica Minolta snaps up Ambry Genetics for $1bn; “Petya” and “Wannacry” ransomware attacks concern industry; a Thermo Fisher leader talks with Medtech Insight about the regulatory experience surrounding its Oncomine Dx Target Test.

Medical Device Quality

Device Week – June 30, 2017

On this week's 100th Medtech Insight podcast: a new value-based reimbursement scheme emerges between Medtronic and Aetna; a major escalation in cybersecurity threats to medical devices concerns industry; the US Senate plans to keep the device tax repeal in its reworked health-care bill; a look at US FDA funding; two innovative device companies are spotlighted; medtech legal advocates want to bring FDA’s 510(k) process before the Supreme Court; virtual reality therapy gains traction.

Medical Device Companies

Device Week – June 23, 2017

On this week's Medtech Insight podcast: US congressional hearing highlights India’s efforts to place price caps on foreign-made devices; Senate health-care bill nixes device tax; Costa Rican quality control experts lean on each other for industry education; US FDA issues a draft guidance on electronic records and signatures.

FDA Quality

Device Week – June 16, 2017

On this week's Medtech Insight podcast: expect digital health guidance documents from US FDA soon, the agency’s commissioner says; FDA optimistic it will push out a final version of a 3D printing manufacturing guidance this year; US government releases data on the number of people who would lose health insurance under the American Health Care Act; Wells Fargo report fingers which device types would be most impacted by Trumpcare; a look at FDA approval and clearance trends, including a noticeable increase in 510(k)s; new clinical data releases discussed.

FDA Digital Health
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