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Global content from trusted experts
More than a dozen experienced journalists and analysts based in Europe, US, and Asia bring you real-time analysis, news and opinion across the medtech landscape – covering regulatory, product and company developments.
Medtech Insight
By Shawn M. Schmitt 23 Aug 2019
US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.
Topic Policy and regulation
Medtech Insight
By Amanda Maxwell 23 Aug 2019
The European Commission updates its rolling plan on progress with key document and structures toward implementation of the new medtech regulations every few months. What is new and what is still to come this year?
Medtech Insight
By Shawn M. Schmitt 14 Aug 2019
Phil Pontikos, who is also the US agency's national device expert, explains how device-makers can avoid running afoul of the FDA's rules and expectations for sterilization activities.
Topic FDA
Medtech Insight
By Sue Darcey 14 Aug 2019
The US Medicare agency has been scrutinizing two new devices that have generated some buzz within the industry for pass-through payment status under its proposed 2020 Outpatient Prospective Payment System (OPPS) rules. The devices are Procept BioRobotic’s AquaBeam System for removal of prostate tissue in men with urinary tract symptoms, and Boston Scientific’s Eluvia drug-eluting stent for treatment of peripheral artery disease.
Topic Medtech
Medtech Insight
06 Aug 2019
US FDA says as artificial intelligence and machine learning offer new opportunities to improve patient care, the agency hopes to encourage innovation by developing a draft guidance on the issue for sponsors. It also released a discussion paper outlining key issues it wants feedback on from industry and other key stakeholders.
Topic FDA Digital Health Medtech
Medtech Insight
By Catherine Longworth 06 Aug 2019
Cancer diagnostics company Exact Sciences is combining with Genomic Health in a major merger valued at $2.8bn. The combined company will offer two of the fastest growing brands in cancer diagnostics, Cologuard and Oncotype DX.
Topic Cancer Business strategies
Medtech Insight
By Marion Webb 30 Jul 2019
Accelerating technological innovation, reimbursement and legislative changes are expected to make a significant impact on the global market of injection devices and related products. According to Informa's new Meddevicetracker report on "Infection Control and Biosafety Products," the combined market of these devices will reach $4bn by 2023.
Topic Medtech BioPharmaceutical
Medtech Insight
By Shawn M. Schmitt 26 Jul 2019
The fear of losing business by being transparent about cybersecurity vulnerabilities means there's "a perverse incentive in some parts of the market that encourages a lack of disclosure," Siemens' Harrison Wadsworth says. But the US FDA's Suzanne Schwartz believes coordinated vulnerability disclosure legislation could "level the playing field."
Medtech Insight
By Ferdous Al-Faruque 26 Jul 2019
In a midyear update from the FDA, regulators say a retrospective review of companies in its pre-cert pilot program has concluded that evaluating a company for excellence markers could be sufficient to let Software as a Medical Device (SaMD) onto the market. However, at least one critic says the update doesn’t answer some of the most critical questions about whether the program meets the agency's own requirements and if it creates unfair advantages for certain companies.
Topic FDA Policy and regulation
Medtech Insight
By Marion Webb 12 Jul 2019
This year, Omron Healthcare launched its new HeartGuide smartwatch and the first FDA-cleared blood pressure monitor with EKG capability. Medtech Insight sat down with Omron's CEO Ranndy Kellogg to learn about upcoming plans.
Topic FDA Digital Health
Medtech Insight
By Shawn M. Schmitt 12 Jul 2019
The US agency's Case for Quality Voluntary Improvement Program – used to measure a device-maker's manufacturing maturity and quality – has surprisingly been used to assess some pharmaceutical facilities. Meanwhile, regulators from other countries have been reaching out informally to the FDA to learn more about CFQ VIP.
Topic FDA Policy and regulation
Medtech Insight
By Bernard Murphy 05 Jul 2019
Enhancing trust in medical devices and medtech companies is the aim of a new agreement between the Spanish medtech industry and an organization specializing in helping businesses meet and maintain high legal and ethical standards.
Medtech Insight
By Amanda Maxwell 05 Jul 2019
The European Commission came under a great deal of pressure in June to deliver the fundamental structures and documents needed for implementing the EU’s new medtech regulations. It has hit the ground running so far this month.
Topic Policy and regulation
Medtech Insight
By Amanda Maxwell 03 Jul 2019
The recent no-deal Brexit notice from the UK government says that companies selling devices in the UK would need a "Responsible Person" in the UK if the firm is not based there. The government clarifies to Medtech Insight that such person must be physically present in the UK, and not simply have an address there.
Topic Brexit
Medtech Insight
By Ian Schofield 03 Jul 2019
Changes are being made to the UK’s Accelerated Access Collaborative to help streamline access to ground-breaking medicines and diagnostic tools in areas like dementia, diabetes and cancer.
Medtech Insight
17 Sep 2019
Medtech Insight
17 Sep 2019
Medtech Insight
16 Sep 2019
Medtech Insight
16 Sep 2019
Medtech Insight
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Medtech Insight
13 Sep 2019
Medtech Insight
13 Sep 2019
Medtech Insight
13 Sep 2019
Medtech Insight
13 Sep 2019
Medtech Insight
13 Sep 2019
Medtech Insight
12 Sep 2019
Medtech Insight
12 Sep 2019
Medtech Insight
12 Sep 2019
Medtech Insight
12 Sep 2019
Medtech Insight
12 Sep 2019
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