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Clinical / R & D

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Myriad Finishes Big Year With NICE Endorsement Of EndoPredict Breast Cancer Diagnostic

The UK's National Institute for Health and Care Excellence (NICE) has included Myriad Genetics' EndoPredict in its recommendations for guiding adjuvant chemotherapy decisions for certain early breast cancer patients. The recommendation comes just a few weeks after new data showing the long-term prognostic value of the EndoPredict test was presented at the San Antonio Breast Cancer Symposium. The company is also making progress on its Vectra rheumatoid arthritis prognostic system with the publication of a large commercial cohort and several clinical studies on development of the adjusted Vectra score.

Clinical Trials In Vitro Diagnostics Innovation
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Clinical Trials

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Latest From Clinical Trials

NZ To Replace 'Outdated And Piecemeal' Device Rules

There are significant changes in store for New Zealand’s medical device sector, including a new regulator and a set of pre- and post-market regulatory controls.

New Zealand Policy & Regulation

Results Recap: Pulse Biosciences Announces Results Of Sebaceous Hyperplasia Study

This week's edition of Medtech Insight's Results Recap, the weekly roundup of major device trial-results from Meddevicetracker.com, includes just one entry as the 2019 is off to a slow start for trial results announcements. Pulse Biosciences announced encouraging results from the clinical efficacy study of its Nano-Pulse Stimulation technology to treat patients with sebaceous hyperplasia.

Tracking Trials Research & Development

Starts & Stops: Abbott Stops Two-Clip Trial Of MitraClip; PROMISE Trial of Eversense XL CGM Begins

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Dec. 30 to Jan. 7, including announcements from Abbott, Roche, Insightec, and Terumo.

Starts & Stops Tracking Trials
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New Technology

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Latest From Innovation

Device Week, Jan. 18, 2019 - Key Topics At This Year's JP Morgan Healthcare Conference

On this week's podcast, Medtech Insight's Catherine Longworth chats with Marion Webb about some key takeaways from this year's JP Morgan Healthcare Conference. That includes a Q&A with Smith & Nephew's new CEO Namal Nawana on his growth strategy for the British medtech giant, new partnership announcements between medtech and tech companies, and trends in digital health.

Device Week Deals

QUOTED. Jan. 18, 2019. George Savage.

Proteus Digital Health announced a new partnership with Minneapolis-based Fairview Health Services and the University of Minnesota Health to prescribe "digital capecitabine," encapsulating the common chemotherapy drug with Proteus' sensor, to colorectal cancer patients. The goal is to achieve medication adherence, leading to enhanced treatment and outcomes, through home-based monitoring. See what George Savage, Proteus' co-founder and chief medical officer, had to say about the new digital oncology program here.

Quoted Commercial

Bringing A Digital Pill To Oncology: Proteus Partners With Health System To Prescribe Sensor-Enabled Chemotherapy

Proteus Digital Health announced a new partnership with Fairview Health Services and the University of Minnesota Health to prescribe capecitabine, a common chemotherapy drug, encapsulated with a sensor to colorectal cancer patients. Under the program, patients are prescribed the "digital capecitabine" and will be monitored remotely to see when they take their meds and for other health data. The goal is to improve patients' treatment adherence and improve outcomes.

Commercial Digital Health
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Approvals

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Latest From Approvals

2018 US Device Approvals: The Year Of De Novos And Digital Health

It was another record year for novel device approvals by US FDA, driven by the big uptick in de novo classifications for low-to-moderate-risk devices in 2018. Meanwhile, original PMA approvals dropped significantly. An analysis and infographic on FDA device approval trends in 2018.

Approvals FDA

2018 Global Approvals Analysis: Emerging-Market Regulators And Companies Make Their Presence Felt

The list of medical device approvals outside the US captured by Medtech Insight's Approvals Tracker in 2018 was shorter than in 2017, but it includes approvals from 14 different territories – more than one-fifth of the approvals came from emerging markets – covering more than 50 different indication categories.

Approvals Emerging Markets

Bruin Lands De Novo On Pressure Ulcer Assessment Tool

US FDA has granted a de novo clearance to Bruin Biometrics’ SEM Scanner, which is the first device cleared to assess parts of a patient’s body that may be at risk for pressure ulcers.

Approvals Wound Management
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