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Approvals

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US Approvals Analysis: Original PMA Slowdown, De Novo Upswing Among Recent Trends

The volume of original PMAs coming to US FDA for review is down recently, while panel-track supplement, de novo and 510(k) volumes are up. October, meanwhile, was a relatively light month for novel device approvals, but better-than-average for 510(k) clearances.

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US FDA Approves First Telehealth Option To Remotely Program Cochlear Implants

FDA approved a PMA supplement to remotely program sessions for Cochlear Americas' Nucleus Cochlear Implant System, heralding the feature as the first programming telehealth option for the hearing implants.

Ear, Nose & Throat Approvals

First ‘Digital Medicine’ Approved, Slow Rollout Planned

FDA has approved Abilify MyCite, a treatment for some psychiatric conditions that integrates a drug with a sensor that records when the medication is taken. The goal is to track medication compliance. It is an important regulatory milestone for the nascent field of digital medicine, but many questions about the market remain.

Medical Device Combination Products

US Approvals Analysis: Original PMA Slowdown, De Novo Upswing Among Recent Trends

The volume of original PMAs coming to US FDA for review is down recently, while panel-track supplement, de novo and 510(k) volumes are up. October, meanwhile, was a relatively light month for novel device approvals, but better-than-average for 510(k) clearances.

Approvals Innovation

Global Approvals Analysis: Diabetes, Drug-Eluting Stents Lead List Of Non-US Approvals in October

The CE Marks recorded in October include Abbott's new version of Xience and Medinol's BioNIR drug-eluting coronary stents, plus 18 other devices approved in eight different territories.

Approvals Innovation

Big Promise For TransEnterix Robotic-Surgery Device, But Probably Won't Undermine Intuitive's Market

FDA's recent clearance of TransEnterix's Senhance System signals broad potential for robotically-assisted surgeries but the device is more likely to grow its own space than compete directly with Intuitive Surgical's daVinci products in many cases, analysts suggest.

Approvals Gynecology & Urology

Device Designed To Improve Spine-Surgery Outcomes Gets FDA Panel Date

US FDA says its Orthopaedic and Rehabilitation Devices Panel will convene Dec. 12 to weigh issues surrounding ongoing review of Intrinsic Therapeutics' PMA for its Barricaid anular closure device, intended to close a hole created by a spine discectomy procedure to prevent negative outcomes.

Advisory Committees Approvals

Medtech Fees To Soar In Canada Under Government Proposals

The licence evaluation fee Health Canada charges for Class IV medical devices could jump from CAN$12,347-$22,560 to $30,063 under proposals by the government agency, which says the current fees it charges for medtech and pharma are outdated.

Approvals Canada

OUS Approvals Analysis: Abbott Announces Three Glucose Control CE Marks; iVascular Earns Five Approvals In India

Cardiovascular and diabetes device dominated September's list of medical device approvals from outside the US on Medtech Insight's Approvals Tracker. The 24 non-US approvals in September is below average for 2017, but one more than September of 2016 and keeps 2017 on a track to have about 40% more non-US approvals than 2016.

Approvals Innovation

US Approvals Analysis: Cook Churns Out 510(k)s In Q3

The privately held Indiana-based device firm has accelerated its 510(k)-clearance output this year, leading all firms with 19 in the third quarter, and pulling neck-and-neck with perennial leader Medtronic for 2017. Overall, FDA remains relatively steady on 510(k) volumes and is maintaining its accelerated pace of novel-device approvals.

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