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Featured Stories


Random Checks Now Routine: China To Inspect Your Factories Near And Far

A new regulation in China legalizes overseas inspections of device- and drug-makers, making risk-based audits routine tasks.

China Manufacturing Compliance

Complaints From Local Industry Reach New Heights In Turkey As Medtech Tender Gets Fourth Postponement

The planned $10bn medical device tender in Turkey, closely watched by multinational and local companies alike, has been postponed, again, until April 16. Local Turkish device companies are objecting strongly to the government’s approach to the tender, arguing that it is adding more pressure on local industry as it is already under serious financial distress.

Turkey Commercial Healthcare Systems

Expect FDA Diagnostics-Reform Bill Passage In 2019, Rep. DeGette Says

Passage of a US FDA diagnostics reform bill is one priority for the US House Energy and Commerce Committee in 2019, said cosponsor and committee member Rep. Diana Degette, D-Colo.

Legislation In Vitro Diagnostics Regulation

Edwards Pays Boston Scientific $180M In TAVR Patent Settlement

Edwards Lifesciences and Boston Scientific announced this week that the firms had resolved an ongoing global patent dispute.

Medical Device Cardiology Intellectual Property

QUOTED. Jan. 17, 2019. Nicholas Berg.

New Mexican president Andrés Manuel López Obrador, a member of the National Regeneration Movement (MORENA) party, has swept the office on an anticorruption platform. Some observers expect his efforts to include reforms and increased regulation touching the medical device sector. Nicholas Berg, an attorney with Ropes & Gray, said that in the past Mexico has made limited efforts to combat public corruption. See his advice for medtech companies planning on doing business in Mexico here.

Mexico Compliance Enforcement

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Optimizing Product Lifecycle Management With Real-World Evidence

An increasingly data-rich healthcare sector presents both opportunities and challenges for the MedTech industry, just as it does for the health systems and patients served by MedTech products. Used intelligently and appropriately, the vast quantities of real-world data emanating from multiple healthcare sources provide the raw material for real-world evidence (RWE) that can inform strategy and decision-making throughout the MedTech-product lifecycle.

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Policy & Regulation Explore this Topic

Set Alert for Policy

Swissmedic Updates Class I Medical Device Notifications, Levies Fees

Cost-recovery requirements have induced regulator Swissmedic to introduce notification fees for lower-risk, class I devices, IVDs and products that use non-viable human tissues, with immediate effect.

Switzerland Regulation Medical Device

New Anti-Corruption Focus In Mexico May Include Medtech Scrutiny

Recently inaugurated Mexican President Andrés Manuel López Obrador campaigned on a promise to tackle the country’s corruption issues. Medtech Insight spoke to attorney Nicholas Berg, of Ropes & Gray, about what this may mean for device manufacturers doing business in Mexico.

Mexico Compliance Enforcement

QUOTED. Jan. 16, 2019. Bradley Thompson.

US FDA is taking a cautious approach to rolling out the test phase of its pre-certification program for digital health products to keep it within legal limits. See what Bradley Merrill Thompson, an attorney at Epstein Becker & Green, had to say about the limited scope of the current plan here.

Quoted Digital Health

Warning Letter Roundup & Recap – Jan. 15, 2019

No device-related warning letters were released by US FDA the week of Jan. 15.

Device Warning Letters FDA

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

About Three Months' Worth Of Carryover Device Fees Remaining, FDA's Gottlieb Says

US FDA has about three months' worth of medical device carryover user-fee funds to burn if the partial federal government shutdown continues, although the agency is still finalizing its shutdown balance sheet, Commissioner Scott Gottlieb says.

FDA Regulation

Pre-Cert Program Will Start Off Slow With De Novo Framing, But Big Questions Remain

Several experts suggest FDA is toeing the line in keeping the first stage of its pre-certification program for software-as-a-medical-device products legally permissible, but it may be limited in scope for the time being. Meanwhile, one attorney says the agency is sending mixed messages about whether the current program will sit comfortably within FDA's current authorities.

Digital Health Regulation

New Finance Chair Grassley Will Push Device Tax Repeal, Try To Lower Health-Care Costs

In setting his agenda for the US Senate Finance Committee in 2019, incoming Chairman Chuck Grassley, R-Iowa, says he will continue to cosponsor bills to end the device tax, focus on lowering prescription drugs and other medical product health-care costs, expand tax breaks for business, and make sure Congress has a strong hand in negotiating trade and tariff talks.

Legislation Regulation

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

Benefit-Risk Is Front-And-Center In Latest Revision Of International Risk Management Standard ISO 14971

The International Organization for Standardization (ISO) has strengthened benefit-risk language in the latest redo of ISO 14971, the voluntary standard that instructs device-makers on how to best put together a risk management program. Regulators – including US FDA – are increasingly considering benefit-risk when weighing product availability and regulatory compliance issues. And Jos Van Vroonhoven, convener of a joint working group that revised the standard, says a more global regulatory emphasis on risk management and a desire to clarify the document in general led ISO to revise the standard. Also: Van Vroonhoven identifies four updated clauses in the revamped standard that firms should keep a sharp eye on.

Risk Management Standards

The Path Forward: Retooled Technical Doc TR 24971 Guides Device Firms On Risk Management Standard ISO 14971

When ISO TR 24971 – a Technical Report that offers device-makers guidance on international risk management standard ISO 14971 – was first published in 2013, not many people knew it existed. But now that the TR is being updated in tandem with ISO 14971, it's a must-have document that includes valuable instruction related to a host of risk-related issues. In particular, TR 24971:20XX includes informative new annexes that tackle device cybersecurity and how firms should handle risk management for products designed before ISO 14971 existed.

Risk Management Standards

Crosswalk: ISO 14971:2007 Vs. ISO 14971:20XX

Here's a table cross-referencing the current 2007 version of international risk management standard ISO 14971 and its revised draft version, which will likely be published by the International Organization for Standardization (ISO) later this year.

Risk Management Standards

Commercial Explore this Topic

Set Alert for Commercial

20-Year Sentence Upheld For ArthroCare Exec

The Fifth Circuit Court of Appeals has rejected former ArthroCare CEO Michael Baker’s appeal of a 20-year sentence. Baker was convicted on charges related to a $750m fraud case.

Medical Device Commercial Legal Issues

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

Abbott Advances Transcath Mitral Valve Efforts With Cephea Acquisition

Abbott has exercised an option to buy Cephea Valve Technologies, developer of a minimally-invasive replacement heart valve, for an undisclosed sum.

Cardiovascular M & A

Execs On The Move: Shockwave, Natera Updates

Prenatal testing firm Natera appoints a new chief operating officer and interventional cardiovascular device firm Shockwave Medical seats a new board chairman, among recent medtech and biotech personnel moves.

Appointments Commercial

Medtech Money Flow: M&A & VC Deals, Jan. 7-13, 2019

This edition of Medtech Money Flow rounds up the M&A and venture financing deals, as recorded in our M&A and VC Deal Trackers, from Jan. 7-13, 2019.

M & A Financing

QUOTED. Jan. 15, 2019. Namal Nawana.

The new CEO of Smith & Nephew, Namal Nawana, sat down with Medtech Insight during the JP Morgan Healthcare Conference to discuss his plans for putting the British medical giant on track for growth. See what he had to say here about the company's M&A strategy.

Commercial Exec Chat

Exec Chat: New Smith & Nephew CEO Namal Nawana Outlines Growth Strategy At JP Morgan

About eight months into his role as CEO of Smith & Nephew, Namal Nawana has revamped the firm's leadership team and created strategic imperatives to put the British medical device giant on the growth track. Medtech Insight sat down with Nawana at this year's JP Morgan Healthcare Conference in San Francisco to learn more about his plans for growing Smith & Nephew.

Commercial Exec Chat

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

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 Digital Health

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

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

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

Global Device Approvals, Weekly Snapshot: Endovascular Entries

A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. Terumo and Cook each nabbed US FDA approvals for endovascular devices.

Approvals 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

Starts & Stops: Vectorious Launches First-In-Human Trial Of V-LAP Left-Atrial Monitor

Starts & Stops compiles all the clinical trial announcements, initiations, completions and suspensions tracked by Meddevicetracker. This edition covers trial announcements from Dec. 24-30, so there is just one entry this week - Vectorious' announcement of the first-in-human trial of the V-LAP left-atrial monitor.

Starts & Stops Tracking Trials
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