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IVDR Notified Body Numbers – Has Enough Progress Been Made?

Will there be enough resources for IVD manufacturers to be audited in time against the EU's IVD Regulation? A survey from TEAM-NB reveals a drop in notified body numbers just at a time when more resources are needed.

Medical Device Europe In Vitro Diagnostics

Compliance Corner: J&J Quality Expert Urges Makers Of Combo Products To Be 'Bilingual' In Device- And Drug-Speak

Speaking the language of both devices and drugs is an important step sometimes missed by makers of combination products. Being "bilingual" is especially important during a facility inspection by US FDA, Johnson & Johnson's Susan Neadle says.

Compliance Corner Combination Products Enforcement

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 Cancer

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

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 Digital Health

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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

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Paclitaxel-Coated PAD Devices Under US FDA Scrutiny

The agency sent a letter to health-care providers stating that it is investigating reports of an elevated risk of death for patients starting two years after treatment with paclitaxel-coated balloons or paclitaxel-eluting stents. But FDA is not taking any regulatory action at this point.

Safety Regulation Post Market Regulation & Studies

Coordinated Antimicrobial Drug/Device Development Addressed In FDA Final Guidance

In its bid to fight antimicrobial resistance, the agency has finalized a 2016 guidance on how novel antibiotic developers can coordinate with antimicrobial susceptibility test-makers to ensure their products come to market at about the same time. The agency recommends using its pre-submission process for a more efficient review.

Regulation In Vitro Diagnostics Infectious Diseases

AdvaMed Code Update Focuses On Compliance Standards

AdvaMed has revised its industry Code of Ethics. The revised code, which will come into effect in 2020, includes new sections on off-label communications and training health-care professionals to use new medical technology.

Compliance Medical Device

DTC Ads For Genetic Tests Increased 18-Fold Over 20 Years, Study Says

The number of direct-to-consumer advertisements for molecular-based tests rose exponentially from 1997 to 2016, according to a medical marketing analysis released earlier this month in the Journal of the American Medical Association. Simultaneously, laboratory test manufacturers increased spending on ads and direct spending on physicians who work with the tests from $75.4m to $82.6m.

In Vitro Diagnostics Advertising, Marketing & Sales

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

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

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

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

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

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

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

Commercial Explore this Topic

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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

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

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

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 M & A

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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