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Virtual Reality: The New Game In Mental Health Care To Improve Outcomes

Virtual reality is seeing an upsurge in use by mental health practitioners for treating conditions such as post-traumatic stress disorder, panic disorders and anxiety in a safe and controlled manner. With the advent of affordable VR headsets and technological advances, companies and researchers worldwide are seizing on the opportunity to bring such techniques as VR exposure therapy and cognitive behavioral therapy to telemedicine, specialty clinics and directly to consumers to improve outcomes and better lives.

Neurology Innovation Market Intelligence

South African Medtech Reg: Pieces Coming Together, As August Deadline Approaches

South African medtech firms have been given until August 24 to license their business establishments and list (but not actually register) their products. There is controversy over the fees and a growing list of tasks for industry and the government, but the key pieces generally seeming to be falling into place to support standing up a South African medtech regulatory system.

South Africa Regulation Medical Device

UK Medtech Upscales International Plans Ahead of Brexit

As the UK prepared to leave the EU, the local medtech industry, represented by the Association of British Healthcare Industries, has been busy finding ways to make up for any potential restrictions on market access and business development. On June 21, it announced a three-year growth plan, as explained by ABHI managing director of international Paul Benton in this Medtech Insight podcast interview.

United Kingdom Brexit Market Access

Q&A: FDA Dx Reviewer's Tips For Next-Gen Sequencing Sponsors

A top reviewer in US FDA's in vitro diagnostics office offers tips to next-generation sequencing test sponsors to avoid common submission shortcomings in this interview with Medtech Insight. According to FDA's Hisani Madison, sponsors frequently fall short in providing a refined intended-use statement.

In Vitro Diagnostics Personalized Medicine Regulation
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Policy & Regulation Explore this Topic

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Compliance Corner: Keep 'ALCOA' In Mind To Ensure Quality Data Integrity, Says US FDA Expert

When inspecting a device manufacturing facility, FDA investigators will check a company's quality data to make sure it's Attributable, Legible, Contemporaneous, Original and Accurate – or "ALCOA," the agency's national device expert says.

Quality Control Compliance Medical Device

As Device Firms Take Costa Rica By Storm, Quality Control Experts Champion 'Pura Vida'

"Pura Vida" – a Spanish phrase meaning the "pure" or "simple life" – isn't just the unofficial motto of Costa Rica; rather, it's a state of mind, locals say. But as more and more medical device manufacturing facilities pop up in the tiny Central American nation, quality assurance professionals there have discovered that ensuring top-notch product quality doesn't necessarily make life simpler. To jump that hurdle, QA experts from a variety of firms – including Medtronic, Precision Concepts and Creganna Medical – have banded together to lean on each other as they search for solutions to quality systems issues, as well as knowledgeable input on hot quality and compliance topics.

Quality Control Compliance Costa Rica

US Trade Rep May Take Enforcement Actions Against India Over Device Price Controls

US Trade Representative Robert Lighthizer told Senate Finance Committee Chairman Orrin Hatch, R-Utah, that if India's ongoing practices to impose price controls on US device imports continue, he would consider "enforcement actions," if India's actions violated any World Trade Organization trading rules.

Cardiology Trade

Warning Letter Roundup & Recap – June 20, 2017

US FDA did not release any device-related warning letters the week of June 20.

Device Warning Letters Medical Device

US FDA Updates Clinical Trial e-Reporting, e-Signature Guidance To Keep Up With Tech

In a draft guidance on electronic signature and record requirements for clinical trials used to submit applications across FDA product centers, the agency responds to technological advances since it last issued guidelines almost 15 years ago, while keeping its narrow enforcement of the "Part 11" rules in place.

Regulation Clinical Trials

Device Lobbyists Support Device Tax Repeal in Senate Health Bill, As Providers Remain Opposed

AdvaMed members ratcheted up pressure on members of Congress last week to permanently abolish the device tax, be it in the Senate Affordable Care Act repeal bill, or any other way they can get it. Meanwhile, medical provider groups, including the American Medical Association, American Heart Association, and the American Hospital Association, are lobbying against the Senate's bill to prevent insurance coverage losses.

Policy Legislation

Medtech Summit: The Three Biggest Challenges Of The EU MDR

The EU's Medical Devices Regulation has entered into force, but there is still three years until it is fully applicable. Already there is a tidal wave of questions about some of the most critical elements. Will they be answered in time?

Europe Medical Device

South Africa Medtech Reg: As New System Nears Finish Line, Device-Drug Distinctions Still Need Highlighting

Stakeholders pushing for a dedicated medtech regulatory system in South Africa have been in sight of the finish line on several occasions in recent years, only for obstacles to rise. But a new structure is almost in place with the enactment of key rules this month. The country's device industry group, meanwhile, is still working to ensure the government fully appreciates important distinctions between devices and drugs.

South Africa Regulation

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Compliance Corner: US FDA Wants Device Firms To Fully Consider Risks To Consumers, Agency Expert Says

Manufacturers that don't consider all possible dangers their products can pose to consumers is a growing problem, FDA's national expert on devices says. Phil Pontikos also is worried that firms aren't putting their best foot forward when using risk assessment tools.

Risk Management Compliance

Zimmer Biomet Resolves Chinese Plant Warning Letter

The warning letter referred to CAPA and quality assurance issues at a surgical instruments manufacturing plant in China.

Quality Control Orthopedics

Class I Device-Makers Get Wiggle Room As US FDA Pushes UDI Compliance Date To 2020

Manufacturers of low-risk class I products were given an extra two years to comply with FDA's Unique Device Identification requirements to give the agency and industry time to work through challenges posed by incorporating device identifiers into electronic health systems.

Quality Control Compliance

Commercial Explore this Topic

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Philips Completes M&A Hat Trick With Neurodiagnostic Buy

In its third acquisition this year so far, Philips is buying neurodiagnostic firm Electrical Geodesics.

Neurology Diagnostics M & A

Latest From Commercial

Bonesupport Cements Funding With SEK 500m IPO

Swedish orthobiologics company Bonesupport has closed its initial public offering on the Nasdaq Stockholm exchange, raising SEK500m ($57m) from retail and institutional investors.

Orthopedics Financing

Stryker Doubles Down On Novadaq To Boost Medsurg

Stryker is set to expand its surgical offerings after signing a $701m deal to buy Novadaq Technologies, a leading developer of fluorescence surgical imaging technology. The acquisition price is a 96% premium over Novadaq's June 16 closing price, which, according to analysts, is believed to be due to a competitive bidding process for the company.

M & A Surgery

Olympus Settles Power Morcellation Suit

The company was sued by a Georgia woman who said the surgical tool allowed uterine cancer to spread throughout her abdomen. Terms of the settlement were not disclosed.

Legal Issues Medical Device

Pain Device Firm Sued for Securities Fraud

A venture capitalist who sunk $2m into the manufacturer of a device to treat phantom pain has filed suit, claiming the company was mismanaged and filed false securities statements.

Legal Issues Commercial

PerkinElmer Solidifies OUS Presence With $1.3bn EUROIMMUN Buy

In a bid to further grow its presence outside the US, especially in China and the emerging markets, PerkinElmer has inked a $1.3bn all-cash deal to buy German in vitro diagnostics multinational EUROIMMUN Medical Laboratory Diagnostics.

M & A In Vitro Diagnostics

How Israel's Digital Innovators Are Capturing The Minds Of Medtronic And Others

The positive growth trend seen in Israel's digital health industry is galvanizing big players like Medtronic into action to start developing and recognizing synergistic technologies for future business. Medtech Insight met with members of MindUP, Israel's first digital health incubator and the result of a cross-industry partnership, at the MiXiii Biomed conference in Tel Aviv, to discover how the joint venture is driving the next generation of digital innovations.

Digital Health Innovation

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Starts & Stops: Corlife's Decellularized Human Pulmonary Valve Shows Early Promise

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. News about trials of cardiovascular devices, especially novel heart valve replacement technologies, lead this month's edition, covering mid-May through mid-June.

Starts & Stops Clinical Trials Research & Development

Latest From Research & Development

Positive Data Give DePuy Synthes' Attune Further Knee-Up

Results of a study by the Canadian Radiostereometric Analysis Network show that the tibial base of DePuy Synthes' Attune knee replacement achieves stable fixation out to two years and recently announced results from the UK's National Joint Registry show a 98.1% four-year implant survivorship rate with Attune in a "real-world" setting.

Orthopedics Clinical Trials

Device Week – June 16, 2017

On this week's Medtech Insight podcast: expect digital health guidance documents from US FDA soon, the agency’s commissioner says; FDA optimistic it will push out a final version of a 3D printing manufacturing guidance this year; US government releases data on the number of people who would lose health insurance under the American Health Care Act; Wells Fargo report fingers which device types would be most impacted by Trumpcare; a look at FDA approval and clearance trends, including a noticeable increase in 510(k)s; new clinical data releases discussed.

FDA Digital Health

INS 2017: Neuromodulation's Future Features Innovative Power Source, Materials And Treatment Protocols

Neuromodulation technology is advancing at breakneck speed, as physicians, academic, and industry innovators deepen their understanding of the field and learn what works and what doesn't. At the Innovations Day held during the 13th world congress of the International Neuromodulation Society in Edinburgh, Scotland, Medtech Insight highlights the notable new techs that are in the pipeline of emerging companies.

Neurology Innovation

OUS Approvals Analysis: IVDs Lead A Slow Month

Only 10 approvals from outside the US were recorded in May in Medtech Insight's approvals tracker. Half of those were for in vitro diagnostics, including three for companion diagnostic for cancer drugs.

Approvals Innovation

Start-Up Spotlight: LensGen, Eye On The Presbyopia Prize

Restoring the eyes' ability to accommodate and seamlessly focus on near and far objects continues to be the holy grail in ophthalmology. Accommodating intraocular lenses offer one approach to tackle presbyopia and allow patients the possibility of eschewing reading glasses. LensGen is one company going down that road and it successfully raised $21m in series A financing – with major optical lens maker Hoya among its backers – in April to advance its fluid-based accommodating IOL, Juvene.

Ophthalmology Innovation

ASCO 2017: Myriad's MyRisk; Nanobiotix' NBTXR3; Chronix' CNI Test; Sirtex SIR-Spheres; ANGLE’s Parsortix CTC Harvester

Over 30,000 oncologists and other health professionals attended the 2017 American Society of Clinical Oncology annual meeting in Chicago, June 2-6. This year's meeting included several presentations on emerging cancer diagnostic and device treatment strategies, including genetic tests, liquid biopsy systems, radioenhancers, and microspheres intended to improve chemotherapy outcomes.

Cancer In Vitro Diagnostics
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