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Lilly Signs Deals With Dexcom, Glooko, myDiabby, Roche For Diabetes Management Solutions

Lilly announced it signed strategic international agreements with four diabetes companies to advance connected solutions and streamline care for people with diabetes in markets outside of the US.

Deals Digital Health Diabetic Care

BD Expects Alaris Infusion Pump To Return To US Market Next Year

The company stopped shipping Alaris in early 2020 after the FDA requested a new 510(k) for modifications and the device has been the subject of several recalls since then.

Recalls Launches Approvals

Q&A: Boston Scientific, BD, Steris Tell How They’re Backing Up Their Workers In ‘The New Normal’

Quality and regulatory officials at the three companies offer tips on supporting the mental health of employees, virtually onboarding new hires, and more in the age of COVID-19.

Trends Coronavirus COVID-19 Leadership

Execs On The Move: Occlutech Holding Revamps Board, VolitionRx Appoints New CEO

Bone Health Technologies appoints three new board members following $2.5m funding round, and Nanox Imaging appoints new chief business officer prior to commercial shipments.

Appointments Companies Commercial

How The EU Artificial Intelligence Regulation Will Overlap With Medical Device Regulations

Artificial intelligence is incorporated into medical devices and IVDs with increasing frequency. But it is only now that the EU is working on how that process will be regulated.

Artificial Intelligence Regulation EU

After QSR Delays, ‘It’s Full-Steam Ahead With That Proposed Regulation,’ FDA’s Shuren Vows

Jeff Shuren, director of the US FDA’s Center for Devices and Radiological Health, said on 6 May that the agency’s efforts around harmonizing its Quality System Regulation with ISO 13485 are “back on track.”

Regulation Standards FDA

Device Week, 7 May 2021 – New MDUFA, Old Disagreements

In this week’s podcast, senior reporter Ferdous Al-Faruque gives an early look at how user fee negotiations between the US FDA and industry groups for MDUFA V are unfolding. As in the past, the parties are at odds over how much industry should pay, and what the FDA is using the money for.

Device Week User Fees Regulation

Device Week Podcast

In This Episode:Smile Train And BioDigital Introduce App To Train Surgeons In Cleft Palate Repair

Listen to Medtech Insight podcasts for our perspectives on regulation, policy, quality, R&D and key commercial topics.

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Policy & Regulation Explore this Topic

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FDA’s Shuren: ‘Senior-Level Folks’ Will Take Part In New Inspectional Affairs Council

US FDA device center director Jeff Shuren on 6 May shed a tiny bit of light on the agency’s newly announced – but not defined – Inspectional Affairs Council.

FDA Enforcement Compliance

More Investment In AI Tops Near Term Agendas For Health Care Leaders

Two thirds of health care leaders today are increasing telehealth capabilities, but in three years’ time artificial intelligence will be their main priority, says Philips’ latest annual Future Health Index.

Innovation Artificial Intelligence Policy

Latest From Policy & Regulation

Exec Chat: Focus On Protecting Cybersecurity Vulnerabilities That Are Exploitable, Sternum CEO Says

Sternum recently announced a partnership with Medtronic to protect its legacy devices from cybersecurity threats. Medtech Insight chatted with its CEO Natali Tshuva about how her product works.

Exec Chat Regulation

EU Extends Scope Of Electronic IFU To Medical Device Software In First Update In Nine Years

For the first time in nine years, the European Commission looking at the extent to which IFU for medical devices may be made available electronically.

Europe EU

First Version Of Vital Eudamed Communication Support Tool Released

Stakeholders have access to the first version of the European Medical Device Nomenclature, an aid to identifying the precise type of device being referred to. And their views on the naming system are being sought too.

Europe EU

Doctor At Center Of Medtronic Meal Kickback Scheme To Pay $4.4M Settlement

The settlement resolves allegations the neurosurgeon collected kickbacks both for using Medtronic devices and for buying devices through his own distributorships.

Regulation Legal Issues

US Regulatory Roundup, April 2021: Medical Software, FDA Remote Reg Assessments, Medtronic Recalls, And More

An FDA rule that says the agency will no longer regulate eight different types of medical software, an explainer of the FDA’s Remote Regulatory Assessments, high-risk class I recalls for medtech giant Medtronic, and more topped our list of most-read Medtech Insight articles in April.

United States Regulation

GDP And UDI On List Of Regulatory Changes Under Taiwan Medical Device Act

Taiwan’s Medical Device Act was enforced on 1 May, bringing changes to good distribution practice and laying the foundation for UDI regulations.

Taiwan Asia Pacific

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

EU Extends Scope Of Electronic IFU To Medical Device Software In First Update In Nine Years

For the first time in nine years, the European Commission looking at the extent to which IFU for medical devices may be made available electronically.

Europe EU

At Best, FDA Will Carry Out Only Half Of Domestic Surveillance Inspections In FY 2021, Report Says

A 5 May report from the US FDA says that even under the most favorable COVID-19 conditions the agency’s inspections of makers of medical and tobacco products will likely be cut in half this fiscal year. The FDA also announced it will launch an agency-wide Inspectional Affairs Council to “plan and coordinate inspectional activities.”

FDA Enforcement

US Regulatory Roundup, April 2021: Medical Software, FDA Remote Reg Assessments, Medtronic Recalls, And More

An FDA rule that says the agency will no longer regulate eight different types of medical software, an explainer of the FDA’s Remote Regulatory Assessments, high-risk class I recalls for medtech giant Medtronic, and more topped our list of most-read Medtech Insight articles in April.

United States Regulation

OUTLOOK 2021

Forward-looking features and special content, including Scrip 100, Medtech 100 and Generics Top 50 industry rankings

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Commercial Explore this Topic

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BD Plans To Spin Off Diabetes Care Business

BD believes the independent new company will create shareholder value and is part of the BD 2025 growth strategy. 

Financing Diabetic Care Business Strategies

Latest From Commercial

Exec Chat: Focus On Protecting Cybersecurity Vulnerabilities That Are Exploitable, Sternum CEO Says

Sternum recently announced a partnership with Medtronic to protect its legacy devices from cybersecurity threats. Medtech Insight chatted with its CEO Natali Tshuva about how her product works.

Exec Chat Regulation

Dealmaking Quarterly Statistics, Q1 2021: Boston Scientific, Roche Start The Year With Billion-Dollar-Plus Acquisitions

During the first quarter, medical device company mergers and acquisition totalled $10.2bn, while in vitro diagnostic firms and research tools players completed M&A activity that totaled $5bn.

M & A Deals

NeoGenomics Bolsters Liquid Diagnostics Portfolio By Acquiring Inivata

Inivata will remain a separate liquid biopsy division alongside NeoGenomics’ growing clinical, pharma and informatics divisions.

M & A In Vitro Diagnostics

Slow Q1 For Baxter, But Board Remains Confident Of Turnaround

Baxter International recorded slight revenue increases during quarter one of 2021, with sales still impacted by COVID-19. Its board remains optimistic , pointing towards new product releases and “operational strength” as redeeming factors.

Sales & Earnings Coronavirus COVID-19

Labcorp Buys Myriad Genetics’ Vectra Autoimmune Test Business

Labcorp has agreed to pay $150m in cash for Myriad Genetics’ autoimmune business, one of three major units Myriad is unloading as it tries to narrow its focus to oncology, women's health and mental health diagnostics.

M & A In Vitro Diagnostics

Exec Chat: Inside Pelvalon’s Road To Medicare Reimbursement For Its Novel Femtech Device

Pelvalon CEO Miles Rosen talks the company’s journey from US FDA de novo authorization to Medicare HCPCS payment code for its Eclipse System, a nonsurgical device used for bowel control in women.

Exec Chat Reimbursement

Clinical R&D Explore this Topic

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Boston Scientific Beats Expectations In Q1

Among the company's many milestones in the first quarter, the FDA approved its Therasphere radiation seed device, a major building block of the company's interventional oncology business.

Sales & Earnings Cardiovascular Cancer

Latest From Research & Development

Exec Chat: Omron’s Hypertension Solutions Gain Traction With Shift To At-Home Patient Care

Omron is implementing its new VitalSight platform to physicians, hospitals for remote monitoring of high-risk hypertension patients at 50 US institutions and internationally. 

Exec Chat Digital Health

Medtronic Taps AR Technology Used By Fighter Pilots To Enhance Brain Surgery

Medtronic teamed up with Surgical Theater to integrate its SyncAR technology with its StealthStation S8 surgical navigation platform to help neurosurgeons navigate complex brain surgeries.

Surgery Neurology

Device Week, 23 April 2021 – SCOTUS Hears Major Patent Case; USPTO Encouraging COVID-19 Patent Applicants

In this week’s podcast, Medtech Insight managing editor Elizabeth Orr discusses the implications for medtech patent law from the US Supreme Court’s Minerva Surgical v. Hologic Inc. case, and senior reporter Ferdous Al-Faruque outlines the USPTO’s efforts to encourage inventors to file for COVID-19 product patents.

Device Week Policy

US FDA Authorizes Breakthrough Device For Stroke Patients

The agency has granted de novo authorization to Neurolutions’ IpsiHand System to help stroke victims rehabilitate the use of their upper extremity.

Approvals FDA

USPTO Giving Major Patent Incentives To COVID-19 Inventions – But There Aren’t Enough Takers

The government patent office has launched new COVID-19-related programs to get products to market faster and cheaper. But based on past experience, not a lot of companies are taking advantage of them.

Policy Research & Development

Zimmer Biomet Receives 510(k) Clearance For ROSA Partial Knee System

The ROSA Partial Knee is part of Zimmer Biomet’s connected intelligence suite, which provides key analytics to health providers throughout a patient’s care continuum.

Orthopedics Robotic Surgery
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