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How TÜV SÜD Issued First Certificate Issued Under EU’s IVD Regulation And Why It Matters

Notified body TÜV SÜD has issued the first certificate under the EU’s IVD Regulation. The notified body has fundamental advice for manufacturers wanting to ensure their IVDs are compliant in time.

Europe EU Compliance

Google Teams Up With Mayo Clinic To Explore AI To Improve Radiotherapy Planning

Mayo Clinic announces AI-based partnerships with Google and voice-analysis company Vocalis Health this week.

Cancer Artificial Intelligence Innovation

Boston Scientific Exceeds Wall Street’s Expectations In Q3

Boston Scientific’s management believes the ongoing recovery of procedure volumes and new technology will allow it to show revenue growth in the fourth quarter.

Sales & Earnings Commercial Coronavirus COVID-19

APACMed 2020: Dynamic China Market Will Heed COVID-19 Lessons For System Improvement In '21

To the watching world, China dealt quickly and firmly with COVID-19. Seen from within, the health care system is still adapting to the pandemic, but the government is taking the longer view.

China Coronavirus COVID-19 Medical Device

US Lawmakers Push Congressional Leaders To Better Prepare For Future Pandemics

Working with international health groups and ramping up supply chains for preventive equipment and tests will soften the blow of future pandemics, more than 130 Democratic legislators say.

Policy Legislation Coronavirus COVID-19

Court Tosses Manufacturer’s Bid For Medicare Coverage

The US Court of Appeals for the Ninth Circuit found that Sensory NeuroStimulation Inc., which makes a device to treat restless leg syndrome, hadn’t exhausted all administrative remedies.

Legal Issues Medicare Policy

CMS Sets Insurers’ Deadlines To Comply With Final Health Care Price Transparency Rule

A final Medicare agency rule requiring insurers to reveal coverage prices for device-related procedures and tests will let consumers shop health services.

Policy Medicare Cost Effectiveness

Infographic: Sleep Apnea Market To Reach Almost $10.3Bn By 2022

The market for devices to monitor and treat sleep apnea and its complications is set to grow by 7.3% annually ...

Device Week Podcast



Discussed in this episode:


Boston Scientific's TAVR Pipeline Delayed; FDA Approval Of Acurate neo2 Set For 2024

The SCOPE II results could have helped support a PMA for Acurate neo2 in 2021, but the trial missed its primary endpoint, and the REPRISE IV trial of ...

Approvals Clinical Trials






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Policy & Regulation Explore this Topic

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Election 2020: Medtech PAC Funds Go To US House Reps Boosting Trade Deals, COVID-19 Tests

Medtech Insight takes a look at political action committee money that medtech entities have been contributing to US House members, and device-friendly legislation those lawmakers have backed.

Policy Elections Legislation

COVID-19: FDA Expands List Of Remote Monitoring Devices That Don’t Need Premarket Notification

The US agency has added gaseous-phase carbon-dioxide gas analyzers to its list of products that – during the coronavirus pandemic – will not require a new premarket notification to be marketed for remote monitoring.

FDA Enforcement Policy

Latest From Policy & Regulation

QUOTED. 30 October 2020. Dan Buehner.

Edwards Lifesciences has slashed the number of open CAPAs at its Draper, UT, manufacturing site by more than half. See what the company’s director of quality engineering, Dan Buehner, said about it here.

Quoted Quality Control

Experts Call For Unifying Measures For EU Political And Regulatory Oversight

Just as the MDR and IVDR are being implemented, increasing regulatory divergence in Europe is a growing danger to patient safety throughout the EU, not least through increasing costs and impacting device availability.

EU Europe

IVDR Implementation Not Yet On Track: What The Diagnostics Sector Needs To Do

It’s time to focus on how the diagnostics sector will comply with the EU’s IVD Regulation. TÜV SÜD expert, Andreas Stange, explains why the IVD industry could be in trouble and what must be done now.

EU Compliance

MDUFA V: FDA Looks For More User-Fee Investments; Industry Wants To Work With What’s There

US FDA commissioner Stephen Hahn argued on 27 October that his device center should consider more user-fee investments to alleviate the agency’s workload and address new innovations – but industry wants the FDA to finish hiring and work with what’s there.

User Fees FDA

EU Framework For Patient Preference Studies Under Review

An EU public-private collaborative project is seeking validation from regulators and health technology assessment bodies regarding its proposed best practice approach to conducting patient preference studies.

Health Technology Assessment Regulation

Warning Letter Roundup & Recap – 27 October 2020

No device-related warning letters were released by the US FDA the week of 27 October.

Device Warning Letters FDA

Quality Control & Compliance Explore this Topic

Set Alert for Quality Control

QUOTED. 30 October 2020. Dan Buehner.

Edwards Lifesciences has slashed the number of open CAPAs at its Draper, UT, manufacturing site by more than half. See what the company’s director of quality engineering, Dan Buehner, said about it here.

Quoted Quality Control

FDA Bumps PMA Compliance Date For AED Accessories To February 2022

The US agency is giving manufacturers of automated external defibrillator accessories roughly 15 more months to comply with a 2015 final order that requires them to file premarket submissions with the agency.

FDA Guidance Documents

One Edwards Lifesciences Site Chopped Its Open CAPAs By Half. Here’s How Your Firm Can Too

Two Edwards quality experts explain to Medtech Insight how the firm is benefiting by using a new CAPA framework that shifts corrective and preventive action from a one-size-fits-all method to a more nuanced approach that separates higher-risk events from others that don’t need to be elevated to the level of a traditional CAPA.

Quality Control Compliance

Commercial Explore this Topic

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Medtronic Expands ENT Portfolio With Ai Biomed Acquisition, NIM Vital Clearance

Ai Biomed’s PTeye helps to identify parathyroid tissue during thyroid surgery. Medtronic ENT also announced the FDA clearance of its NIM Vital electromyographic system for nerve monitoring during surgery.

Approvals M & A Companies

Latest From Commercial

Cala Health Receives FDA Breakthrough Designation For Wrist-Worn Tremor Device

Cala Health expects to initiate telemedicine-based clinical trials of Cala Trio in patients with Parkinson’s disease by year-end.

Approvals Neurology

Device Week, 23 October 2020 – Conference Spotlight TCT, HLTH

In this week’s podcast, Medtech Insight's managing editor Marion Webb has an update from the virtual HLTH panel discussions on telehealth and robotics. Deputy editor Reed Miller discusses trial results from Boston Scientific’s next-generation Accurate neo2 self-expanding aortic valve presented during the Transcatheter Cardiovascular Therapeutics (TCT) meeting. 

Device Week Telehealth

J&J Faces Fraud Claims From Merger With Surgical Robot Firm

Investors in surgical robotics company Auris say Johnson & Johnson failed to support the company per their merger agreement.

Legal Issues Commercial

Edwards Returns To Growth In The Third Quarter

The company’s third-quarter sales were up 4% year-over-year as transcatheter aortic valve replacement procedure volumes returned to pre-pandemic levels.

Companies Clinical Trials

Execs On The Move: New CEO For Glycorex; Senior Execs For NuVasive And Itamar Medical

Biovica exec becomes Glycorex Transplantation CEO; Perimeter Medical Imaging AI CFO promoted to CEO; new blood at Aquarius Surgical Technologies, Itamar Medical and NuVasive; and more.

Commercial Appointments

Abbott’s 3Q $8.9Bn Sales Beat Wall Street Consensus, Medtech Sales Up 3.4%

Abbott reported strong sales for diagnostics and devices in the third quarter and raised its full-year EPS guidance to $3.55 per share.

Financing Diagnostics

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Butterfly Network Expands Efforts To Improve COVID-19 Diagnosis With Ultrasound

A trial in Italy sponsored by Butterfly Network showed the company’s portable ultrasound system can help identify patients with COVID-19 pneumonia, including those missed by PCR testing.

Coronavirus COVID-19 Clinical Trials Diagnostic Imaging

Latest From Research & Development

FDA Approves Medtronic’s Abre Venous Stent

The approval is based on the results ABRE clinical study, which showed the stent improved patency iliofemoral veins in 88% of cases with a 2% rate of major adverse events.

Approvals Clinical Trials

Cala Health Receives FDA Breakthrough Designation For Wrist-Worn Tremor Device

Cala Health expects to initiate telemedicine-based clinical trials of Cala Trio in patients with Parkinson’s disease by year-end.

Approvals Neurology

Abbott’s 3Q $8.9Bn Sales Beat Wall Street Consensus, Medtech Sales Up 3.4%

Abbott reported strong sales for diagnostics and devices in the third quarter and raised its full-year EPS guidance to $3.55 per share.

Financing Diagnostics

Long-Term Data Confirm Durability Of Medtronic’s DTM Back Pain Therapy

A randomized trial demonstrated the superiority of Medtronic’s DTM spinal cord stimulation waveform over conventional spinal cord stimulation for treating back pain.

Clinical Trials Innovation

Two Studies Support Short Dual Antiplatelet Therapy With Abbott’s Xience DES

Results from two trials confirm patients at high risk of bleeding treated with Abbott’s Xience stent can be safely treated with short regimens of dual antiplatelet therapy.

Clinical Trials Research & Development

Medtronic, The Foundry Invest In New Transcatheter Mitral Repair Technology

The deal gives Medtronic the exclusive right to acquire Half Moon Medical, a start-up developing a mitral valve repair system to compete with Abbott’s MitraClip.

Clinical Trials Deals
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