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FDA Warns: Don’t Use CovClear, ImmunoPass COVID-19 Tests; High-Risk Class I Recall Underway

The US FDA said on 28 January that it’s worried about the potential for false-negative or false-positive results given from the diagnostics, which were made by Empowered Diagnostics. The company has recalled the tests because they weren’t authorized by the agency for use in the US.

Recalls Diagnostics Coronavirus COVID-19

EU Advises Third Country COVID-19 Test Manufacturers To Contact Notified Bodies Now

Manufacturers of COVID-19 tests may now have longer to comply with the IVD Regulation. But those from third countries need to be aware of the deadlines and hurdles ahead and act now.

EU Europe Medical Device

2 Become 1: FDA Takes Trip Down Combo Products Premarket Pathway In New Guidance

The 28 January guidance from the US FDA explains the premarket and submission process for combination products and offers tips to manufacturers as they consider which of the agency’s lead centers should review their product.

Combination Products Guidance Documents FDA

Exec Chat: AngelMed Rolls Out Guardian Cardiac Monitor, Prepares To Go Public

Angel Medical Systems accomplished several major milestones in 2021, including FDA approval of the second-generation version of The Guardian implantable cardiac detection monitor and patient-warning system for acute coronary syndrome events. CEO Brad Snow talked to Medtech Insight about the company's plans to commercialize The Guardian in 2022.

Exec Chats Business Strategies Commercial

Spotlight On MTI Podcasts

Speaking Of Medtech, Ep. 6: 2022 Predictions For FDA’s Device Center

In this episode of Speaking Of Medtech we’re breaking out the crystal ball to give a few predictions of what could be in store this year for industry and the US FDA’s Center for Devices and Radiological Health. From the ongoing COVID-19 pandemic to digital devices and facility inspections, there’s a lot of ground to cover.

Speaking of Medtech FDA

From The Farm To The OR: Pigs Show More Promise As Organ Donors

Surgeons in Alabama have taken a giant leap forward to making pig kidneys a viable option for humans with end-stage renal disease.

New Science Clinical Trials Research & Development

Comments On US FDA OTC Hearing Aid Proposed Rule Urge Clarification On Recommended Users

More than 1,000 comments were submitted by professional and civic organizations, trade groups and consumers FDA proposed rule on allowing OTC sales of hearing aids intended for consumers with mild to moderate hearing loss.

OTC Devices Ear FDA

Minute Insight: Confidence Plus Shows Medical Device Innovation Can Start In The Home

Ostomy bags can leak and cause problems for patients and health care workers, so Anne Inch created a device in her attic to solve that problem and has begun to commercialize it.

StartUps and SMEs Innovation Consumer

Device Week Podcast


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Policy & Regulation Explore this Topic

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UK Tests Streamlined Assessment Of Requests For Trials Involving Drugs And Devices

A new UK pilot involves co-ordinated reviews by the medicine and medical device divisions of the UK MHRA, as well as the research ethics committee. 

United Kingdom Clinical Trials Regulation

Senators, State AGs Differ On Whether Further Federal Regulation Needed For OTC Hearing Aids

Sens. Warren and Grassley say federal regulation is needed to ensure consumers in all states benefit from OTC hearing aids. State AGs, on the other hand, have asked the FDA to “define preemption terms in a way that recognizes the important role state and local entities play in protecting consumers.”

Policy Durable Medical Equipment Consumer

Latest From Policy & Regulation

American Indians, Other Medicare Minorities Disproportionately Affected By COVID-19: CMS

Besides Asians and Pacific Islanders, other racial minorities had higher instances of COVID-19 infections and hospitalizations compared to their white counterparts, the Medicare agency said.

Policy Coronavirus COVID-19

Want Better Clinical Trial Design? Get Early Patient Input, Says FDA

A new guidance document from the US regulatory agency reasons that getting early feedback from patient advocates in the trial-design process could improve enrollment, trial completion and data quality.

Clinical Trials Guidance Documents

Going PRO: FDA Suggests Best Practices For Choosing, Changing Patient-Reported Outcome Tools

Patient-Reported Outcome (PRO) instruments are the focus of a 26 January final guidance from the US agency. Sponsors can lean on the guidance when selecting, developing or modifying tools for patient data collection.

Guidance Documents FDA

EU IVDR Amending Regulation Published And Staggered Grace Periods Now Official

The text amending the IVD Regulation, taking the pressure of the entire sector, has now been officially published. But clarification is needed regarding timelines for compliance for in-house IVDs.

EU Europe

Further Transition Period Mooted As Eurasian Device System Comes Into Force To Little Fanfare

After a five-year regulatory transition, access to the Eurasian Economic Union market for new medtech products must now take place via the EAEU system only. But having got off to a slow start, further system transitional measures are now under discussion.     

EAEU Regulation

FDA To Convene Workshop On Using Ablation Therapy To Treat Certain Lung Cancers

The US regulatory agency will hold a two-day online workshop in April on how transbronchoscopic thermal ablation devices may be developed to treat intermediate-stage lung tumors known as oligometastases to the lung (OML).

Regulation Research & Development

Quality Control & Compliance Explore this Topic

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Latest From Quality Control

Philips Trilogy Evo Ventilators, Repair Kits Recalled Because Supplier Used Nonconforming Foam

Specific Trilogy Evo ventilators and their repair kits have been recalled because a Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) foam, a nonconforming material, in the manufacture of their muffler assembly. The US FDA gave the recall a high-risk designation on 26 January.

Recalls Safety

EU IVDR Amending Regulation Published And Staggered Grace Periods Now Official

The text amending the IVD Regulation, taking the pressure of the entire sector, has now been officially published. But clarification is needed regarding timelines for compliance for in-house IVDs.

EU Europe

Lawmakers Ask FTC To Investigate Price Gouging Of COVID-19 Tests

US Sens. Ed Markey and Sidney Blumenthal are requesting the Federal Trade Commission to use its power to prevent bad actors from taking advantage of the pandemic.

Coronavirus COVID-19 Diagnostics

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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Playing Big: Akili To Be Bought By Chamath Palihapitiya’s SPAC In $1Bn Deal

Akili Interactive, which developed a video game to treat ADHD, will go public with one of Palihapitiya’s blank-check companies. The proceeds will be used to launch the FDA-cleared EndeavorRx digital therapeutics.

M & A Digital Health Business Strategies

Latest From Commercial

Device Week, 28 January 2021 – Pigs Could Help Resolve Transplant Organ Shortages. Here’s How.

In this week’s podcast,  senior reporter Brian Bossetta discusses two recent operations that show the promise genetically modified pig organs may hold for patients in need of new organs.

Device Week Clinical Trials

Distalmotion’s Robotic Surgery Approach Attracts New Strategic Expertise And Funding

Robot’s surgeon or surgeon’s robot? Swiss innovator Distalmotion is pressing ahead with the latter approach having added new directors, and new funding and commercial scale-up resources to further the global vision for its laparoscopic-robotic surgery tool with a difference.

Commercial Robotic Surgery

Digital Health Roundup: Digital Therapeutics, Restoring Function, Deals, Investing And Lobbying

In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights the push behind digital therapeutics, Abbott’s biowearable line, Exec Chats with iRhythm and Cognetivity, Right To Repair rules for tech, and FDA's guidance on 3D-printing.

Digital Health Artificial Intelligence

Pear CEO Sees Fulfilment And Reimbursement Challenges Ahead

Medtech Insight spoke to Pear Therapeutics CEO Corey McMann about the emerging digital therapeutics market and his company’s future now that it has the first PDT covered by Medicaid.

Digital Health Consumer

Lawmakers Ask FTC To Investigate Price Gouging Of COVID-19 Tests

US Sens. Ed Markey and Sidney Blumenthal are requesting the Federal Trade Commission to use its power to prevent bad actors from taking advantage of the pandemic.

Coronavirus COVID-19 Diagnostics

Exec Chat: Ligence CFO Addresses The Challenges Faced By An Early-Stage AI Company

Medtech Insight spoke to the chief financial officer of Ligence, a Lithuanian start-up developing AI for echocardiography, to find out more about its commercial strategy, and problems it faces with commercialization.

Exec Chats Diagnostic Imaging

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Nevro And Medtronic Announce FDA Approval Of Spinal Cord Stimulation Label Expansions

The FDA approved a diabetic peripheral neuropathy indication for Medtronic’s Intellis and Vanta spinal cord stimulators a few days after expanding the indication for Senza Nevro’s spinal cord stimulation system to include non-surgical refractory back pain.

Approvals Clinical Trials Neurology

Latest From Research & Development

Device Week, 28 January 2021 – Pigs Could Help Resolve Transplant Organ Shortages. Here’s How.

In this week’s podcast,  senior reporter Brian Bossetta discusses two recent operations that show the promise genetically modified pig organs may hold for patients in need of new organs.

Device Week Clinical Trials

Want Better Clinical Trial Design? Get Early Patient Input, Says FDA

A new guidance document from the US regulatory agency reasons that getting early feedback from patient advocates in the trial-design process could improve enrollment, trial completion and data quality.

Clinical Trials Guidance Documents

Digital Health Roundup: Digital Therapeutics, Restoring Function, Deals, Investing And Lobbying

In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights the push behind digital therapeutics, Abbott’s biowearable line, Exec Chats with iRhythm and Cognetivity, Right To Repair rules for tech, and FDA's guidance on 3D-printing.

Digital Health Artificial Intelligence

FDA To Convene Workshop On Using Ablation Therapy To Treat Certain Lung Cancers

The US regulatory agency will hold a two-day online workshop in April on how transbronchoscopic thermal ablation devices may be developed to treat intermediate-stage lung tumors known as oligometastases to the lung (OML).

Regulation Research & Development

Device Week, 21 January 2022 – J.P. Morgan Health Care Conference Highlights; Spotlight PneumoWave

On this week’s podcast, Medtech Insight's Reed Miller, Marion Webb and Barnaby Pickering provide a recap of our J.P. Morgan Health Care conference coverage including Abbott, Dexcom, Zimmer Biomet and Nuvasive and spotlight Scottish company PneumoWave. 

Device Week Business Strategies

Exec Chat: Dexcom’s CEO Bullish On Year Ahead With G7 CGM Launch, Dexcom One CGM Expansion

In an interview with Medtech Insight following the J.P. Morgan Health Care Conference, Dexcom CEO Kevin Sayer discussed marketing plans for the next-generation G7 continuous glucose monitoring system and for the simpler CGM, Dexcom One, and outlined plans ahead.

Business Strategies Diabetic Care
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