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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.
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.
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.
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.
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.
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.
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.
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.
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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.
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.”
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.
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.
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.
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.
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.
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).
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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.
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.
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.
OUTLOOK 2021
Forward-looking features and special content, including Scrip 100, Medtech 100 and Generics Top 50 industry rankings
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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.
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.
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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).
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.
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.
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