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Medtronic Earns CE Mark For Affera Ablation System, Touts New PFA Results

 
• By Reed Miller

Results of the PULSED AF trial confirm that Medtronic’s PulseSelect pulsed field ablation is safe and effective for atrial fibrillation ablation. The company will likely incorporate PulseSelect into its Affera cardiac mapping and ablation system, which will soon be available in Europe.

Atrial fibrillation and normal or abnormal heart rate rythm as a cardiac disorder as a human organ with healthy and unhealthy ecg monitoring in a 3D illustration style.
• Source: Shutterstock

Medtronic’s Affera mapping and ablation system, which includes the Sphere-9 and the Affera Prism-1 mapping software, earned a CE mark and will be available in Europe by the middle of 2023, the company announced on 15 March.

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Quibim Extends Into US Market With FDA Authorization Of QP-Prostate CAD

 
• By Natasha Barrow

The US FDA's clearance of QP-Prostate CAD positions the company to support US health care providers and growing markets for fusion biopsy and focal therapy, said Quibim CEO and founder Angel Alberich-Bayarri.

Dexcom Eyes US FDA Clearance For 15-Day CGM, But Insurance Coverage Remains Uncertain

 
• By Shubham Singh

Tempering expectations on the immediate market impact for the upgraded continuous glucose monitor, Dexcom notes insurance coverage and pump integrations will take time to finalize.

Sebela’s Miudella Is First Hormone-Free IUD To Win FDA Approval In 40 Years

 
• By Elizabeth Orr

The device, which uses a flexible frame to ease insertion and minimize the dose of copper, is 99% effective in preventing pregnancy. Clinical trial lead David Turok said it represents “a real advance” in contraceptive options.

Medtronic Widens Parkinson’s aDBS Opportunity With Key US Approvals

 
• By Natasha Barrow

Medtronic’s US FDA approval for BrainSense aDBS and BrainSense EI software features of the Percept neurostimulator device has quickly followed CE marking in January.

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AI-Based Screening Tool For Musculoskeletal Issues Gets US FDA Warning Letter

 
• By Elizabeth Orr

Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.

New FDA Commissioner Makary Could Face Turbulent Waters

 
• By Sarah Karlin-Smith

Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.

Research Finds Benefit From DME Suppliers For People Living With Diabetes

 
• By Elizabeth Orr

People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.