FDA Approves Shockwave Coronary Intravascular Lithotripsy System

Shockwave Medical received a FDA premarket approval for its C2 coronary intravascular lithotripsy-based calcification remedy and announced its 2020 results, in line with expectations.

Shockwave Medical’s IVL System
Shockwave Medica's IVL system • Source: Shockwave Medical

Shockwave Medical has received US Food and Drug Administration approval for its C2 coronary intravascular lithotripsy (IVL) therapy system.

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

 

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

 
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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

 
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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

 

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

 
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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

 

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

 
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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.